Clean Utility Lead
Amazing opportunity for an ambitious Clean Utility Lead to join a world class biotechnology company in Louth. The ideal candidate will be responsible for the sites utilities systems including purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution. This person will also implement planning and distribution for PM work orders and initiate operation plans.
- Initiate and revise SOP for CU system, monitor execution of SOP in EHS and GMP area, and implement training to ensure operation staff activities are followed. Deal with any issues during operation accordingly.
- Review and approve process related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols in a timely basis to meet the project schedule requirements
- Prepare and support internal /external audits.
- Involved in the clean utility URS, installation and construction supervision, co-lead C&Q, support PQ and calibration activities.
- Liaise with Internal/ External Engineering Personnel and contract maintenance providers in maintaining, trouble shooting and installing/ commissioning equipment.
- Present on clean utility area in regulatory inspections ensuring successful outcomes
- Cross functional collaboration with QC Micro, Operations, QA and Engineering
- Initiate proper material and spare part plan for above CU system.
- Related change, deviation and CAPA follow up.
- Conduct system health monitoring, opportunity assessment and continuous improvements.
- Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
- Bachelor's degree in Engineering
- 5+ years of relevant experience in clean utilities is essential.
- 2+ years of biotechnology, pharmaceutical or health care manufacturing work experience. Prior experience of working in biologics/ vaccine field would be advantageous.
- Excellent English oral and written communication skills, leadership ability and ethical judgement
- Ability to influence, clearly articulate expectations and communicate with key stake holders, team members and contractors.
- Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.
- Ability to work effectively with minimal supervision
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please call Lisa Cooney +353 (0) 21 428 9624 or send your CV to firstname.lastname@example.org