Process Engineer - Wiltshire - £50/hr

Recruiter
Optimus Search Limited
Location
Wiltshire, UK
Salary
Competitive
Posted
19 Jul 2019
Closes
02 Sep 2019
Ref
1213191178
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Are you a Process Engineer interested in working for one of the leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!

Title: Process Engineer

Rate: Negotiable

Location: South West England

Positions Available: 1 Engineer

Type: Contract (6 Months rolling)

A Fantastic new role has just opened up at one of our leading UK based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

The proposed start date is ASAP - We need YOU

Responsibilities include:
  • 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 the clients GMP Capital Project procedure.
  • Deputise for the Process Engineering Manager providing technical guidance and training to the wider Pharmaceutical 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 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.
  • Responsible for troubleshooting and liaising with maintenance technicians, engineers and users to establish the root cause, develop and manage appropriate corrective action plans and report through the the clients non conformance system, for failures/performance issues.
  • Represent Engineering as Project Engineer and system expert on capital projects.

Requirements:
  • Masters Degree in Process or Chemical Engineering with post graduate experience in a plant and/or design engineer role
  • Chartered Engineer Status (i.e. typically 4 years Post Graduate in a Professional Institute Approved Structured Programme, Peer Reviewed Report, fully attested training and experience diary followed by Interview with Chartered Institute)
  • Extensive experience in an Engineering operational and design role in the Pharmaceutical Industry.
  • Experience of Successfully leading a variety of major specialist engineering initiatives
  • Effective leadership and project management skills
  • Experience of Regulatory Audits
  • Experience in Preparing Detailed GMP Engineering Technical Documentation
  • Project Management training

Knowledge/Experience
  • Extensive Practical, pharmaceutical industry experience of facilities, equipment and GMP Critical Utilities operation, design, commissioning and validation.
  • Experience of current available engineering/equipment technology and its subsequent sizing/selection to support Pharmaceutical Operations
  • Experience of working within a GMP Quality System, in particular, change control, Non Conformance management, CAPA, discrepancy/deviation, and documentation management.
  • Experience of the design, and control of capital project design documentation within a GMP quality systems environment.
  • Experience of project management of capital project delivery within a pharmaceutical manufacturing environment.
  • Experience of dealing with internal customers, negotiating and agreeing work programmes, reporting progress, dealing with issues to ensure delivery and customer satisfaction
  • Experience as an SME of FDA and MHRA Regulatory inspections
  • Specialist knowledge of Biopharmaceutical GMP Manufacturing processes, associated equipment technologies and design, acquired through post graduate diploma or practical experience
  • 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)
  • Working knowledge of pharmaceutical facility design and construction and comprehensive understanding of the underlying engineering principals
  • Evidence of post qualifying and continuing professional development
  • Member of relevant professional body
  • Accurate and clear record keeping
  • Wide GMP experience
  • Specialist knowledge of Utilities System Design Concepts, and solutions relating to GMP pharmaceutical production Facilities.

If you are interested please do not hesitate to email or call me!

+44 20 30969 392

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