Company
We are looking for candidates for a site engineering team supporting pharmaceutical technical projects within a regulated GMP environment.
Job Description
This role is for a CQV Commissioning Qualification Validation Engineer (GMP). The engineer will support technical projects with minimal supervision and report to the Senior Manager Validation & Compliance. You will take a hands-on approach to commissioning and qualification activities, develop and execute test strategies, and drive the creation of system commissioning qualification and validation documentation.
Responsibilities
- Develop and update validation documentation, including system-level criticality assessments, validation and commissioning/qualification plans, risk assessments, test protocols, and requirement traceability matrices
- Prepare and maintain commissioning, qualification, and validation summary reports
- Lead commissioning, qualification, and validation activities for technical solutions
- Provide technical guidance to project teams to ensure implemented solutions follow the validation plan and meet internal customer requirements
- Support delivery in line with established site procedures (SOPs)
- Carry out additional tasks or projects as requested by your supervisor
Requirements
- At least 3 years of experience executing commissioning, qualification, and validation within pharmaceutical manufacturing
- Hands-on commissioning and qualification experience in secondary packaging operations
- Experience with secondary packaging systems, including print and inspection systems (e.g. Systech, Cognex)
- Experience in Computerized Systems Validation
- Strong understanding of how single documents fit into the broader validation picture
- Ability to work with internal and/or external reporting relationships
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58235
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Jyothi Shiva
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