LSC have a great contract opportunity for a Project Manager/SME to join a Kerry based Biopharmaceutical company.
If you have 5+ years of experience working in the pharmaceutical or biotechnology industry, then please reach out. This might be the ideal role for you!
RESPONSIBILITIES:
- 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.
EDUCATION/EXPERIENCE:
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Bioprocess Engineering, Biotechnology, or related field
- 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.
Apply via this advert or contact Cian Marnane at LSC on 021 4777329 if you have any more questions about this role!
