Our expanding biopharma client who develops and manufactures vaccines and therapeutics are seeking technical expert with a background in facilitates, equipment, GMP Utilities, design, validation and validation.
The engineering group is responsible for provision of all engineering support. This structure includes engineering functions provided by engineers specialising in clean rooms, GMP critical utilities, production equipment, pharmaceutical facilities, and capital works delivery.
The Process Engineer is the SME for all GMP Engineering Utilities systems, and is responsible for projects relating to utilities systems and to ensure Utilities systems remain GMP compliant.
MAIN DUTIES AND RESPONSIBILITIES
* To monitor Utilities equipment trend data and to recommend and manage process improvements/ initiatives.
* Assist in providing technical guidance and training to the wider engineering team and administering business process related tasks through the computerised maintenance management system.
* Represent the Engineering function at BSI, MHRA and FDA audits as subject matter expert for Utilities.
* To write 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.
* Responsible for troubleshooting to establish the root cause, develop and manage appropriate corrective action plans and report through the Company non conformance system, for failures/ performance issues.
* Represent Engineering on capital projects.
* Masters Degree in Process or Chemical Engineering. Ideally Chartered Engineer Status.
* Extensive experience in an Engineering operational and design role in the Pharmaceutical Industry.
* Experience of Successfully leading a variety of major specialist engineering initiatives
* Experience of Regulatory Audits - FDA & MHRA
* Experience in Preparing Detailed GMP Engineering Technical Documentation
* Extensive pharmaceutical industry experience of facilities, equipment and GMP Critical Utilities operation, design, commissioning and validation.
* Experience of working within a GMP Quality System, in particular, change control, Non Conformance management, CAPA, discrepancy/deviation, and documentation management.
* Specific knowledge of FDA and MHRA regulatory requirements (i.e US 21 Code of Federal Regulations parts 210 and 211; Eudralex Volume 4 part 1 Annexe 1)
* Experience of current available engineering/equipment technology and its subsequent sizing/selection to support Pharmaceutical Operations
* Experience of the design and control of capital project design documentation within a GMP environment.
* Experience of project management of capital project delivery within a pharmaceutical manufacturing environment.
* Specialist knowledge of Biopharma GMP Manufacturing processes, associated equipment technologies and design
* Working knowledge of pharmaceutical facility design and construction and comprehensive understanding of the underlying engineering principals
* Knowledge and Operation of Computerised Maintenance Management Systems (Maximo)
Job Title: Process Engineer
Reference No: 238514
Job Type: Permanent
Salary: c£40,000 plus generous benefits
- process engineering
- chartered engineer
- chemical engineer
- clean rooms
- capital project
- pharmaceutical facilities