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Senior Process Engineer (Indianapolis)

Senior Process Engineer (Indianapolis)

Medella LifeIndianapolis, IN, US
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About the Role

We are seeking a highly motivated and experienced Senior Process Engineer to join our team in Ireland. The successful candidate will play a key role in driving process improvements, supporting new product introductions, and ensuring the highest standards of safety, quality, and efficiency in our operations.

This role offers the opportunity to lead critical projects, mentor junior engineers, and collaborate cross-functionally with production, quality, and R&D teams to deliver sustainable process excellence.

Key Responsibilities

  • Lead the design, development, optimisation, and scale-up of manufacturing processes.
  • Identify, analyse, and implement process improvements to enhance safety, quality, yield, and cost-efficiency.
  • Support technology transfers, new product introductions (NPIs), and equipment commissioning / qualification.
  • Provide technical leadership and guidance to cross-functional project teams.
  • Develop and maintain process documentation (URS, P&IDs, SOPs, validation protocols).
  • Ensure compliance with Irish and EU regulations, GMP, ISO, and company quality standards.
  • Use Lean Six Sigma and data-driven methodologies to solve complex technical problems.
  • Train, mentor, and provide technical direction to junior engineers and technicians.
  • Support audits, inspections, and regulatory submissions as a subject matter expert (SME).
  • Drive sustainability and continuous improvement initiatives across production operations.

Qualifications & Experience

  • Bachelors or Masters degree in Chemical, Mechanical, Bioprocess, or related Engineering discipline.
  • 6+ years experience in process engineering, ideally within pharma, biotech, medtech, or advanced manufacturing.
  • Proven track record in process optimisation, validation, and technology transfer.
  • Strong knowledge of GMP, regulatory requirements, and safety standards (ATEX, PUWER, etc. as applicable).
  • Proficiency in process modelling, data analysis, and statistical tools (e.g., Minitab, JMP, or equivalent).
  • Lean Six Sigma Green Belt (Black Belt an advantage).
  • Excellent problem-solving, communication, and project management skills.
  • Ability to lead cross-functional teams and deliver results under tight deadlines.
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