Project Validation Engineer

Cheshire
4 week notice
£60-70 p/hour
Inside or Outside IR35

An effective Project Manager and Engineer with 33 years of broad based practical Engineering, Validation and Manufacturing experience incorporating Project Management, Validation, Lean Manufacturing techniques, complimented by time served Mechanical Engineering qualifications.

His Business, Project, Validation, Engineering and Manufacturing background has been developed through working across a number of disciplines and aspects within the respective businesses. This has given him the financial, engineering, manufacturing, commercial skills and experience supported by a strong results oriented leadership style with hands on teambuilding skills which has characterised the nature of his success.

Recent deliverables:

Supporting Change Control requirements for Validation.
• Supporting the site in all of its Audits (Internal and External).
• Reviewing and approving the Validation Protocols for others as part of the approval system and GMP practices.
• Preparation and execution of the VMP’s and VSR’s for the below Projects.
• Preparation and execution of IQ, OQ & PQ Protocols and Reports for the relocation / transfer of four manufacturing processes from the satellite manufacturing facility.
• Preparation and execution of IQ, OQ & PQ Protocols and Reports on the 10 Filling Lines.
• Preparation and execution of IQ, OQ & PQ Protocols and Reports on the 10 End of Line Packaging (Labeller, Vision System & Pick & Place Robot).
• Supported the qualification of the four cleanrooms that house the machines and the QC lab and its off the shelf equipment (Fridges, Temperature Controlled Walk-In rooms, Incubators, Laminar Airflow Units & Specific Test Equipment)
• Support and Witness the Cleanroom Qualifications of five ISO5 Cleanrooms.