Senior Process Engineer
PSC Biotech® Corporation · York, PA · 3 wk ago
On-siteEngineeringFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes sections: "Your Role" with description, then bullet points under subheadings: Process Development & Technology Transfer, Manufacturing Support, Process Validation, Aseptic Processing Support, Equipment & Facility Engineering Support, Lyophilization Support, Continuous Improvement, Regulatory & Audit Support. Also "Requirements" section with bullet list. Also "Benefits" section with bullet list. Also maybe "Pay" and "Schedule" not present, so omit. Also "About the role" maybe not needed because they have "Your Role". The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should have sections: About the role, Responsibilities, Requirements, Benefits. Possibly also Qualifications? But we have Requirements which includes education and experience. Could treat Requirements as qualifications. We'll follow: About the role (paragraph), Responsibilities (list of duties grouped maybe as subheadings? But we need to use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map headings accordingly. We have "Your Role" maybe treat as "About the role"? Could use "About the role" heading and then paragraph describing role. But they said do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. So we can have
About the role
then... description of role (the paragraph after "Your Role" maybe). Then we have sub-sections like Process Development & Technology Transfer etc. Those could be under a "Responsibilities" heading? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should have sections: About the role, Responsibilities, Requirements, Benefits. Possibly also Qualifications? But we have Requirements which includes education and experience. Could treat Requirements as qualifications. We'll follow: About the role (paragraph), Responsibilities (list of duties grouped maybe as subheadings? But we need to use - for any list of duties/requirements/benefits. So we can have a
with each duty as - . However there are many subcategories; we could keep them as separate
- items, each containing the description. That satisfies using list for duties. We'll not create extra headings for each subcategory unless we want to keep them as headings but that would be extra sections; but instruction says prefer a few substantive sections over many thin ones. So we can have one Responsibilities section with a
containing each duty as - . Similarly Requirements section with
of requirements. Benefits section with of benefits.
We must preserve all substantive information; do not invent or summarize away detail. So we need to include all bullet points from the posting.
Let's extract the duties:
Under "Your Role" paragraph: "BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations. The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles."
Then subheadings with details:
Process Development & Technology Transfer:
- Lead process transfer activities from clients into BioTechnique manufacturing operations.
- Review client process documentation, batch records, process descriptions, and development reports.
- Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.
- Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.
- Support engineering runs, water runs, media fills, and demonstration batches.
Manufacturing Support:
- Provide floor support during aseptic manufacturing campaigns.
- Troubleshoot process deviations, equipment issues, yield losses, and process excursions.
- Support investigations, CAPAs, and root cause analyses.
- Drive process improvements that increase throughput, quality, and operational efficiency.
- Provide technical leadership during critical manufacturing operations.
Process Validation:
- Author and execute: Process Validation Master Plans (PVMP) PPQ Protocols and Reports Continued Process Verification (CPV) Programs Process Risk Assessments Media Fill Protocols
- Analyze process data and recommend improvements based on statistical and scientific principles.
- Support successful execution of PPQ campaigns.
Aseptic Processing Support:
- Support aseptic processing programs in compliance with: FDA cGMP regulations EU GMP Annex 1 ICH Guidelines USP requirements
- Participate in aseptic process simulations (APS/media fills).
- Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.
- Support contamination control and sterility assurance initiatives.
Equipment & Facility Engineering Support:
- Support qualification and implementation of: Filling lines Isolators RABS systems Lyophilizers CIP/SIP systems Sterile filtration systems Compounding equipment Visual inspection systems
- Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.
- Assess equipment performance and recommend improvements.
Lyophilization Support:
- Support cycle development, scale-up, and process optimization activities.
- Review thermal characterization and freeze-drying data.
- Support lyo process validation and technology transfer projects.
- Investigate cycle anomalies and process variability.
Continuous Improvement:
- Lead Lean Manufacturing and Operational Excellence initiatives.
- Utilize data analytics and process monitoring tools to improve performance.
- Support OEE improvement programs.
- Implement process robustness and reliability improvements.
Regulatory & Audit Support:
- Support internal and external audits.
- Participate in client audits and regulatory inspections.
- Provide SME support during FDA and customer inspections.
- Prepare technical documentation for regulatory submissions when required.
Now Requirements:
- Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline
- 7+ years of pharmaceutical manufacturing experience.
- Minimum 3 years supporting aseptic manufacturing operations.
- Must be authorized to work in the U.S.
- No C2C at this time.
- Demonstrated experience with:
- Sterile injectable manufacturing
- Fill-finish operations
- GMP documentation
- Process investigations
- Technology transfer
- Process validation
- Preferred Experience in a CDMO environment.
- Experience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
- Experience with lyophilization cycle development and optimization.
- Familiarity with Annex 1 contamination control requirements.
- Project management experience.
- Six Sigma Green Belt or Black Belt certification.
Benefits:
- Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
We should not include the Equal Opportunity Employment Statement (boilerplate). Also remove any duplicated lines.
Now produce HTML:
About the role
BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations. The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.
Responsibilities
- Lead process transfer activities from clients into BioTechnique manufacturing operations.
- Review client process documentation, batch records, process descriptions, and development reports.
- Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.
- Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.
- Support engineering runs, water runs, media fills, and demonstration batches.
- Provide floor support during aseptic manufacturing campaigns.
- Troubleshoot process deviations, equipment issues, yield losses, and process excursions.
- Support investigations, CAPAs, and root cause analyses.
- Drive process improvements that increase throughput, quality, and operational efficiency.
- Provide technical leadership during critical manufacturing operations.
- Author and execute: Process Validation Master Plans (PVMP) PPQ Protocols and Reports Continued Process Verification (CPV) Programs Process Risk Assessments Media Fill Protocols
- Analyze process data and recommend improvements based on statistical and scientific principles.
- Support successful execution of PPQ campaigns.
- Support aseptic processing programs in compliance with: FDA cGMP regulations EU GMP Annex 1 ICH Guidelines USP requirements
- Participate in aseptic process simulations (APS/media fills).
- Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.
- Support contamination control and sterility assurance initiatives.
- Support qualification and implementation of: Filling lines Isolators RABS systems Lyophilizers CIP/SIP systems Sterile filtration systems Compounding equipment Visual inspection systems
- Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.
- Assess equipment performance and recommend improvements.
- Support cycle development, scale-up, and process optimization activities.
- Review thermal characterization and freeze-drying data.
- Support lyo process validation and technology transfer projects.
- Investigate cycle anomalies and process variability.
- Lead Lean Manufacturing and Operational Excellence initiatives.
- Utilize data analytics and process monitoring tools to improve performance.
- Support OEE improvement programs.
- Implement process robustness and reliability improvements.
- Support internal and external audits.
- Participate in client audits and regulatory inspections.
- Provide SME support during FDA and customer inspections.
- Prepare technical documentation for regulatory submissions when required.
Requirements
- Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline
- 7+ years of pharmaceutical manufacturing experience.
- Minimum 3 years supporting aseptic manufacturing operations.
- Must be authorized to work in the U.S.
- No C2C at this time.
- Demonstrated experience with:
- Sterile injectable manufacturing
- Fill-finish operations
- GMP documentation
- Process investigations
- Technology transfer
- Process validation
- Preferred Experience in a CDMO environment.
- Experience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
- Experience with lyophilization cycle development and optimization.
- Familiarity with Annex
- with each duty as
- . However there are many subcategories; we could keep them as separate
- items, each containing the description. That satisfies using list for duties. We'll not create extra headings for each subcategory unless we want to keep them as headings but that would be extra sections; but instruction says prefer a few substantive sections over many thin ones. So we can have one Responsibilities section with a
- containing each duty as
- . Similarly Requirements section with
- of requirements. Benefits section with
- Lead process transfer activities from clients into BioTechnique manufacturing operations.
- Review client process documentation, batch records, process descriptions, and development reports.
- Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.
- Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.
- Support engineering runs, water runs, media fills, and demonstration batches.
- Provide floor support during aseptic manufacturing campaigns.
- Troubleshoot process deviations, equipment issues, yield losses, and process excursions.
- Support investigations, CAPAs, and root cause analyses.
- Drive process improvements that increase throughput, quality, and operational efficiency.
- Provide technical leadership during critical manufacturing operations.
- Author and execute: Process Validation Master Plans (PVMP) PPQ Protocols and Reports Continued Process Verification (CPV) Programs Process Risk Assessments Media Fill Protocols
- Analyze process data and recommend improvements based on statistical and scientific principles.
- Support successful execution of PPQ campaigns.
- Support aseptic processing programs in compliance with: FDA cGMP regulations EU GMP Annex 1 ICH Guidelines USP requirements
- Participate in aseptic process simulations (APS/media fills).
- Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.
- Support contamination control and sterility assurance initiatives.
- Support qualification and implementation of: Filling lines Isolators RABS systems Lyophilizers CIP/SIP systems Sterile filtration systems Compounding equipment Visual inspection systems
- Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.
- Assess equipment performance and recommend improvements.
- Support cycle development, scale-up, and process optimization activities.
- Review thermal characterization and freeze-drying data.
- Support lyo process validation and technology transfer projects.
- Investigate cycle anomalies and process variability.
- Lead Lean Manufacturing and Operational Excellence initiatives.
- Utilize data analytics and process monitoring tools to improve performance.
- Support OEE improvement programs.
- Implement process robustness and reliability improvements.
- Support internal and external audits.
- Participate in client audits and regulatory inspections.
- Provide SME support during FDA and customer inspections.
- Prepare technical documentation for regulatory submissions when required.
- Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline
- 7+ years of pharmaceutical manufacturing experience.
- Minimum 3 years supporting aseptic manufacturing operations.
- Must be authorized to work in the U.S.
- No C2C at this time.
- Demonstrated experience with:
- Sterile injectable manufacturing
- Fill-finish operations
- GMP documentation
- Process investigations
- Technology transfer
- Process validation
- Preferred Experience in a CDMO environment.
- Experience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
- Experience with lyophilization cycle development and optimization.
- Familiarity with Annex
- of benefits.
We must preserve all substantive information; do not invent or summarize away detail. So we need to include all bullet points from the posting.
Let's extract the duties:
Under "Your Role" paragraph: "BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations. The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles."
Then subheadings with details:
Process Development & Technology Transfer:
- Lead process transfer activities from clients into BioTechnique manufacturing operations.
- Review client process documentation, batch records, process descriptions, and development reports.
- Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.
- Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.
- Support engineering runs, water runs, media fills, and demonstration batches.
Manufacturing Support:
- Provide floor support during aseptic manufacturing campaigns.
- Troubleshoot process deviations, equipment issues, yield losses, and process excursions.
- Support investigations, CAPAs, and root cause analyses.
- Drive process improvements that increase throughput, quality, and operational efficiency.
- Provide technical leadership during critical manufacturing operations.
Process Validation:
- Author and execute: Process Validation Master Plans (PVMP) PPQ Protocols and Reports Continued Process Verification (CPV) Programs Process Risk Assessments Media Fill Protocols
- Analyze process data and recommend improvements based on statistical and scientific principles.
- Support successful execution of PPQ campaigns.
Aseptic Processing Support:
- Support aseptic processing programs in compliance with: FDA cGMP regulations EU GMP Annex 1 ICH Guidelines USP requirements
- Participate in aseptic process simulations (APS/media fills).
- Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.
- Support contamination control and sterility assurance initiatives.
Equipment & Facility Engineering Support:
- Support qualification and implementation of: Filling lines Isolators RABS systems Lyophilizers CIP/SIP systems Sterile filtration systems Compounding equipment Visual inspection systems
- Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.
- Assess equipment performance and recommend improvements.
Lyophilization Support:
- Support cycle development, scale-up, and process optimization activities.
- Review thermal characterization and freeze-drying data.
- Support lyo process validation and technology transfer projects.
- Investigate cycle anomalies and process variability.
Continuous Improvement:
- Lead Lean Manufacturing and Operational Excellence initiatives.
- Utilize data analytics and process monitoring tools to improve performance.
- Support OEE improvement programs.
- Implement process robustness and reliability improvements.
Regulatory & Audit Support:
- Support internal and external audits.
- Participate in client audits and regulatory inspections.
- Provide SME support during FDA and customer inspections.
- Prepare technical documentation for regulatory submissions when required.
Now Requirements:
- Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline
- 7+ years of pharmaceutical manufacturing experience.
- Minimum 3 years supporting aseptic manufacturing operations.
- Must be authorized to work in the U.S.
- No C2C at this time.
- Demonstrated experience with:
- Sterile injectable manufacturing
- Fill-finish operations
- GMP documentation
- Process investigations
- Technology transfer
- Process validation
- Preferred Experience in a CDMO environment.
- Experience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
- Experience with lyophilization cycle development and optimization.
- Familiarity with Annex 1 contamination control requirements.
- Project management experience.
- Six Sigma Green Belt or Black Belt certification.
Benefits:
- Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
We should not include the Equal Opportunity Employment Statement (boilerplate). Also remove any duplicated lines.
Now produce HTML:
About the role
BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations. The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.
Responsibilities
Requirements
- . Similarly Requirements section with