CQV Engineer – Supporting systems (autoclaves & parts washers)
Bio pharmaceutical company require an experienced CQV Engineer who will be responsible for the delivery of the Commissioning, Qualification and Validation activities for supporting systems (Autoclaves and parts washers) on a complex Fill Finish manufacturing expansion project based in Denmark.
The requirement will be for initially 12 months with the view to extend beyond that point.
The successful CQV Engineer will be responsible for:
- Support the commissioning, qualification and validation of all supporting systems for a greenfield fill finish/drug product project. Including but not limited to; Autoclaves & parts washers.
- Review vendor documents to support commissioning and qualification requirements.
- Completes the development, review, and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
- Ensures validation non-conformances or deviations are minimised during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
- Supervise vendors/ contractors on site during commissioning activities.
- Ensuring compliance with current industry regulations and guidelines relating to validation.
- Support department performance against defined KPIs.
- Encourage actively the culture of teamwork and integration within the Project matrix organisation, and with all other Departments.
- Participate fully in cross-functional training initiatives
- Ensure timely completion of all SOP, reading, training and assessments
- Other duties as required and directed by the Project Manager or CQV Lead.
- At least 5 years commissioning, qualification, and validation (CQV) experience within a complex project environment.
- Extensive understanding and knowledge of Supporting systems including but not limited to Autoclaves and parts washers.
- Ideally, this individual would have worked as part of a matrix organisation to deliver start-up projects.
- Knowledge of validation practices and regulatory guidelines for a biopharma/pharmaceutical facility.
- Experience with regulatory audits, in particular representing equipment qualification type issues.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
QAV Specialist – Fill Finish – Denmark – 12 month contract Biopharmaceutical company require QAV Specialists to manage the Quality Engineering activities on a substantial biotechnology
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