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Clean Utilities Engineer
- Full Time
- Mid-Senior Level
Team Horizon currently has an exciting opening for a permanent Clean Utilities Engineer to work on our client’s manufacturing facility in Co. Sligo. In your new role you will own the utilities systems, including; purified water, water for injection, clean steam, high quality compressed air and nitrogen distribution across an advanced biologics site.
Why you should apply:
- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
- The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
- Excellent career progression opportunities.
What you will be doing:
- Acting as the subject matter expert from the design phase to equipment handover, in mechanical, electrical and pneumatic utility systems.
- Reviewing and approving process flow diagrams, specifications, layouts and P&ID’s.
- Leading, supervising and delivering the implementation and maintenance of the relevant safety programs.
- Supporting clean utility equipment installation, integration and coordinate vendor supervision as required.
- Developing and modify procedures as needed to support the clean utility area.
- Reviewing 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.
- Taking part in and lead clean utility project implementations.
- Leading of clean utility and validation activities during the project life cycle.
- Investigating process exceptions or equipment malfunction incidents affecting the process.
- Liaising with internal/external engineering personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment.
- Helping the production team, ensuring that utility equipment is maintained to ensure production schedules run efficiently.
- Presenting on clean utility area in regulatory inspections ensuring successful outcomes
- Adhere to the Health and Safety policy and procedures.
What you need to apply:
- Bachelor’s degree in an engineering, science or technical discipline
- 5+ years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering in Pharma, Biotech or Medical Device Industry.
- Experience in manufacturing biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, Lyophilisation, sterilisation operations preferable. Experience in clean utilities is essential.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Familiarity with policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.
- Influential management style, with the ability to articulate expectations and communicate with key stakeholders, team members and contractors.
- Focused on meeting targets.
- Total commitment to quality.