Sr Engineer, Validation
Emergent BioSolutions
August 11, 2026
On-site
Canton, MA
Operations
Job Summary
- Ensure cGMP regulatory compliance by adhering to site and corporate validation plans, policies, and procedures.
- Provide accountability/oversight for the validation program and validation projects; lead innovation.
- Independently execute multi-faceted projects (Capital, Client, Overhead) and manage multiple priorities.
- Serve as Subject Matter Expert (SME) across validation disciplines: Commissioning & Qualification, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation.
- Provide leadership and technical guidance to implement best practices and improve team performance.
Responsibilities (Essential/Technical/Leadership)
- Create and execute CX/IQ/OQ/PQ commissioning, qualification, and validation protocols/plans; identify and resolve non-conformances.
- Provide commissioning/qualification guidance and strategy during project planning.
- Review/approve system lifecycle documentation and department deliverables.
- Perform/oversee equipment, aseptic processing, steam sterilization, and process validation and control systems.
- Investigate CAPAs/deviations and implement corrective actions.
- Plan/coordinate/execute projects using project management methodologies.
- Participate in regulatory inspections; represent Validation on teams/committees and at conferences; report status to leadership.
Problem Solving
- Propose solutions to complex problems; own troubleshooting, RCA, and risk assessment.
- Use monitoring and problem-solving tools (e.g., SPC, DMAIC).
Qualifications / Required Skills
- BS in Engineering/Chemistry/Microbiology (or related) and/or 8+ years industrial experience in system qualification/validation.
- Expert validation knowledge; strong understanding of ISPE, EU, and 21 CFR 210/211 and Part 11.
- Experience with CIP, SIP, autoclaves, temperature-controlled units, critical utilities, facilities, equipment, and computer/control systems in GMP settings.
- Proficient with Microsoft (Word/Excel/PowerPoint) and Kaye AVS; strong technical writing and communication.
- Ability to read/interpret PFDs, P&IDs, and electrical schematics; independent and collaborative in a fast-paced environment.
- Ensure cGMP regulatory compliance by adhering to site and corporate validation plans, policies, and procedures.
- Provide accountability/oversight for the validation program and validation projects; lead innovation.
- Independently execute multi-faceted projects (Capital, Client, Overhead) and manage multiple priorities.
- Serve as Subject Matter Expert (SME) across validation disciplines: Commissioning & Qualification, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation.
- Provide leadership and technical guidance to implement best practices and improve team performance.
Responsibilities (Essential/Technical/Leadership)
- Create and execute CX/IQ/OQ/PQ commissioning, qualification, and validation protocols/plans; identify and resolve non-conformances.
- Provide commissioning/qualification guidance and strategy during project planning.
- Review/approve system lifecycle documentation and department deliverables.
- Perform/oversee equipment, aseptic processing, steam sterilization, and process validation and control systems.
- Investigate CAPAs/deviations and implement corrective actions.
- Plan/coordinate/execute projects using project management methodologies.
- Participate in regulatory inspections; represent Validation on teams/committees and at conferences; report status to leadership.
Problem Solving
- Propose solutions to complex problems; own troubleshooting, RCA, and risk assessment.
- Use monitoring and problem-solving tools (e.g., SPC, DMAIC).
Qualifications / Required Skills
- BS in Engineering/Chemistry/Microbiology (or related) and/or 8+ years industrial experience in system qualification/validation.
- Expert validation knowledge; strong understanding of ISPE, EU, and 21 CFR 210/211 and Part 11.
- Experience with CIP, SIP, autoclaves, temperature-controlled units, critical utilities, facilities, equipment, and computer/control systems in GMP settings.
- Proficient with Microsoft (Word/Excel/PowerPoint) and Kaye AVS; strong technical writing and communication.
- Ability to read/interpret PFDs, P&IDs, and electrical schematics; independent and collaborative in a fast-paced environment.