Sr Engineer, Process
About The Position
The Sr Engineer, Process is a key technical leader supporting GMP vaccine drug substance manufacturing operations. This role provides hands-on process engineering support to ensure safe, reliable, and compliant manufacturing across upstream and downstream operations. The Senior Process Engineer is accountable for real-time troubleshooting of process and equipment issues on the manufacturing floor, driving rapid root cause identification and sustainable solutions while maintaining uninterrupted GMP operations. This position partners closely with Manufacturing, MS&T, Quality, Automation, and Facilities to support commercial manufacturing, technology transfers, process optimization, deviation investigations, and change management. The role also provides engineering ownership across the process lifecycle, including process design, scale-up, equipment specification, commissioning, qualification, and continued process verification in compliance with FDA, EMA, and global regulatory expectations.
Requirements
- Bachelor’s degree in Chemical, Biochemical, Mechanical, or related Engineering discipline; advanced degree preferred.
- Minimum of 7–10 years of progressive process engineering experience in GMP-regulated biopharmaceutical or vaccine drug substance manufacturing.
- Demonstrated hands-on experience supporting manufacturing operations, including real-time troubleshooting and floor support in a GMP environment.
- Strong working knowledge of vaccine or biologics unit operations, including upstream processing, downstream purification, formulation, CIP/SIP, and single-use technologies.
- In-depth understanding of GMP regulations, validation lifecycle, change management, deviation management, and data integrity principles.
- Proven experience with process design and engineering documentation such as PFDs, P&IDs, URS, FMEA, and equipment specifications.
- Ability to apply engineering fundamentals to complex manufacturing problems using structured root cause and risk management tools.
- Effective communicator with the ability to interface with Manufacturing, Quality, Regulatory, and senior leadership.
- Proficiency with common engineering and enterprise systems (e.g., AutoCAD, MS Office, electronic quality systems, SAP preferred).
- Ability to work in a fast-paced manufacturing environment and provide on-call or off-shift support as needed to ensure uninterrupted operations.
Responsibilities
- Provide direct, real-time process engineering support on the manufacturing floor for GMP vaccine drug substance operations, including upstream, downstream, and process support systems.
- Lead and execute troubleshooting of process and equipment deviations, collaborating with cross-functional teams to identify root causes and implement effective CAPAs.
- Serve as process owner and subject matter expert (SME) for assigned unit operations and manufacturing systems, ensuring robust and compliant operation.
- Support and lead process improvements, optimization initiatives, and capacity enhancements using data-driven and risk-based approaches.
- Author, review, and approve GMP documentation including deviations, change controls, process risk assessments, protocols, reports, and regulatory-facing technical documentation.
- Support technology transfer activities, including process characterization, equipment fit assessments, and operational readiness for new or modified processes.
- Lead or execute commissioning, qualification, and validation activities for process equipment and systems, including support of FATs, SATs, and PPQ.
- Partner with Quality Assurance to ensure alignment with Quality Systems, data integrity requirements, and regulatory commitments.
- Provide technical input during regulatory inspections and audits and present process and equipment information as a subject matter expert.
- Collaborate with vendors, contractors, and internal engineering groups to support equipment reliability, lifecycle management, and continuous improvement.
- Mentor junior engineers and contribute to engineering standards, best practices, and knowledge sharing across the site.
Benefits
- comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Senior
