PB
Process Validation Engineer
Accepting applicationsPSC Biotech® Corporation · York, PA
Full-Time Mid_senior Sicaiarmasicate
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.
The Experience
With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring an experienced Process Validation Engineer to join our team! The Process Validation Engineer is responsible for leading the implementation, startup, qualification, and validation of sterile injectable manufacturing processes and equipment. This role supports new product introductions and tech transfer activities by developing and executing robust process validation strategies, engineering studies, and risk-based verification in compliance with GMP and regulatory requirements.
Lead implementation, startup, and qualification of sterile injectable manufacturing equipment including filling lines, isolators/RABS, lyophilizers, filtration systems, and process skids.
Develop and review engineering documentation including URS, FDS, P&IDs, commissioning plans, IQ/OQ/PQ protocols, and validation reports.
Execute engineering studies, DOE activities, and process characterization to establish robust process parameters and operational design spaces.
Support tech transfer and New Product Introduction (NPI) activities for biologics, vaccines, and sterile injectable products.
Perform system risk assessments, FMEA analyses, and ASTM E2500-based verification activities for GMP-critical systems.
Drive contamination control strategy (CCS), environmental monitoring integration, and Annex 1 compliance initiatives.
Collaborate cross-functionally with Quality, Manufacturing, Validation, Automation, and external vendors to ensure inspection readiness and successful commercial startup.
Requirements
Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related discipline.
5+ years of experience in sterile pharmaceutical, biotech, or cGMP-regulated manufacturing environments.
Strong knowledge of aseptic processing, lyophilization, sterile filtration, CQV, and process validation lifecycle principles.
Experience with ASTM E2500, ISPE Baseline Guide Volume 5, FDA cGMPs, and EU Annex 1 requirements.
Proficiency with engineering studies, statistical analysis tools, and root cause investigations.
Preffered experience supporting sterile injectable or biologics CDMO/CRDMO operations.
Strong leadership, technical writing, and cross-functional communication skills.
Ability to manage complex startup activities and support regulatory inspections and audits.
Must be authorized to work in the U.S
No C2C at this time.
Benefits
Offering a full suite of benefits, BioTechnique™ 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 - BioTechnique 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
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Equal Opportunity Employment Statement
BioTechnique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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The Experience
With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At BioTechnique, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring an experienced Process Validation Engineer to join our team! The Process Validation Engineer is responsible for leading the implementation, startup, qualification, and validation of sterile injectable manufacturing processes and equipment. This role supports new product introductions and tech transfer activities by developing and executing robust process validation strategies, engineering studies, and risk-based verification in compliance with GMP and regulatory requirements.
Lead implementation, startup, and qualification of sterile injectable manufacturing equipment including filling lines, isolators/RABS, lyophilizers, filtration systems, and process skids.
Develop and review engineering documentation including URS, FDS, P&IDs, commissioning plans, IQ/OQ/PQ protocols, and validation reports.
Execute engineering studies, DOE activities, and process characterization to establish robust process parameters and operational design spaces.
Support tech transfer and New Product Introduction (NPI) activities for biologics, vaccines, and sterile injectable products.
Perform system risk assessments, FMEA analyses, and ASTM E2500-based verification activities for GMP-critical systems.
Drive contamination control strategy (CCS), environmental monitoring integration, and Annex 1 compliance initiatives.
Collaborate cross-functionally with Quality, Manufacturing, Validation, Automation, and external vendors to ensure inspection readiness and successful commercial startup.
Requirements
Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related discipline.
5+ years of experience in sterile pharmaceutical, biotech, or cGMP-regulated manufacturing environments.
Strong knowledge of aseptic processing, lyophilization, sterile filtration, CQV, and process validation lifecycle principles.
Experience with ASTM E2500, ISPE Baseline Guide Volume 5, FDA cGMPs, and EU Annex 1 requirements.
Proficiency with engineering studies, statistical analysis tools, and root cause investigations.
Preffered experience supporting sterile injectable or biologics CDMO/CRDMO operations.
Strong leadership, technical writing, and cross-functional communication skills.
Ability to manage complex startup activities and support regulatory inspections and audits.
Must be authorized to work in the U.S
No C2C at this time.
Benefits
Offering a full suite of benefits, BioTechnique™ 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 - BioTechnique 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
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Equal Opportunity Employment Statement
BioTechnique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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