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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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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