Job Reference: JO-2005-65178_1588785241
Clean Utilities Engineer
We are now recruiting a Clean Utilities Engineer to join my clients engineering team. As the Clean Utilities Engineer you will take ownership for utilities systems including purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution across an advanced biologics site.
- Clean Utility Engineering Subject Matter Expert from design phase to equipment handover.
- Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID's.
- SME in mechanical, electrical and pneumatic utility systems.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programs.
- Support clean utility equipment installation, integration and co-ordinate vendor supervision as required.
- Develop and modify procedures as needed to support the clean utility area.
- 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.
- Participate and lead clean utility project implementations.
- Leadership of clean utility and validation activities during project life cycle.
- Investigate process exceptions or equipment malfunction incidents affecting the process.
- Liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, trouble shooting and installing/commissioning equipment.
- Support the production team ensuring that utility equipment is maintained to ensure production schedules run efficiently.
- Present on clean utility area in regulatory inspections ensuring successful outcomes.
- Cross functional collaboration with QC Micro, Operations, QA and Engineering.
- Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
Technical Skills and Experience
- A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable).
- At least six (6) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
- At least three (3) years of continuous experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.
- Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, fill finish, lyophilisation, sterilisation operations preferable. Experience in clean utilities is essential.
- Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.
- Ability to influence, clearly articulate expectations and communicate with key stake holders, team members and contractors.
- Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
- Total commitment to quality and a high standard of work always.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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