Process Engineer

Recruitment by Aphex; Waterford; On-site; EUR 70,000 - 90,000; Full time

Job summary

Recruitment by Aphex is seeking a Shift Process Engineer to lead aseptic manufacturing operations on a 24/7 shift pattern in Waterford. This role focuses on delivering compliant, efficient processes and supporting capital projects.

You will apply design of experiments, statistical methods, and robust problem-solving to drive continuous improvement, ensure GMP compliance, and support new product introductions and tech transfer.

Qualifications

• Degree required in Chemical, Industrial, or related Engineering.
• Candidate with advanced pharmaceutics degree preferred.

Responsibilities

• Provide leadership and technical support to manufacturing operations.
• Ensure GMP and cGMP compliance across activities.
• Lead process development and continuous improvement initiatives.
• Support capital projects and tech transfer activities.
• Act as SME for product quality attributes and critical process parameters.
• Design and execute experimental studies and assessments.
• Maintain quality documentation and CAPA closure.
• Collaborate with cross-functional teams to optimise operations.

Skills

Aseptic processing

DOE & statistics

Pharma development lifecycle

Communication skills

Lab & pilot-plant capability

R&D creativity

Project management

Statistical problem-solving

Education

Chemical/Industrial Engineering degree

Advanced degree in Pharmaceutics/Pharmacy (advantage)

Job description

Shift Process Engineer (24/7 Shift Pattern)

Shift Pattern: Two days (07:00-19:00), two nights (19:00-07:00), followed by four days off

Purpose

Provide leadership and technical support to manufacturing operations, ensuring all standards are met and continuous improvement is driven across all development and manufacturing activities.

Responsibilities

• Operational leadership - Support manufacturing teams to maintain compliant, efficient operations
• Customer & supplier liaison - Engage with internal and external stakeholders to optimise operational performance.
• Process optimisation - Identify, evaluate, and implement improvements across manufacturing and development operations.
• Capital project support - Assist in planning and implementing capital projects.
• Inspection process lead - Act as process lead for inspection development activities.
• Technical problem‐solving - Lead root cause analysis and technical issue resolution with cross‐functional teams.
• Performance monitoring - Implement and track key performance indicators.
• Cycle‐time reduction - Drive initiatives to reduce process cycle times.
• Best‐practice implementation - Embed industry best practices across operations.
• Process development - Design, execute, and implement process development programmes and plant trials.
• Continuous improvement - Challenge existing standards and promote ongoing improvement.
• Quality documentation - Maintain all required quality documentation in a compliant state.
• New product introduction support - Act as SME for new product introduction and enhancement projects.
• Clinical supply support - Provide technical support for clinical supply provision projects.
• Aseptic manufacturing context - Support operations within aseptic manufacturing environments.
• Product & process SME - Serve as SME for product quality attributes and critical process parameters.
• Experimental programme design - Design and execute experimental studies.
• Process laboratory operation - Operate and support process laboratory activities.
• Scale‐up & tech transfer - Support scale‐up and technology transfer projects.
• Cross‐functional liaison - Liaise with teams involved in formulation, enhancement, and clinical supply.
• Quality system support - Support complaints, LCRs, deviations, and CAPAs, ensuring effective RCA and timely closure.
• SMART goal delivery - Achieve defined SMART goals.
• GMP compliance - Ensure adherence to cGMP at all times.

Qualifications

• Degree in Chemical, Industrial, or related Engineering discipline.
• Advanced degree in Pharmaceutics, Pharmacy, or related scientific field is an advantage.

Skills & Knowledge

• Aseptic manufacturing expertise - Technical knowledge of aseptic processing; lyophilisation experience is an advantage.
• Design of Experiments and associated statistical techniques.
• Pharmaceutical development lifecycle.
• Strong report writing and communication skills.
• Laboratory and pilot‐plant capability.
• Research, innovation, and creativity skills.
• Project management capability.
• Structured problem‐solving using statistical tools.