Description
A global Biopharmaceutical leader is currently looking for an experienced CQV Engineer to join their team in Denmark.Key Responsibilities of the CQV Engineer will include:
- Utensil/Parts washer and dry heat sterilisation activities.
- Typically, you will own a specific piece of equipment, for which you will be responsible during the project phases from specification until IQ/OQ, through to PQ. Examples of equipment are autoclaves, CPEs, dry sterilisers, VHPs, etc.
- Responsible for Site Acceptance Testing (SAT), Installation & Operational Qualification (IQ/OQ), and Process Qualification (PQ).
- Perform review of CQV protocols at each stage of the validation life cycle from design and risk assessment through to qualification and validation.
- Provide up to date information to Line Management on activities and time lines relating to validation work, utilising appropriate techniques.
- Degree or equivalent in an Engineering based subject or related experience in an Equipment/Validation role.
- Experience within Biotech/pharmaceutical Manufacturing environments with a specific background in Biologics.
- Prior experience with manufacturing equipment such as Utensil/Parts washers and Sterilisation/Autoclaves/VHP (Dry heat).
- Solid experience of project life cycle activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
- Demonstrable experience in drafting, executing and reporting of documentation ie IQ, OQ, PQ protocols.