Description
Senior Validation Engineer - AutoclavesThe Senior Validation Engineer will be required for an initial 6 month contract to be responsible for the management of the qualification of Autoclaves within a highly regulated Biopharmaceutical manufacturing environment during a significant period of projects.
Key Responsibilities:
- Project manage the validation activities within an aseptic/sterile environment taking responsibility for creating specific equipment validation strategies.
- Undertake validation exercises on Autoclaves within a sterile/aseptic biopharmaceutical environment.
- Co-ordinate with other groups with responsibilities for validation activities directly related to validation, eg Project Engineering.
- Provide up to date information to Line Management on activities and time lines relating to validation work, utilising appropriate techniques.
- Review/produce supporting validation documentation, as required, as part of a validation exercise. (IQ/OQ/PQ)
- Write and review validation protocols and reports for new and existing equipment.
- Degree qualified in Engineering based subject or related experience in a Validation/Qualification role.
- Experience within Biopharmaceutical Manufacturing environments with an understanding of Biologics manufacturing equipment to include Autoclaves.
- Solid experience of project life cycle validation activities to include the qualification of equipment in conjunction with Project engineering/CAPEX teams.
- Demonstrable experience in drafting, executing and reporting of validation documentation ie. IQ, OQ, PQ protocols.
- Experience of working alongside regulatory auditors, liaising with FDA and/or MHRA investigators during audits.
- Ability to train and operate within a sterile manufacturing facility to include aseptic filling areas.