CW Commissioning Qualification Validation Engineer (GMP)
The CQV Engineer will support technical projects under minimal supervision and will report to Validation Manager of Site engineering.
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.
- Develop and Update several Validation documents.
- System Level Criticality Assessments,
- Commissioning, Qualification and Validation plans,
- Risk assessments,
- Protocols and reports,
- Requirement traceability matrices
- Commissioning, Qualification and Validation summary reports
- Lead Commissioning activities, Qualification activities 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
• Any other tasks/projects assigned as per supervisor request.
Basic Qualifications & Experience:
- Experienced with Secondary Packaging Systems, including experience with Print and Inspection systems (e.g., Systech, Cognex)
- At least 5 years’ experience in executing Commissioning, Qualification and Validation within manufacturing organizations in the pharmaceutical industries.
- Experienced in Computerized Systems Validation
- Basic knowledge of Paperless validation systems (HP ALM/ KNEAT)
- 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 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.