Be the on‑site piping expert driving safe, compliant execution on a fast‑track NAPI build.
Proclinical is seeking a Process Engineer to support and optimize pharmaceutical manufacturing processes with a strong focus on pelletising and coating technologies. The successful candidate will work in a GMP-regulated environment, supporting process design, scaleup, troubleshooting, validation, and continuous improvement for oral solid dosage forms.
This role requires strong hands-on technical expertise, excellent GMP documentation skills, and close collaboration with Manufacturing, Quality, Validation, and Technical Operations teams.
Responsibilities:
Process Engineering & Manufacturing Support
- Lead and support pelletising and coating processes, including but not limited to:
- Extrusion-spheronisation
- Powder layering
- Solution and suspension layering
- Functional and non-functional coating of pellets and multiparticulates
- Provide day-to-day engineering support to manufacturing operations, ensuring robust, compliant, and efficient processes.
- Troubleshoot process deviations related to:
- Pellet formation, drying, sizing
- Coating defects (e.g. agglomeration, overwetting, spray issues, film defects)
- Act as process SME for pelletising and coating equipment during routine manufacturing and investigations.
Process Development & Optimization
- Design, optimize, and scale pelletising and coating processes to ensure consistent product quality.
- Define and control critical process parameters (CPPs) and critical quality attributes (CQAs) for pellet formation and coatings.
- Support process robustness activities, including design space evaluation where applicable.
- Identify and implement process improvements to enhance yield, throughput, and quality.
- Support implementation of new products, equipment, or process changes.
GMP, Validation & Documentation
- Author and review GMP documentation, including:
- Batch manufacturing records
- SOPs and work instructions
- Risk assessments (e.g. FMEA)
- Technical and validation reports
- Support process validation activities, including IQ, OQ, PQ/PPQ for pelletising and coating processes.
- Support deviation investigations, root cause analyses, CAPAs, and change controls.
- Ensure compliance with GMP, EU/FDA regulations, and internal quality standards at all times.
- Act as technical support during regulatory inspections and audits, particularly for pellet and coating processes.
Cross Functional Collaboration
- Collaborate closely with:
- Manufacturing & MSAT
- Quality Assurance & Validation
- Maintenance, Automation & Engineering
- R&D, Technology Transfer, and external vendors
- Support technology transfer and scale?up activities from development to commercial manufacturing.
- Provide technical input for equipment selection, upgrades, or modifications related to pelletising and coating.
Key Skills and Requirements:
- Degree or trade qualification in Construction Management, Engineering, or a related discipline (or equivalent practical experience).
- Strong background in construction management within pharmaceutical or regulated manufacturing environments.
- Proven experience delivering brownfield projects in live GMP facilities.
- Familiarity with API or NAPI projects is preferred.
- Demonstrated ability to manage multidisciplinary contractors on fast-paced capital projects.
- Solid understanding of GMP construction requirements and EHS leadership.
- Strong onsite leadership, organizational skills, and communication abilities.
- Ability to make sound decisions in dynamic environments.
If you are having difficulty in applying or if you have any questions, please contact Ed Little at e.little@proclinical.com.
Apply Now:
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