Project Manager-Clean Utilities, Autoclaves, Parts washer

LSC, Life Science Consultants; Munster; On-site; EUR 70,000 - 90,000; Full time

Job summary

LSC, Life Science Consultants partners with a Kerry-based biopharmaceutical company to recruit a Project Manager for Clean Utilities, Autoclaves and Lyophilisation operations. You will lead cross-functional teams across project delivery, technology transfer, and commissioning/validation activities in a cGMP environment.

The role requires 5+ years in pharma/biotech, strong experience with lyophilisation, CIP/SIP/FIT, and process control systems.

Qualifications

• Bachelor's or Master's degree in a relevant field.
• Experience in freeze-drying/lyophilisation projects in pharma/biotech.
• Experience in a cGMP start-up environment with Lyophilisation expertise CIP/SIP/FIT.
• Experience with process control, instrumentation, qualification, and validation.

Responsibilities

• Manage projects, technology transfer, and commissioning/validation with cross-functional teams.
• Apply analytical and project execution skills with PAT, automation, SCADA/HMI, and cycle modelling.
• Support lyophilisation operations and control systems to meet production schedules.
• Ensure GMP compliance and data integrity of computerized systems.
• Lead incident, deviation, and CAPA investigations with root cause analysis and corrective actions.

Skills

Project management

GMP compliance

Process engineering

PAT

Automation

SCADA/HMI

Data integrity

Root cause analysis

Education

Bachelors in Chemical Engineering

Masters in Bioprocess Engineering

Tools

CIP/SIP

Lyophilisation equipment

Qualification equipment

Job description

LSC have a great contract opportunity for a Project Manager-Clean Utilities, Autoclaves, Parts washero 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.