LSC have a great contract opportunity for a Project Manager/SME to join a Kerry based Biopharmaceutical company.
The role provides technical support to the Projects Department by conducting effective investigations, root cause analysis, and implementing corrective actions to ensure efficient lyophilization operations and adherence to manufacturing schedules
Responsibilities:
- Provide technical support to lyophilisation, engineering, and control systems to ensure efficient, compliant operations and achievement of project schedules.
- Ensure GMP compliance and data integrity of computerised systems within remit, maintaining high system performance in line with site standards and regulatory expectations (FDA, EMA, ICH).
- Manage and contribute to projects, technology transfer, and commissioning activities, providing process engineering expertise and leading or supporting cross-functional teams.
- Apply strong analytical, prioritisation, and project execution skills, automation, SCADA/HMI, and cycle modelling, while remaining adaptable to changing project needs.
Preferred Knowledge & Experience:
- Experience in freeze-drying/lyophilisation in pharma/biotech.
- (e.g., Lyomax 30).
- Experience in a cGMP start up environment is preferred along with advanced technical 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.
- Ability to work effectively using own initiative or as a member of a team as required.
Education:
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field, or significant relevant experience.
Apply via this advert or contact Siobhan Cummins at LSC on 021 4777329 if you have any more questions about this role!
