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Simtra BioPharma SolutionsPosted 4 weeks ago

Manager, Process Engineering

On-siteBloomington, Indiana, United States

Full TimeStartupPharmaceutical Manufacturing

Job Summary

Lead aseptic processing, filling, and packaging operations while managing a team of engineering professionals and technicians. Provide daily guidance, direction, and leadership across 24/7 shifts, overseeing capital equipment budgets, value improvement projects, and process optimization. Ensure compliance with master change control management and validation protocols, utilizing Lean principles to maintain quality, safety, and budget constraints. Manage project timelines for equipment design specifications, procurement, design of experiments, factory acceptance testing, installation, and validation activities. Review and approve engineering work orders, master change controls, exception reports, technical summaries, expense approvals, and CAPAs. Conduct annual performance reviews and develop staff growth plans. Requires a Bachelor's in Engineering, 10+ years in aseptic manufacturing, and ability to gown qualify for Grade A/B areas. Duties include overtime, nights, weekends, and long hours sitting or standing.

Required Qualifications

  • Bachelors degree in Engineering discipline
  • Minimum 10 years of experience in aseptic manufacturing
  • Minimum 5 years supervisory experience
  • Must be able to gown qualify for Grade A/B
  • Must be able to lift up to 50lbs
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting or standing for long hours
  • Duties may require overtime work, including nights and weekends

Desired Qualifications

  • Advanced degree

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