Sr Engineer, Process
Emergent BioSolutions
August 17, 2026
On-site
Canton, MA
Operations
Essential Functions:
- Provide direct, real-time process engineering support on the manufacturing floor for GMP vaccine drug substance operations (upstream, downstream, and process support systems).
- Lead troubleshooting of process and equipment deviations; identify root causes and implement effective CAPAs.
- Serve as process owner/SME for assigned unit operations and manufacturing systems to ensure robust, compliant operation.
- Support process improvements, optimization, and capacity enhancements using data-driven, risk-based approaches.
- Author/review/approve GMP documentation (deviations, change controls, process risk assessments, protocols, reports, and regulatory-facing technical documentation).
- Support technology transfer (process characterization, equipment fit assessments, operational readiness).
- Lead/execute commissioning, qualification, and validation (FATs, SATs, PPQ) for process equipment and systems.
- Partner with Quality Assurance on Quality Systems, data integrity requirements, and regulatory commitments.
- Provide technical input during regulatory inspections/audits as SME.
- Collaborate with vendors/contractors/internal engineering for equipment reliability, lifecycle management, and continuous improvement.
- Mentor junior engineers and contribute to engineering standards and best practices.
Minimum Qualifications:
- BS in Chemical/Biochemical/Mechanical (or related) Engineering; advanced degree preferred.
- 7–10+ years process engineering experience in GMP-regulated biopharmaceutical/vaccine drug substance manufacturing.
- Hands-on GMP floor support and real-time troubleshooting experience.
- Strong knowledge of vaccine/biologics unit operations (upstream, downstream, formulation, CIP/SIP, single-use).
- Deep understanding of GMP, validation lifecycle, change/deviation management, and data integrity.
- Experience with process design/documentation (PFDs, P&IDs, URS, FMEA, equipment specs).
- Ability to use structured root-cause and risk tools; strong communication across functions.
- Proficiency with AutoCAD, MS Office, electronic quality systems; SAP preferred.
- Ability to provide on-call/off-shift support.
Compensation/Benefits:
- Estimated base salary: $129,000–$156,000 (plus possible incentive compensation).
- Comprehensive benefits package (details via company site).
Application Instructions:
- If selected for an interview, speak with an HR Partner about compensation philosophy and available benefits.
- Provide direct, real-time process engineering support on the manufacturing floor for GMP vaccine drug substance operations (upstream, downstream, and process support systems).
- Lead troubleshooting of process and equipment deviations; identify root causes and implement effective CAPAs.
- Serve as process owner/SME for assigned unit operations and manufacturing systems to ensure robust, compliant operation.
- Support process improvements, optimization, and capacity enhancements using data-driven, risk-based approaches.
- Author/review/approve GMP documentation (deviations, change controls, process risk assessments, protocols, reports, and regulatory-facing technical documentation).
- Support technology transfer (process characterization, equipment fit assessments, operational readiness).
- Lead/execute commissioning, qualification, and validation (FATs, SATs, PPQ) for process equipment and systems.
- Partner with Quality Assurance on Quality Systems, data integrity requirements, and regulatory commitments.
- Provide technical input during regulatory inspections/audits as SME.
- Collaborate with vendors/contractors/internal engineering for equipment reliability, lifecycle management, and continuous improvement.
- Mentor junior engineers and contribute to engineering standards and best practices.
Minimum Qualifications:
- BS in Chemical/Biochemical/Mechanical (or related) Engineering; advanced degree preferred.
- 7–10+ years process engineering experience in GMP-regulated biopharmaceutical/vaccine drug substance manufacturing.
- Hands-on GMP floor support and real-time troubleshooting experience.
- Strong knowledge of vaccine/biologics unit operations (upstream, downstream, formulation, CIP/SIP, single-use).
- Deep understanding of GMP, validation lifecycle, change/deviation management, and data integrity.
- Experience with process design/documentation (PFDs, P&IDs, URS, FMEA, equipment specs).
- Ability to use structured root-cause and risk tools; strong communication across functions.
- Proficiency with AutoCAD, MS Office, electronic quality systems; SAP preferred.
- Ability to provide on-call/off-shift support.
Compensation/Benefits:
- Estimated base salary: $129,000–$156,000 (plus possible incentive compensation).
- Comprehensive benefits package (details via company site).
Application Instructions:
- If selected for an interview, speak with an HR Partner about compensation philosophy and available benefits.