Staff Medical Device Autoinjector Engineer

Thermo Fisher Scientific UK

Greenville, United States
On-site
Autoinjector subject matter expert
Develop and maintain sops and ojt documents
Process characterization and cpp specification
Thermo Fisher Scientific UK is seeking a Staff Medical Device Autoinjector Engineer in Greenville, US, responsible for developing and maintaining SOPs, enhancing manufacturing processes, and ensuring compliance with regulatory standards. The ideal candidate should have extensive experience in pharmaceutical engineering and a strong focus on autoinjector devices, along with a collaborative mindset

Job Summary

  • The Staff Medical Device Engineer will be responsible for developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates.
  • Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations.
  • We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits!

Matching Summary

Match Score: 85

Thermo Fisher Scientific UK is seeking a Staff Medical Device Autoinjector Engineer in Greenville, US, responsible for developing and maintaining SOPs, enhancing manufacturing processes, and ensuring compliance with regulatory standards. The ideal candidate should have extensive experience in pharmaceutical engineering and a strong focus on autoinjector devices, along with a collaborative mindset.

Skills & Requirements

Must-have

  • Autoinjector subject matter expert
  • Develop and maintain SOPs and OJT documents
  • Process characterization and CPP specification
  • Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs)
  • Device Master Records (DMRs) and Design History File (DHF) updates

Nice-to-have

  • Process improvement methodologies (Lean, Six Sigma)
  • Cross-functional team collaboration
  • Fast-paced, dynamic environment

Key Requirements

  • Master's degree in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar
  • 8+ years of operations experience in pharmaceutical manufacturing
  • Experience working with Device vendors and OEMs
  • Strong experience working with Autoinjectors
  • Knowledge of regulatory requirements for devices and combination products (US and EU)
  • Knowledge of Device Quality Management Systems (ISO13485 and 21CFR820)
  • Experience managing Device Development Projects

Work Rights

Not specified

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