Associate QA Software Validation Engineer
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must not create sections with filler like "commensurate with experience". Pay section: we have salary range and bonus info, so include Pay.
Benefits: we have list of benefits; include Benefits.
Skills: KSAs list; include Skills.
Qualifications: include Required Qualifications and Preferred Qualifications maybe under Qualifications heading.
Responsibilities: Local Position Duties list.
About the role: Position Summary paragraph.
We must not include duplicated lines. Also need to remove EEO etc. Also remove scam warning paragraphs. Also remove "Please be aware that recruitment related scams..." etc. Also remove "BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers..." etc. Also remove "Please be advised that the receipt of satisfactory responses..." etc. Also remove accommodation info? That might be considered EEO/legal; but it's about reasonable accommodation for disability. Might be considered EEO/legal boilerplate; better to remove. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So accommodation request likely falls under EEO/legal; remove.
Thus final HTML includes sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay.
We need to ensure we don't include Schedule.
Now craft content.
About the role: Use Position Summary paragraph: "Develops and supports the validation and lifecycle management of GxP computerized systems by authoring and executing validation documentation, conducting risk assessments, maintaining regulatory compliance, supporting investigations and change controls, and ensuring systems remain in a validated state throughout their lifecycle. Ensures GxP systems meet regulatory compliance as well as conformance to site and global procedures."
That's the summary.
Responsibilities: list from Local Position Duties bullet points.
Let's extract each duty:
- Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports.
- Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements.
- Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions.
- Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state.
- Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking.
- Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance.
- Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
- Author and revise validation SOPs and the Site Validation Master Plan as required.
- Participate in QA oversight activities for MES, calibration, maintenance and facilities.
- Reasonable, reliable attendance and punctuality is an essential job function required for this position.
- Perform all work in compliance with company quality procedures and standards.
- Perform other duties as assigned.
We could combine some as list items.
Qualifications: Required Qualifications: Bachelor degree required (Engineering, Computer Science, Life Sciences, or related field preferred), or Education Substitution: In lieu of a Bachelor's degree, 4+ years of professional relevant experience performing validation or quality engineering duties in health care or a regulated industry will be accepted. No previous experience required performing validation or quality engineering duties in health care or a regulated industry (that sentence seems contradictory; maybe it's "No previous experience required"? Actually text: "No previous experience required performing validation or quality engineering duties in health care or a regulated industry". Might be a mistake but we keep as is.)
Preferred Qualifications: A minimum of 1 year of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry. Basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Understanding of cGMPSs, GAMP, and basic validation/qualification concepts. Knowledge, Skills, And Abilities (KSAs) ... Actually KSAs is separate section.
We'll put Required Qualifications and Preferred Qualifications as
under Qualifications.
Skills: KSAs list: Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes. Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy. Written Communications - including the ability to communicate technical data in written form Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity. Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently Troubleshooting issues to identify and resolve problems efficiently Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel Must have a basic knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
We can break into list items.
Benefits: list of benefits: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves
We'll make list.
Pay: The estimated salary range for this role is between $72,100 and $91,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
We'll put as maybe with
for bullet? It's prose; we can use .
Now produce HTML fragment.
Make sure no extra text outside.
Let's craft:
About the role
Develops and supports the validation and lifecycle management of GxP computerized systems by authoring and executing validation documentation, conducting risk assessments, maintaining regulatory compliance, supporting investigations and change controls, and ensuring systems remain in a validated state throughout their lifecycle. Ensures GxP systems meet regulatory compliance as well as conformance to site and global procedures.
Responsibilities
- Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports.
- Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements.
- Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions.
- Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state.
- Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking.
- Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance.
- Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
- Author and revise validation SOPs and the Site Validation Master Plan as required.
- Participate in QA oversight activities for MES, calibration, maintenance and facilities.
- Reasonable, reliable attendance and punctuality is an essential job function required for this position.
- Perform all work in compliance with company quality procedures and standards.
- Perform other duties as assigned.
Qualifications
- Required: Bachelor degree required (Engineering, Computer Science, Life Sciences, or related field preferred), or Education Substitution: In lieu of a Bachelor's degree, 4+ years of professional relevant experience performing validation or quality engineering duties in health care or a regulated industry will be accepted. No previous experience required performing validation or quality engineering duties in health care or a regulated industry.
- Preferred: A minimum of 1 year of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry. Basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Understanding of cGMPs, GAMP, and basic validation/qualification concepts.
Skills
- Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
- Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
- Written communications – ability to communicate technical data in written form.
- Thriving in a fast‑paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
- Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
- Troubleshooting issues to identify and resolve problems efficiently.
- Skilled in MS Office tools (Outlook, Teams, Word, Excel).
- Basic knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
Benefits
- Choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options.
- Company‑provided life and accidental death insurance.
- Short and long‑term disability insurance.
- Retirement plan including a generous non‑discretionary employer contribution and employer match.
- Adoption assistance.
- Wellness programs.
- Employee assistance program.
- Commuter benefits.
- Various voluntary benefit offerings.
- Discount programs.
- Parental leaves.
Pay
The estimated salary range for this role is between $72,100 and $91,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
Check for any leftover boilerplate: we removed EEO etc
for prose. We must not create sections with filler like "commensurate with experience". Pay section: we have salary range and bonus info, so include Pay. Benefits: we have list of benefits; include Benefits. Skills: KSAs list; include Skills. Qualifications: include Required Qualifications and Preferred Qualifications maybe under Qualifications heading. Responsibilities: Local Position Duties list. About the role: Position Summary paragraph. We must not include duplicated lines. Also need to remove EEO etc. Also remove scam warning paragraphs. Also remove "Please be aware that recruitment related scams..." etc. Also remove "BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers..." etc. Also remove "Please be advised that the receipt of satisfactory responses..." etc. Also remove accommodation info? That might be considered EEO/legal; but it's about reasonable accommodation for disability. Might be considered EEO/legal boilerplate; better to remove. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So accommodation request likely falls under EEO/legal; remove. Thus final HTML includes sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay. We need to ensure we don't include Schedule. Now craft content. About the role: Use Position Summary paragraph: "Develops and supports the validation and lifecycle management of GxP computerized systems by authoring and executing validation documentation, conducting risk assessments, maintaining regulatory compliance, supporting investigations and change controls, and ensuring systems remain in a validated state throughout their lifecycle. Ensures GxP systems meet regulatory compliance as well as conformance to site and global procedures." That's the summary. Responsibilities: list from Local Position Duties bullet points. Let's extract each duty: - Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports. - Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements. - Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions. - Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state. - Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking. - Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance. - Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS). - Author and revise validation SOPs and the Site Validation Master Plan as required. - Participate in QA oversight activities for MES, calibration, maintenance and facilities. - Reasonable, reliable attendance and punctuality is an essential job function required for this position. - Perform all work in compliance with company quality procedures and standards. - Perform other duties as assigned. We could combine some as list items. Qualifications: Required Qualifications: Bachelor degree required (Engineering, Computer Science, Life Sciences, or related field preferred), or Education Substitution: In lieu of a Bachelor's degree, 4+ years of professional relevant experience performing validation or quality engineering duties in health care or a regulated industry will be accepted. No previous experience required performing validation or quality engineering duties in health care or a regulated industry (that sentence seems contradictory; maybe it's "No previous experience required"? Actually text: "No previous experience required performing validation or quality engineering duties in health care or a regulated industry". Might be a mistake but we keep as is.) Preferred Qualifications: A minimum of 1 year of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry. Basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Understanding of cGMPSs, GAMP, and basic validation/qualification concepts. Knowledge, Skills, And Abilities (KSAs) ... Actually KSAs is separate section. We'll put Required Qualifications and Preferred Qualifications as
- under Qualifications.
Skills: KSAs list: Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes. Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy. Written Communications - including the ability to communicate technical data in written form Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity. Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently Troubleshooting issues to identify and resolve problems efficiently Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel Must have a basic knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
We can break into list items.
Benefits: list of benefits: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options Company-Provided Life and Accidental Death Insurance Short and Long-Term Disability Insurance Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance Wellness Programs Employee Assistance Program Commuter Benefits Various voluntary benefit offerings Discount programs Parental leaves
We'll make list.
Pay: The estimated salary range for this role is between $72,100 and $91,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
We'll put as
- Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports.
- Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements.
- Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions.
- Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state.
- Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking.
- Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance.
- Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
- Author and revise validation SOPs and the Site Validation Master Plan as required.
- Participate in QA oversight activities for MES, calibration, maintenance and facilities.
- Reasonable, reliable attendance and punctuality is an essential job function required for this position.
- Perform all work in compliance with company quality procedures and standards.
- Perform other duties as assigned.
- Required: Bachelor degree required (Engineering, Computer Science, Life Sciences, or related field preferred), or Education Substitution: In lieu of a Bachelor's degree, 4+ years of professional relevant experience performing validation or quality engineering duties in health care or a regulated industry will be accepted. No previous experience required performing validation or quality engineering duties in health care or a regulated industry.
- Preferred: A minimum of 1 year of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry. Basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Understanding of cGMPs, GAMP, and basic validation/qualification concepts.
- Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
- Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
- Written communications – ability to communicate technical data in written form.
- Thriving in a fast‑paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
- Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
- Troubleshooting issues to identify and resolve problems efficiently.
- Skilled in MS Office tools (Outlook, Teams, Word, Excel).
- Basic knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
- Choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options.
- Company‑provided life and accidental death insurance.
- Short and long‑term disability insurance.
- Retirement plan including a generous non‑discretionary employer contribution and employer match.
- Adoption assistance.
- Wellness programs.
- Employee assistance program.
- Commuter benefits.
- Various voluntary benefit offerings.
- Discount programs.
- Parental leaves.
maybe with
- for bullet? It's prose; we can use
. Now produce HTML fragment. Make sure no extra text outside. Let's craft:
About the role
Develops and supports the validation and lifecycle management of GxP computerized systems by authoring and executing validation documentation, conducting risk assessments, maintaining regulatory compliance, supporting investigations and change controls, and ensuring systems remain in a validated state throughout their lifecycle. Ensures GxP systems meet regulatory compliance as well as conformance to site and global procedures.
Responsibilities
Qualifications
Skills
Benefits
Pay
The estimated salary range for this role is between $72,100 and $91,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
Check for any leftover boilerplate: we removed EEO etc