Senior Process Development Engineer, Pharma Manufacturing

Myn

Galway

On-site

EUR 90,000 - 120,000

Full time

6 days ago
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Job summary

Myn in Galway seeks an experienced process development engineer to lead cross‑functional activities from development to robust commercial production. The role is hands‑on, technically demanding and requires rapid impact with minimal ramp‑up time.

The candidate should have extensive pharma process development experience, strong DoE and statistical skills, and a proven track record in technology transfer and regulatory documentation. EU GMP/HPRA compliance is essential.

Qualifications

  • Degree in Chemical Engineering, Biochemical Engineering, Process Engineering or related field.
  • Extensive process development/engineering experience in pharma/biopharma/biotech.
  • Strong knowledge of EU GMP and HPRA for process development and tech transfer.
  • Proven experience with process characterization, scale‑up and tech transfer.
  • Proficiency in DoE/statistical tools and technical report writing.
  • Available to start on short notice due to contract nature.

Responsibilities

  • Lead process development, characterization, and optimization for assigned product/process area.
  • Design, execute, and analyze DoE studies and other development experiments.
  • Support tech transfer to Galway facility, ensuring robust, scalable processes.
  • Author/review process development documentation, risk assessments, and validation docs.
  • Identify/troubleshoot deviations, perform root cause analysis, drive CAPAs.
  • Collaborate with Manufacturing, Quality, Validation, Regulatory, and Automation teams.
  • Support regulatory submissions/inspections with technical data.
  • Drive continuous improvement to enhance robustness, yield, and efficiency.
  • Provide mentorship to junior engineers.
  • Ensure compliance with EU GMP, HPRA, and site EHS.

Skills

DoE methodologies
Statistical tools
Cross-functional collaboration
Technical problem-solving

Education

B.Sc./M.Sc. in Chemical/Biochemical/Process Engineering

Tools

JMP
Minitab

Job description

Myn in Galway seeks an experienced process development engineer to lead cross‑functional activities from development to robust commercial production. The role is hands‑on, technically demanding and requires rapid impact with minimal ramp‑up time.

The candidate should have extensive pharma process development experience, strong DoE and statistical skills, and a proven track record in technology transfer and regulatory documentation. EU GMP/HPRA compliance is essential.

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