Highly skilled CQV Engineer sought by our client in Berne for a pharma/biotech company.
Job Details
Location: Berne
Contract Type: Limited contract
Duration: 1 year
Key Responsibilities
* Oversee commissioning and qualification processes to meet project deadlines.
* Develop, execute, and obtain approval for Design Qualification (DQ), including release for Installation Qualification (IQ).
* Manage commissioning activities, supervising vendors to ensure high-quality testing and scope compliance.
* Prepare, execute, and approve Installation & Operational Qualification (IQ/OQ), ensuring release for Operational Qualification (OPS).
* Support the execution of Design Qualification for other critical systems.
* Maintain oversight of activities and schedules related to relevant systems.
* Contribute to project deliverables and development, reporting on key milestones.
* Identify and assist in resolving project issues, tracking non-conformance records.
* Evaluate project risks and assess the effectiveness of mitigation strategies.
Requirements
* Degree in Life Sciences or Engineering.
* Minimum 4 years of experience in commissioning/qualification/validation activities in pharmaceutical/biotech environment.
* Good knowledge of cGMP and regulatory requirements.
* Fluency in English and German.