CQV Engineer - Commissioning Qualification Validation Engineer

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.

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 reports

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 companies SOPS

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.
• Preferably experience within a GMP compliance environment regarding practices, policies, procedures, legal requirements and goals of project, develop supporting documentation and monitor activity timeliness / scheduling.

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