Process Engineer

Morgan McKinley; Galway; On-site; EUR 65,000 - 90,000; Full time

Job summary

Morgan McKinley in Ireland is seeking a Process Engineer (Technical Services) to support aseptic manufacturing, tech transfers, and continuous improvement initiatives. You will optimize scalable production while ensuring strict regulatory compliance (cGMP, FDA/EMA) and provide technical expertise for NPI and process validations.

Key responsibilities include process development and scale-up, validation and regulatory support, on-the-floor troubleshooting, and driving Lean/Six Sigma improvements

Qualifications

• Bachelor's or Master's in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related field.
• 3–7 years in pharmaceutical process engineering with at least 2 years in sterile injectables or biologics.
• Strong knowledge of aseptic processing, sterilization, and lyophilization.
• Hands-on with isolators, filling machines, autoclaves, depyrogenation tunnels, and single-use systems.
• Deep understanding of PPQ, DOE, SPC and regulatory guidelines (cGMP, FDA, EMA, ICH).
• Proficient in cGMP documentation, technical writing, and data analysis software (Minitab).

Responsibilities

• Design, optimize, and scale up aseptic manufacturing processes and lead tech transfers and NPI.
• Author and execute PV/PPQ protocols and CPV; generate change controls and regulatory filings (CMC).
• Provide on-the-floor troubleshooting and lead root-cause investigations for deviations.
• Utilize Lean/Six Sigma to evaluate new technologies, optimize yield, and reduce waste while maintaining compliance.

Skills

Aseptic processing

Terminal sterilization

Lyophilization

DOE

SPC

Process Validation

Regulatory guidelines

cGMP documentation

Data analysis (Minitab)

Education

Bachelor's or Master's in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or related field

Tools

Minitab

SCADA/MES

Job description

A leading pharmaceutical organization is seeking a Process Engineer (Technical Services) to support aseptic manufacturing processes, technology transfers, and continuous improvement initiatives.

This role focuses on optimizing scalable production, ensuring strict regulatory compliance (cGMP, FDA, EMA), and providing technical expertise for New Product Introductions (NPI) and process validations.

Key Responsibilities

• Process Development & Scale-Up: Design, optimize, and scale up aseptic manufacturing processes. Conduct FMEA risk assessments, establish CPPs/CQAs, and lead tech transfers and New Product Introductions.
• Validation & Regulatory Compliance: Author and execute Process Validation (PV/PPQ) protocols and Continued Process Verification (CPV). Generate change controls and provide technical data for regulatory filings (CMC).
• Manufacturing Support: Provide on-the-floor troubleshooting, lead root-cause investigations for deviations, and analyze data trends to reduce variability in critical quality attributes.
• Continuous Improvement: Utilize Lean/Six Sigma tools to evaluate new technologies, optimize yield, and reduce waste while maintaining compliance.

Essential Qualifications

• Education: Bachelor's or Master's in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, or a related field.
• Experience: 3-7 years in pharmaceutical process engineering, including at least 2 years in sterile injectables or biologics.
• Technical Expertise:
  • Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.
  • Hands-on familiarity with isolators, filling machines, autoclaves, depyrogenation tunnels, and single-use systems.
  • Deep understanding of process validation (PPQ), DOE, SPC, and regulatory guidelines (cGMP, Annex 1, FDA, EMA, ICH).
  • Proficient in cGMP documentation, technical writing, and data analysis software (e.g., Minitab).

Desirable: Lean/Six Sigma certification, experience with automation (SCADA/MES), or PAT knowledge.