Lead Sterile Process Engineer

About the Company

A global life sciences organisation is seeking a Lyophilisation Lead Engineer to support its sterile manufacturing operations in Ireland. The site is part of a wider international network focused on developing and delivering high-quality therapies in areas of significant unmet medical need, including oncology, immunology, urology, ophthalmology, and women’s health.

This is a hands-on technical leadership role within a highly regulated GMP environment, offering the opportunity to directly influence process performance, compliance, and continuous improvement in a critical manufacturing function.

Role Purpo

seThe Lyophilisation Lead Engineer will provide technical expertise and leadership to support lyophilisation operations, ensuring robust, compliant, and efficient manufacturing performance. The role combines process support, deviation management, automation oversight, and continuous improvement leadershi

p.You will act as a key technical SME for freeze-drying operations and associated control systems, supporting both day-to-day manufacturing and long-term process optimisation initiative

s.Key Responsibiliti

• esProvide technical support for lyophilisation operations to ensure safe, compliant, and reliable productio
• n.Lead and support deviations, investigations, root cause analysis, and CAPA implementatio
• n.Ensure compliance with cGMP, data integrity requirements, and relevant environmental and safety standard
• s.Support process validation, equipment qualification, and technology transfer activitie
• s.Drive continuous improvement initiatives using Lean Six Sigma and operational excellence tool
• s.Work closely with QA, Manufacturing, Validation, Automation, and Engineering team
• s.Provide input into SCADA, automation systems, and process control troubleshootin
• g.Maintain and update SOPs, technical documentation, and training material
• s.Support and develop operational teams through coaching and technical guidanc

e.Required Experience & Qualificatio

• nsDegree in Chemical Engineering, Biotechnology, Pharmaceutical Sciences, Bioprocess Engineering, or related discipline (or equivalent experience
• ).Strong experience in pharmaceutical or biopharmaceutical manufacturing environment
• s.Hands-on exposure to sterile manufacturing and GMP operation
• s.Experience in deviation management, investigations, and CAPA processe
• s.Familiarity with automated control systems (e.g. SCADA, PLCs, or equivalent

).Desirable Experien

• ceDirect experience in lyophilisation (freeze-drying) operations or process developmen
• t.Exposure to aseptic vial filling and sterile injectable manufacturin
• g.Knowledge of CIP/SIP systems and process validation lifecycl
• e.Lean Six Sigma certification or demonstrable continuous improvement experienc
• e.Experience with PAT tools or advanced process monitoring system
• s.Background in tech transfer or commissioning/qualification activitie

s.