Process Engineer

York, United States | Posted on 08/27/2026

Bio Technique 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. Bio Technique 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, Bio Technique 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 Bio Technique, it’s about more than just a job—it’s about your career and your future.

Bio Technique is seeking a highly motivated Process Engineer (Mid-Level to Senior-Level) 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 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.

• Lead process transfer activities from clients into Bio Technique 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
• CIP/SIP systems
• Sterile filtration systems
• 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…