Description
A Pharmaceutical contract manufacturer currently has a contract requirement for an experienced Validation Engineer, with both process equipment and utilities experienceWorking on a 6 months + contract, you will be required to carry out the generation, execution and review of all life cycle validation documentation for the qualification of process equipment and utilities within a highly regulated Biopharmaceutical manufacturing environment.
This will involve Re-qualification of existing equipment and processes, in line with external audits and subsequent process validation activities, as part of a continuous improvement programme.
Key Responsibilities:
- Write and review process validation protocols and reports for new and existing equipment. Biologics manufacturing equipment to include: autoclaves, Oxidisation Sterilsation, HVAC, Vessels, Secondary/Packaging and CIP/SIP processes.
- Review/produce supporting validation documentation, as required, as part of a validation exercise.
- Undertake process and cleaning validation exercises and/or the supervision of these exercises.
- Co-ordinate with other groups with responsibilities for process/cleaning validation activities directly related to validation, e.g. Project Engineering.
- Provide up to date information to Line Management on activities and time lines relating to validation work, utilising appropriate techniques.
Ideal Skills and Experience:
- Degree or HNC/D qualified in an Engineering based subject or related experience in an Equipment/Process/Utilities Validation role.
- Experience within Biopharmaceutical Manufacturing environments with a specific background in Biologics manufacturing equipment to include: autoclaves, Oxidisation Sterilsation, HVAC, Vessels, Secondary/Packaging and CIP/SIP processes.
- Solid experience of project lifecycle 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.