About the Role
We are looking for an experienced Utility Engineer to support ongoing activities within a pharmaceutical / life sciences manufacturing environment.
The role will focus on the operation, maintenance, troubleshooting and improvement of critical utility systems, including Reverse Osmosis (RO), Water for Injection (WFI) and clean steam systems.
The ideal candidate will have strong hands-on experience with critical utilities and a good understanding of GMP, deviation management and change control within a regulated manufacturing environment.
Key Responsibilities
- Lead and support activities related to critical utility systems, including:Reverse Osmosis (RO)Water for Injection (WFI)Clean SteamOther critical pharmaceutical utility systems
- Lead and manage change controls associated with new utility equipment and project activities.
- Support the installation, commissioning, qualification and implementation of new utility equipment and systems.
- Oversee and support the operation and maintenance of critical utility equipment.
- Conduct in-depth troubleshooting and root-cause analysis for equipment failures and operational issues.
- Lead investigations into deviations raised in TrackWise, particularly those related to critical utility systems.
- Develop and implement appropriate corrective and preventive actions (CAPA) where required.
- Work closely with Engineering, Maintenance, Quality, Validation and Production teams to resolve utility-related issues.
- Ensure critical utility systems operate reliably and in accordance with applicable GMP and site procedures.
- Provide technical support for ongoing utility improvement and engineering projects.
- Maintain appropriate technical and project documentation related to utility systems.
Requirements
- Degree or Diploma in Chemical Engineering, Mechanical Engineering, Electrical Engineering or a related engineering discipline.
- 4-10 years of relevant engineering experience, preferably within the pharmaceutical, biotech, life sciences or other GMP-regulated manufacturing environment.
- Strong hands-on experience with critical utility systems, particularly:Reverse Osmosis (RO)WFI systemsClean SteamOther pharmaceutical-grade utility systems
- Experience managing change controls for utility equipment and engineering projects.
- Good knowledge of utility equipment operation, maintenance and troubleshooting.
- Experience investigating deviations within TrackWise or similar quality management systems.
- Strong problem-solving and root-cause analysis capabilities.
- Familiarity with GMP requirements and regulated manufacturing environments will be highly advantageous.
