Validation Engineer
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences.
We need to decide which sections to include based on content.
We have Company Description (general about company). Could be "About the role"? Actually "About the role" is for role description. We have Position Overview describing role. Could use "About the role" heading for that. Then "Responsibilities" heading for Key Responsibilities list. Then "Qualifications And Requirements" could be split into "Qualifications" and "Requirements" or "Skills". The instruction says we can use headings like Qualifications, Skills, Benefits, Pay, Schedule. We have qualifications and requirements (education, technical experience, knowledge, skills, abilities). Could combine into "Qualifications" and maybe "Skills". But we should not create thin sections. Perhaps one "Qualifications" section covering education, experience, knowledge, skills, abilities. Then maybe "Benefits" section from Total Rewards Program. There's mention of total rewards: compensation, benefits, remote work/flexibility, development, recognition, culture. Also mention flexible paid time off, company-paid holidays, flexible working hours, fully remote work options, office locations. That's benefits info. So we can include a Benefits section.
We should not include Pay or Schedule unless explicitly stated. There's no specific pay or schedule numbers. So omit those.
We need to remove boilerplate: Legal Statement, EEO, etc. Also remove "Essential Functions Physical Demands" and "Work Environment" maybe? Those are substantive? They describe physical demands and work environment. Could be considered part of role description but not required headings. The instruction: include a section ONLY when the posting has real, specific content for it. We could include them under "About the role" or as separate sections like "Working Conditions". But we don't have a heading for that in allowed list. Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should map content to those.
Thus:
- About the role: combine Company Description and Position Overview? Actually Company Description is about company, not role. But we could still put under About the role? Might be odd. Perhaps we could have two sections: "About the company" not allowed. But we could incorporate company description into About the role as context. The instruction says use headings e.g. About the role, Responsibilities, etc. It doesn't forbid other headings? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). That suggests we should use those headings; we could also use other headings if needed? It says "use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are examples; we could use others but better to stick to those. We'll try to map.
Thus:
About the role
- include Position Overview (maybe also company description as context). We'll include both.
Responsibilities
- list from Key Responsibilities.
Qualifications
- include Education, Technical Experience, Knowledge, Skills, And Abilities (maybe combine). Could also have Skills
but we already have Qualifications covering skills. To avoid thin sections, we can have one Qualifications section.
Benefits
- from Total Rewards Program.
We must not include Pay or Schedule.
We need to remove duplicated lines, boilerplate.
Let's extract content.
Company Description: paragraphs about Syner-G mission, culture, awards, etc.
Position Overview: paragraph about seeking Validation Engineer with 4-7 years experience, responsibilities.
Key Responsibilities: bullet list (semicolon separated). We'll convert to - .
Qualifications And Requirements: sections: Education, Technical Experience, Knowledge, Skills, And Abilities.
We'll combine.
Total Rewards Program: paragraph about total rewards, base salary, annual incentive, robust benefit offerings, recognition, career development, generous flexible paid time off, company-paid holidays, flexible working hours, fully remote work options, office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Also note about visa sponsorship.
We should keep that as Benefits.
We must not include legal statement, EEO, etc.
Now produce HTML.
We'll start with
About the role
then containing company description + position overview? Might be long but okay.
Better to split: maybe two paragraphs: first company description, second position overview.
Then
Responsibilities
with each responsibility.
Then Qualifications
maybe for education, experience, knowledge, skills, abilities. Could be list.
Then Benefits
for benefits.
Let's extract specifics.
Company Description text:
"A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com"
We should keep all that.
Position Overview:
"We are seeking a Validation Engineer with 4-7 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures. The Validation Engineer will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements."
Now Responsibilities list (the bullet points). They are separated by periods but we can treat each sentence as a bullet.
List:
- Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.
- Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.
- Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.
- Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.
- Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
- Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.
- Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.
- Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
- Prepare validation summary reports and support qualification and requalification activities.
- Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
- Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.
- Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
- Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.
- Maintain validation documentation in accordance with quality system requirements and document control procedures.
Now Qualifications:
Education: Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
Technical Experience:
- 4-7 years of validation experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
- Experience supporting equipment qualification, computerized systems validation (CSV), process validation, or automation system validation activities.
- Experience authoring and executing validation documentation, including IQ, OQ, PQ protocols and validation reports.
- Familiarity with risk-based validation methodologies and regulatory expectations within GMP environments.
- Experience supporting validation activities for MES, eBR, or manufacturing automation systems is preferred.
- Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar manufacturing systems is preferred.
- Experience supporting audits, inspections, deviation investigations, CAPAs, and change controls is preferred.
Knowledge, Skills, And Abilities:
- Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.
- Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
- Strong technical writing and documentation skills with attention to detail.
- Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.
- Strong organizational, analytical, and problem-solving abilities.
- Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
- Ability to manage multiple assignments and priorities in a fast-paced project environment.
- Working knowledge of validation lifecycle deliverables and quality system processes.
- Ability to work independently while contributing effectively within cross-functional teams.
Now Benefits from Total Rewards Program:
Paragraph: "We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences. We need to decide which sections to include based on content. We have Company Description (general about company). Could be "About the role"? Actually "About the role" is for role description. We have Position Overview describing role. Could use "About the role" heading for that. Then "Responsibilities" heading for Key Responsibilities list. Then "Qualifications And Requirements" could be split into "Qualifications" and "Requirements" or "Skills". The instruction says we can use headings like Qualifications, Skills, Benefits, Pay, Schedule. We have qualifications and requirements (education, technical experience, knowledge, skills, abilities). Could combine into "Qualifications" and maybe "Skills". But we should not create thin sections. Perhaps one "Qualifications" section covering education, experience, knowledge, skills, abilities. Then maybe "Benefits" section from Total Rewards Program. There's mention of total rewards: compensation, benefits, remote work/flexibility, development, recognition, culture. Also mention flexible paid time off, company-paid holidays, flexible working hours, fully remote work options, office locations. That's benefits info. So we can include a Benefits section. We should not include Pay or Schedule unless explicitly stated. There's no specific pay or schedule numbers. So omit those. We need to remove boilerplate: Legal Statement, EEO, etc. Also remove "Essential Functions Physical Demands" and "Work Environment" maybe? Those are substantive? They describe physical demands and work environment. Could be considered part of role description but not required headings. The instruction: include a section ONLY when the posting has real, specific content for it. We could include them under "About the role" or as separate sections like "Working Conditions". But we don't have a heading for that in allowed list. Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we should map content to those. Thus: - About the role: combine Company Description and Position Overview? Actually Company Description is about company, not role. But we could still put under About the role? Might be odd. Perhaps we could have two sections: "About the company" not allowed. But we could incorporate company description into About the role as context. The instruction says use headings e.g. About the role, Responsibilities, etc. It doesn't forbid other headings? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). That suggests we should use those headings; we could also use other headings if needed? It says "use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are examples; we could use others but better to stick to those. We'll try to map.
Thus:
About the role
- include Position Overview (maybe also company description as context). We'll include both.
Responsibilities
- list from Key Responsibilities.
Qualifications
- include Education, Technical Experience, Knowledge, Skills, And Abilities (maybe combine). Could also have Skills
but we already have Qualifications covering skills. To avoid thin sections, we can have one Qualifications section.
Benefits
- from Total Rewards Program.
We must not include Pay or Schedule.
We need to remove duplicated lines, boilerplate.
Let's extract content.
Company Description: paragraphs about Syner-G mission, culture, awards, etc.
Position Overview: paragraph about seeking Validation Engineer with 4-7 years experience, responsibilities.
Key Responsibilities: bullet list (semicolon separated). We'll convert to - .
Qualifications And Requirements: sections: Education, Technical Experience, Knowledge, Skills, And Abilities.
We'll combine.
Total Rewards Program: paragraph about total rewards, base salary, annual incentive, robust benefit offerings, recognition, career development, generous flexible paid time off, company-paid holidays, flexible working hours, fully remote work options, office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Also note about visa sponsorship.
We should keep that as Benefits.
We must not include legal statement, EEO, etc.
Now produce HTML.
We'll start with
About the role
then containing company description + position overview? Might be long but okay.
Better to split: maybe two paragraphs: first company description, second position overview.
Then
Responsibilities
with each responsibility.
Then Qualifications
maybe for education, experience, knowledge, skills, abilities. Could be list.
Then Benefits
for benefits.
Let's extract specifics.
Company Description text:
"A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com"
We should keep all that.
Position Overview:
"We are seeking a Validation Engineer with 4-7 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures. The Validation Engineer will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements."
Now Responsibilities list (the bullet points). They are separated by periods but we can treat each sentence as a bullet.
List:
- Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.
- Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.
- Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.
- Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.
- Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
- Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.
- Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.
- Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
- Prepare validation summary reports and support qualification and requalification activities.
- Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
- Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.
- Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
- Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.
- Maintain validation documentation in accordance with quality system requirements and document control procedures.
Now Qualifications:
Education: Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
Technical Experience:
- 4-7 years of validation experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
- Experience supporting equipment qualification, computerized systems validation (CSV), process validation, or automation system validation activities.
- Experience authoring and executing validation documentation, including IQ, OQ, PQ protocols and validation reports.
- Familiarity with risk-based validation methodologies and regulatory expectations within GMP environments.
- Experience supporting validation activities for MES, eBR, or manufacturing automation systems is preferred.
- Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar manufacturing systems is preferred.
- Experience supporting audits, inspections, deviation investigations, CAPAs, and change controls is preferred.
Knowledge, Skills, And Abilities:
- Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.
- Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
- Strong technical writing and documentation skills with attention to detail.
- Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.
- Strong organizational, analytical, and problem-solving abilities.
- Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
- Ability to manage multiple assignments and priorities in a fast-paced project environment.
- Working knowledge of validation lifecycle deliverables and quality system processes.
- Ability to work independently while contributing effectively within cross-functional teams.
Now Benefits from Total Rewards Program:
Paragraph: "We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible
About the role
- include Position Overview (maybe also company description as context). We'll include both.Responsibilities
- list from Key Responsibilities.Qualifications
- include Education, Technical Experience, Knowledge, Skills, And Abilities (maybe combine). Could also haveSkills
but we already have Qualifications covering skills. To avoid thin sections, we can have one Qualifications section.Benefits
- from Total Rewards Program. We must not include Pay or Schedule. We need to remove duplicated lines, boilerplate. Let's extract content. Company Description: paragraphs about Syner-G mission, culture, awards, etc. Position Overview: paragraph about seeking Validation Engineer with 4-7 years experience, responsibilities. Key Responsibilities: bullet list (semicolon separated). We'll convert to- .
Qualifications And Requirements: sections: Education, Technical Experience, Knowledge, Skills, And Abilities.
We'll combine.
Total Rewards Program: paragraph about total rewards, base salary, annual incentive, robust benefit offerings, recognition, career development, generous flexible paid time off, company-paid holidays, flexible working hours, fully remote work options, office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Also note about visa sponsorship.
We should keep that as Benefits.
We must not include legal statement, EEO, etc.
Now produce HTML.
We'll start with
About the role
thencontaining company description + position overview? Might be long but okay. Better to split: maybe two paragraphs: first company description, second position overview. Then
Responsibilities
- with each responsibility.
Then
Qualifications
- maybe for education, experience, knowledge, skills, abilities. Could be list.
Then
Benefits
- for benefits.
Let's extract specifics.
Company Description text:
"A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com"
We should keep all that.
Position Overview:
"We are seeking a Validation Engineer with 4-7 years of experience to support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures. The Validation Engineer will support MES and eBR implementation and qualification activities, working closely with cross-functional teams including Manufacturing, Validation, Automation, IT/OT, and Quality. The successful candidate will contribute to validation strategy, execution, documentation review, and system release activities while ensuring alignment with GMP and computerized systems validation requirements."
Now Responsibilities list (the bullet points). They are separated by periods but we can treat each sentence as a bullet.
List:
- Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and validation reports for equipment, utilities, facilities, computerized systems, and other GMP-regulated assets.
- Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management activities.
- Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports to ensure compliance with approved validation methodologies.
- Review eBR workflows to verify alignment with approved manufacturing processes, master batch records, and regulatory requirements.
- Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
- Assist with deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities.
- Author, execute, review, and maintain validation documentation including validation plans, protocols, reports, SOPs, URS, FRS, and design specifications.
- Support technology transfer projects by executing and documenting validation activities in accordance with project timelines and quality requirements.
- Prepare validation summary reports and support qualification and requalification activities.
- Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
- Support thermal mapping and validation activities for temperature-controlled environments and systems, as applicable.
- Assist in the resolution of audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
- Collaborate with Manufacturing, Quality, Engineering, Automation, and IT/OT teams to support successful project execution and operational readiness.
- Maintain validation documentation in accordance with quality system requirements and document control procedures.
Now Qualifications:
Education: Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
Technical Experience:
- 4-7 years of validation experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.
- Experience supporting equipment qualification, computerized systems validation (CSV), process validation, or automation system validation activities.
- Experience authoring and executing validation documentation, including IQ, OQ, PQ protocols and validation reports.
- Familiarity with risk-based validation methodologies and regulatory expectations within GMP environments.
- Experience supporting validation activities for MES, eBR, or manufacturing automation systems is preferred.
- Experience with MES platforms such as PAS-X, PharmaSuite, Syncade, Opcenter, or similar manufacturing systems is preferred.
- Experience supporting audits, inspections, deviation investigations, CAPAs, and change controls is preferred.
Knowledge, Skills, And Abilities:
- Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and computerized systems validation requirements.
- Demonstrated experience supporting MES/eBR validation or computerized system qualification activities in a regulated environment.
- Strong technical writing and documentation skills with attention to detail.
- Ability to review and interpret validation documentation, process flows, requirements specifications, and test scripts.
- Strong organizational, analytical, and problem-solving abilities.
- Effective verbal and written communication skills with the ability to collaborate across multiple functional areas.
- Ability to manage multiple assignments and priorities in a fast-paced project environment.
- Working knowledge of validation lifecycle deliverables and quality system processes.
- Ability to work independently while contributing effectively within cross-functional teams.
Now Benefits from Total Rewards Program:
Paragraph: "We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible