Senior Validation Engineer
- France
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client, a global biotechnology organisation, is recruiting for a Senior Validation Engineer to join their capital project in the South of France. This new build facility will house a therapeutic protein production plant, and we are looking for a Senior Validation Engineer to help expand our client's biotech operations throughout Europe. As the Senior Validation Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.
Responsibilities and Requirements:
- Support the generation and/or review of key deliverables including User Requirements Specifications, System Impact Assessments, Criticality Assessments, Data Integrity Assessments, Design Qualification, Requirements Traceability Matrices, Commissioning, IQ, OQ and PQ protocols for Analytical Equipment
- Collaborate with multi-disciplinary team : external partners, consultants, Quality Control, Manufacturing, Process Engineers, E&HS, Quality
- Assure that the schedule of generation of CQV documentation is on track
- Support the execution of the CQV activities including commissioning, IQ, OQ and PQ
- Contribute to Validation deviation resolution including troubleshooting and root cause analysis
- Perform Periodic Review and Requalification of qualified equipment, systems, and utilities to ensure system remains suitable for its intended use and to verify compliance with appropriate industry regulations and company policies
- Support the development of the qualification and validation programs at Just
- Develop phase appropriate ways to comply with regulatory requirements
- Support inspection readiness activities, and support corrective actions based on audit findings
- Support implementation of CMMS (Computerized Maintenance Management System)
- Support Document Control Management activities (electronic storage architecture, levels of rights…)
If this role is of interest to you, please apply now!
#LI-CO1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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