Job Descriptions

We are urgently seeking a Clean Utilities Engineer for a leading Pharmaceutical Company based in Sligo.

The Clean Utilities Engineer will take ownership for clean utilities (Purified Water, Water for Injection, Clean Steam, High Quality Compressed Air and Nitrogen Distribution) and to work as a team member in line with all safety, regulatory and organizational requirements. They will provide technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant. This position requires developing and implementing changes that will improve equipment performance and consequently product quality.

Responsibilities:
- 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 programmes.
- Delivery of safety, performance and quality goals
- 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.
- To liaise with Internal/External Engineering Personnel and contract maintenance providers in maintaining, trouble shooting and installing/commissioning equipment.
- Support the Production Team in ensuring that utility equipment is maintained to meet requirements
- Present on clean utility area in regulatory inspections ensuring successful outcomes
- Cross functional collaboration with QC Micro, Operations, QA and Engineering

Requirements:

- A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Masters Preferable)
- At least five (5) 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 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.

Skills

Experience

• 5 years