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Mechanical SME

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
12-06-2023
30555

This vacancy has now expired

Mechanical SME – Pharmaceuticals – Part Time Contract – Remote (USA)

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a Mechanical SME to help support operations at their facility. It is a remote based, part time contract (8-12 hours per week) with some site visits required.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

Mechanical SME Responsibilities:

  • Work with Design Contractor to develop the design, translating company technical requirements into Engineering deliverables.
  • Review Design Contractor enquiry specifications for these systems and involvement in the bid review/ selection for these systems
  • Review all documentation (drawings & calculations) within this area to ensure correct interpretation of company requirements.
  • Review and approve FAT & SAT protocols, (as required).
  • Attend relevant FATs, mechanical completion inspections & SATs
  • Prepare the User Requirement Specification (URS’s) for each GMP system, assure they are complete (GMP, GEP and SHE requirements), technically correct and appropriate for C&Q execution.
  • Champion the timely engagement, review and approval of URSs with company Customer team.
About you:
  • Strong collaborator with ability to create and maintain effective working relationships and willing to challenge behaviours and actions.
  • Demonstrated practitioner of practical problem-solving.
  • Detail focused completer/finisher with a results-orientated mindset.
  • Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change.
  • Collaborate and work in partnership with multiple customer teams to deliver programme/project objectives,
Are you a Mechanical Subject Matter Expert looking for a part time contract? This could be the role for you! Get in touch with us today to apply.

The candidate must have the rights to work in the location stated in the job advert.

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