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Mechanical Engineering SME

Mechanical Engineering SME

  • Location:


  • Sector:

    Engineering & Manufacturing

  • Job type:


  • Salary:


  • Contact:

    Next Generation

  • Contact email:

  • Job ref:


  • Published:

    7 months ago

  • Duration:

    12 Months

  • Expiry date:


The Critical Utilities Team is actively seeking a Site Mechanical Engineering SME to serve as the subject matter expert in Mechanical Engineering for ongoing projects in Pharmaceutical manufacturing systems and Critical Utilities (Clean & Black), Manufacturing. Join us in ensuring the efficient operation and reliability of our site's Mechanical systems.


  1. Compliance Assurance:
  • Ensure modifications and additions to systems comply with Regulatory requirements, including Quality (cGDP/GMP's), EHS, CE Compliance, Global Engineering, and local regulations in Mechanical discipline.
  1. User Requirements Development:
  • Develop user requirements for new equipment and modifications, collaborating with stakeholders from concept to installation.
  1. CMMS Data Management:
  • Develop, review, and update CMMS data, calibration data sheets, spare parts requirements, PMs, PdMs, job plans, etc., to optimize reliability-based maintenance programs.
  1. Root-Cause Failure Analysis:
  • Perform and facilitate root-cause failure analysis (Cause Mapping) on chronic/critical/high-impact failures.
  1. Preventative and Predictive Maintenance:
  • Minimize unscheduled equipment downtime through effective preventative and predictive maintenance programs and rapid response to equipment failure.
  1. Vendor and Contractor Oversight:
  • Review and accept reports from vendors and contractors, develop action plans, and raise CMs/PMs/Pdms to address issues.
  1. Compliance Support:
  • Support all compliance efforts, including risk assessments, RCA investigations, CAPAs, and the review/approval of engineering change controls.
  1. Project Management:
  • Raise Project Request Documents (PRDs) and manage projects for site improvements or the addition of new equipment.
  1. Continuous Improvement:
  • Advocate for continuous improvement in processes and systems.
  1. Audit Support:
  • Support site audits with the Engineering technical services SME team as required.
  1. Designee Responsibilities:
  • Serve as a designee for the Critical Utilities, Clean utilities, or HVAC SME in appropriate circumstances.

Required Competencies:

  • Team player with leadership capabilities in a collaborative environment.
  • Ability to provide solutions aligned with business objectives and cost implications.
  • Detailed knowledge and experience in operating and designing Mechanical systems.
  • In-depth knowledge of regulatory requirements in the pharmaceutical/biopharmaceutical industry.
  • Experience dealing with regulatory agencies.
  • Proficiency in managing complex projects in or around operating facilities.
  • Ability to work independently and remotely with minimal supervision.
  • Proactive problem-solving using Technical, Project Management, and Business expertise.

Required Qualifications and Desired Experience:

  • Level 7/8 qualification in Mechanical Engineering / Chemical / Process Engineering.
  • Minimum 8 years of experience in pharmaceutical manufacturing facilities in a Projects design, maintenance engineering, or utilities engineering

The Next Step for you:
Should this position be of interest to you please forward your CV to Nuira Esmau at Next Generation Recruitment via the Apply button.

Next Generation are specialists in recruiting for roles in Data Science, Digital, Engineering & Life Sciences, IT, Supply Chain & Operation, Engineering and Procurement.

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