Clean Utilities Engineer
Job ID: JOB-11683
Clean Utilities Engineer New opportunity for Clean Utilities Engineer to join a well-established Sligo based multinational. As their Clean Utilities Engineer, you will take ownership of utilities systems including purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution across an advanced biologics site.
- Act as Clean Utility Engineering Subject Matter Expert from the 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 coordinate 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 on a timely basis to meet the project schedule requirements.
- Participate in and lead clean utility project implementations.
- The leadership of clean utility and validation activities during the 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, troubleshooting 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
- Requirements & Experience
- A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Master’s preferable)
- At least six (5) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering in Pharma, Biotech or Medical Device Industry.
- Previous experience in manufacturing 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 stakeholders, team members and contractors.
- Goal orientated towards meeting targets and metric standards as set by site/department and division leaders.
- Total commitment to quality and a high standard of work always.
For further information on this Clean Utilities role please contact Caroline Kingston on 086 8395531/ firstname.lastname@example.org Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
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