Position SummaryThe
Senior Engineer is responsible for leading and executing commissioning, qualification, and characterization activities for manufacturing, utility, facility, and laboratory systems within a regulated pharmaceutical/biotechnology environment. This role ensures compliance with GMP regulations, FDA, EMA, and internal quality standards while supporting project execution, system startup, validation, and lifecycle management of qualified systems.
The Senior Engineer will collaborate cross-functionally with Engineering, Quality, Manufacturing, Validation, Supply Chain, and external vendors to ensure systems are designed, installed, tested, and operated in accordance with approved requirements and industry best practices.
Key Responsibilities1. C&Q Strategy & Planning
- Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
- Define system boundaries and identify direct/indirect impact systems.
- Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
- Develop C&Q plans, schedules, and resource forecasting.
2. Commissioning Activities
- Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
- Ensure systems are installed and operate per design specifications.
- Coordinate with vendors and contractors during startup activities.
- Review and approve commissioning documentation and test results.
3. Qualification Execution (IQ/OQ/PQ)
- Author, review, and approve qualification protocols (IQ, OQ, PQ).
- Ensure traceability from User Requirements Specifications (URS) through testing.
- Execute or oversee protocol execution and ensure proper documentation of results.
4. Documentation & Compliance
- Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.
- Maintain document lifecycle within electronic systems.
- Support data integrity and ALCOA+ principles throughout qualification activities.
- Prepare and support validation summary reports.
5. Risk Management & Change Control
- Lead and document risk assessments related to system qualification.
- Evaluate and manage change controls impacting validated systems.
- Assess impact of deviations and implement corrective and preventive actions (CAPA).
6. Cross-functional Coordination
- Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
- Interface with system owners and technical authorities.
- Provide technical guidance and mentorship to junior engineers and project team members.
- Support project meetings, status reporting, and stakeholder communication.
7. Characterization Process
- Develop the characterization protocols.
- Execute the characterization activities.
- Develop and review the characterization reports
Minimum QualificationsEducation & Experience:- Doctorate Degree in Engineering or a related technical field, OR
- Master's Degree in Engineering with 2+ years of directly related Engineering experience, OR
- Bachelor's Degree in Engineering with 4+ years of directly related Engineering experience
Preferred Qualifications- Experience within the pharmaceutical, biotechnology, medical device, or highly regulated manufacturing industry.
- Strong knowledge of GMP regulations, FDA requirements, EMA guidelines, and industry best practices.
- Experience with commissioning and qualification of process equipment, utilities, cleanrooms, and manufacturing systems.
- Knowledge of ISPE Baseline Guides, ASTM E2500, risk management methodologies, and validation lifecycle concepts.
- Experience authoring and reviewing IQ/OQ/PQ protocols and validation documentation.
- Familiarity with electronic document management and quality systems.
- Strong problem-solving, project management, and technical writing skills.
- Excellent communication and stakeholder management abilities.
