Commissioning Engineer
Talentmark
Role description
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.
Key Responsibilities
Documentation:- Develop and update several Validation documents (System Level Criticality Assessments, Validation, Commissioning, Qualification plans, Risk assessments, Test Protocols, Requirement traceability matrixes, Commissioning, Qualification and Validation summary reports)
Qualifications & Experience
- Experienced with secondary packaging systems, including 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 industry.
- Experienced in Computerized Systems Validation.
- Hands‑on commissioning and qualification experience within secondary packaging operations.
- Ability to work independently and remotely with minimum direct supervision (a plus).
- Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays and problems by utilizing technical and business expertise (a plus).
Interested in this opportunity? Please respond via this page!
Seniority level
- Associate
Employment type
- Full-time
Job function
- Biotechnology Research and Pharmaceutical Manufacturing
