Validation Manager

Adepto Technical
Manchester, UK
13 Oct 2019
26 Oct 2019
Contract Type
Full Time
Validation Manager - Pharma EPCM Business - Permanent - North West based with travel

Our client is a leading EPCM business specialising in Life Science and Highly Regulated industries. At present they are seeking a Validation Manager on a permanent basis. The position will be based from their North West office and will include regular travel to clients sites within the UK and Europe.
The role will support Validation and Regulatory activities both in front end feed studies and consulting works as well as assisting operational delivery on live projects. Candidates will be responsible for;

Extensive knowledge of current validation requirements including:
• HVAC systems and clean rooms.
• Clean Utility systems
• Purified 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.

Knowledge of the generation of training modules and procedures for the training of site based staff.
Risk based approach to validation including FMEAs, SIAs, CIAs, etc.
Preparation of validation documentation including URSs, VMPs, Validation Plans, DQ, IQ. OQ and PQ Protocols and associated reports.
Knowledge of current regulatory requirements for the design of the systems
Experience of working with project teams in the development of compliant designs
Experience of working with vendors during FAT and SAT stages including the development of compliant FAT/SAT Protocols.
Experience with dealing with regulatory bodies on design reviews and GMP audits to ensure accreditation of facilities is achieved first time.
Experience in supervising/managing small groups of validation/commissioning personnel. "Hands on" approach to management will be required.
Good inter-personnel skills with ability to work in a team based environment.
Experience of working with bid teams for new projects including tender interviews with clients.
Proven knowledge of guideline documents including: EU GMP, 21CFR, ISO 14644 Parts 1 - 4, GAMP, ACDP Regulations, HTMs for autoclaves, washers, operating theatres, etc

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