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Commissioning Qualification Validation Engineer (GMP)
The CQV Engineer will support technical projects under minimal supervision and will report to Sr Manager Validation& Compliance within the site Engineering organization. The CQV Engineer will demonstrate hands on commissioning/qualification skills, including but not limited to the following: develop, implement and report test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures. The CQV Engineer will drive the development of system commissioning qualification and validation documentation.
Job
Documentation
- Develop and Update several Validation documents. E.g. System Level Criticality Assessments, Validation, Commissioning, Qualification plans, Risk assessments, Test Protocols, Requirement traceability matrixes Commissioning, Qualification and Validation summary report
Testing
- Lead Commissioning, Qualification and Validation activities
Technical support
- Deliver guidance to the project group, so the implement technical solution follows the validation plan in order to achieve meeting internal customer requirements, and accordance with Amgen SOPS
Profile
Basic Qualifications & Experience:
- Experienced with Secondary Packaging Systems, including experience with Print and Inspection systems (e.g. Systech, Cognex)
- At least 3 years’ experience in executing Commissioning, Qualification and Validation within manufacturing organizations in the pharmaceutical industries.
- Experienced in Computerized Systems Validation
- Hands on commissioning and qualification experience within Secondary Packaging Operations.
- Good understanding of the role of a single document within the bigger picture.
- Internal and /or external reporting relationships.
Preferred Qualifications & Experience:
- Ability to work independently and remotely with minimum direct supervision
- Good English Technical Writing
- Excellent communication skills
- Customer relationship management skills
- Critical thinking skills
- Able to set clear priorities and escalate to ensure timely delivery of the project phases including design, development, implementation, testing, construction, commissioning, and validation.
- Experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling.
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise.
