My Client is a leading manufacturer of biopharmaceutical products and with a rich history of pharmaceutical development in vaccines and therapeutics they are looking for an outstanding process engineer to join their team.
The Process Engineer is the System technical expert for all Engineering Utilities systems within the GMP Envelope, and is responsible for the identification of and managing small projects relating to the utilities systems and interfacing with the wider Pharmaceutical Engineering group to ensure Utilities systems within the GMP envelope remain compliant with
current Good Manufacturing Practice.
Roles and Responsibilities
To monitor Utilities equipment trend data as provided by the computerised maintenance management system and liaison with the maintenance teams/users, to recommend and manage process improvements/initiatives and when required prepare justifications for submission within the appropriate capital budget.
Project Manage small business critical GMP projects as delegated by the Process Engineering Manager in accordance with the GMP Capital Project procedure.
Represent the Engineering function at BSI, MHRA and FDA audits as subject matter expert for Utilities supported by the Process Engineering Manager.
To be responsible for the writing, and review of User Requirement specifications, SOP’s, and generation of design documentation related to Utilities systems and other equipment within the GMP envelope.
Review and Approval of Engineering technical regulatory documents as required to support the Engineering function including review and approval of Safety related documents such as pressure systems written schemes of examination.
For more information please contact Robert Frame on: 0161 504 8058 or firstname.lastname@example.org