Lyophilisation Lead Engineer – Kerry

Lyophilisation Lead Engineer – Kerry

An opportunity is now available for a Lyophilization Lead Engineer a site based role in the Kerry area. The successful candidate will be qualified with Bachelor’s or Master’s Degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field.

Responsibilities as SME:

• Manage and contribute throughout project, technology transfer, and commissioning/validation activities, providing process engineering expertise and leading or supporting cross-functional teams.
• Apply strong analytical, prioritization, and project execution skills, with experience in PAT, automation, SCADA/HMI, and cycle modelling
• Provide technical support to lyophilisation operations, engineering, and control systems to ensure efficient, compliant operations and achievement of project and production schedules.
• Ensure GMP compliance and data integrity of computerised systems, maintaining high system performance in line with site standards and regulatory expectations (FDA, EMA, ICH).
• Lead and support incident, deviation, and CAPA activities through effective investigation, root cause analysis, and timely implementation of corrective actions.
• Drive proactive problem solving, process optimisation, and continuous improvement initiatives using Lean Six Sigma, delivering measurable performance, cost, energy, and waste reduction benefits.
• Responsibilities also include training and developing staff, preparing and maintaining production SOPs and related documentation, promoting strong teamwork and a culture of safety awareness.
• The role ensures compliance with cGMP, ISO 14001, Health & Safety, and Environmental legislation,
• Supports cross-functional compliance efforts and operates equipment as required to support lyophilisation operations

Preferred Knowledge & Experience:

• Experience in freeze-drying/lyophilisation projects or operations in pharma/biotech. (e.g., vial processing in Lyomax 30).
• Experience in a cGMP start up environment is preferred along with advanced technical experience including: expert knowledge relating to Aseptic vial Lyophilisation process, including CIP, SIP & FIT.
• Experienced with process control systems, process instrumentation, equipment qualification, and process validation.
• Possesses excellent organisational, interpersonal, verbal communication and written communication skills.
• Ability to work effectively using own initiative or as a member of a team as required.

Arcadis is a leading Project Management and Engineering Company delivering Full-Service Engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time.

Arcadis is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.