Senior C&Q Engineer
About The Position
For C&Q services in the Engineering area. This role involves developing and implementing the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. The engineer will develop C&Q plans, schedules, and resource forecasts, oversee and/or execute commissioning activities including FAT, SAT, and field commissioning, and ensure systems are installed and operate per design specifications. Responsibilities also include coordinating with vendors and contractors, reviewing and approving commissioning documentation and test results, and authoring, reviewing, and approving qualification protocols (IQ, OQ, PQ). The role ensures traceability from User Requirements Specifications (URS) through testing, executes or oversees protocol execution, and ensures proper documentation of results. Compliance with GMP, FDA, EMA, and internal Amgen standards is critical, as is maintaining document lifecycle within electronic systems and supporting data integrity and ALCOA+ principles. The engineer will prepare and support validation summary reports, lead and document risk assessments, evaluate and manage change controls, and assess impact of deviations and implement CAPA. Additionally, the role involves developing and executing characterization protocols and reports, collaborating with various internal teams, interfacing with system owners, providing technical guidance to junior engineers, and supporting project meetings and communication.
Requirements
- Bachelor's Degree in Engineering
- Four (4) years of Assembly and Packaging Process experience
- Bilingual (English & Spanish)
- Project Management skills
- C&Q Strategy & Planning experience
- Commissioning Activities experience
- Qualification Execution (IQ/OQ/PQ) experience
- Documentation & Compliance experience
- Cross-functional Coordination experience
Responsibilities
- Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
- Develop C&Q plans, schedules, and resource forecasting.
- 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.
- 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.
- 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.
- 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).
- Develop the characterization protocols.
- Execute the characterization activities.
- Develop and review the characterization reports.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
