Process Engineer

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.