1. 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
What will be the interview process?

30 minutes
Certifications Required

None

Requirements

Doctorate OR -Masters + 2 years of Engineering experience OR
Bachelors in Engineering + 4 years of Engineering experience.

Erforderliche Kompetenzen

Commissioning & Qualification (C&Q) Strategy and PlanningRisk Assessment using ISPE Baseline and ASTM E2500Development of C&Q Plans, Schedules, and Resource ForecastingFactory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and Field CommissioningIQ/OQ/PQ Protocol Authoring, Review and ExecutionRequirements Traceability (URS to testing)GxP and Regulatory Compliance (GMP, FDA, EMA)Electronic Document Management and Document Lifecycle ControlData Integrity and ALCOA+ PrinciplesChange Control, Deviation Assessment and CAPA ManagementCross-functional Collaboration and Stakeholder CommunicationTechnical Mentorship and Team GuidanceVendor and Contractor Coordination during Startup ActivitiesCharacterization Protocol Development, Execution and Reporting

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