About Our Client
Our client is a global leader in the life sciences industry with a strong focus on quality, innovation, and compliance. The Breda site supports critical manufacturing and packaging operations within a highly regulated GMP environment, offering engineers the opportunity to work on impactful technical projects with high standards of excellence.
About the Position
We are looking for a Commissioning, Qualification & Validation (CQV) Engineer (GMP) to support engineering and packaging-related projects. This is a hands-on role suited for an experienced CQV professional with strong knowledge of secondary packaging systems. You will work with minimal supervision and report into the Validation & Compliance function within Engineering.
Responsibilities
- Develop, update, and execute CQV documentation, including:
- Criticality Assessments
- Commissioning, Qualification & Validation Plans
- Risk Assessments
- Test Protocols (IQ/OQ/PQ)
- Requirement Traceability Matrices
- CQV Summary Reports
- Lead and execute commissioning, qualification, and validation activities on packaging systems
- Provide technical and validation guidance to project teams to ensure solutions meet internal requirements and GMP standards
- Support compliance with internal SOPs and regulatory expectations
- Contribute to additional engineering or validation tasks as assigned
Requirements
- Engineering degree or related technical qualification
- 2+ years of hands-on CQV experience in a GMP manufacturing environment
- Strong experience with secondary packaging systems, including print and inspection systems (e.g. Systech, Cognex)
- Proven experience in Computerized Systems Validation (CSV)
- Hands-on CQV execution experience within secondary packaging operations
- Solid understanding of validation documentation and how individual documents fit into the overall validation lifecycle
- Background in pharmaceutical or medical device manufacturing
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
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