Job DescriptionValidation Manager
I am currently recruiting a Validation Manager to work for a Global EPCM to support on the contracting business with Validation and Regulatory activity both in front end feed studies and consulting works as well as assisting operational delivery on live projects.
The role will be based in Manchester and require frequent travelling as you will be overseeing validation engineers across a range of projects across the UK.
1. Extensive knowledge of current validation requirements including:
· HVAC systems and clean rooms.
· clean utility systems
· high purity water
· pure steam systems and process gas systems.
· GMP washers and sterilisers.
· clean room equipment including LFCs, MBSCs, isolators, containment cabinets, etc.
· control system validation.
2. Knowledge of the generation of training modules and procedures for the training of site based staff.
3. Risk based approach to validation including FMEAs, SIAs, CIAs, etc.
4. Preparation of validation documentation including URSs, VMPs, Validation Plans, DQ, IQ. OQ and PQ Protocols and associated reports.
5. Knowledge of current regulatory requirements for the design of the systems
6. Experience of working with project teams in the development of compliant designs for the systems.
7. Experience of working with vendors during FAT and SAT stages including the development of compliant FAT/SAT Protocols.
8. Experience with dealing with regulatory bodies on design reviews and GMP audits to ensure accreditation of facilities is achieved first time.
9. Experience in supervising/managing small groups of validation/commissioning personnel. “Hands on” approach to management will be required.
10. Good inter-personnel skills with ability to work in a team based environment.
11. Good appearance, clean and tidy, critical when working with clients face to face.
12. Experience of working with bid teams for new projects including tender interviews with clients.
13. Validation training and academic accreditation to provide documented evidence that the applicant is suitably qualified and experienced for the position.
14. Proven knowledge of guideline documents including: EU GMP, 21CFR, ISO 14644 Parts 1 – 4, GAMP, ACDP Regulations, HTMs for autoclaves, washers, operating theatres, etc.
Previous experience in a GMP manufacturing environment would be preferred.
Please Apply for additional information.