Process Validation Engineer

PSC Biotech • York, PA

1d

About The Position

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.

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.

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.
• 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.

Nice To Haves

• Preffered experience supporting sterile injectable or biologics CDMO/CRDMO operations.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior