Summary:
Our client, a leading biopharmaceutical company based in Dublin, is seeking an Equipment Engineer to join its engineering team. The successful candidate will provide technical support to production and maintenance, with engineering ownership of drug substance process equipment. The role will provide technical leadership for equipment and process issues while supporting operational readiness, equipment reliability, new installations, capital projects and continued compliance with GMP, safety and regulatory requirements.
Responsibilities:
- Drive continuous improvement activities across engineering teams.
- Lead complex troubleshooting and structured problem-solving activities relating to process equipment.
- Provide technical support during the installation and commissioning of new equipment.
- Oversee operational readiness activities, including the development of maintenance job plans and procedures and the identification of spare parts.
- Work closely with other site functions to support a smooth transition between project and operational phases.
- Provide equipment design input for new product introductions and related capital projects.
- Take ownership of process safety and equipment-related investigations.
- Develop and deliver technical training relating to process equipment.
- Monitor and manage engineering key performance indicators to support process optimisation.
- Promote and maintain a strong safety culture and performance within the Maintenance and Engineering teams.
- Optimise equipment and process design to improve the turnaround of production equipment.
- Plan and manage day-to-day technical support for process equipment to meet manufacturing and plant shutdown schedules while maintaining GMP compliance and cost efficiency.
- Implement equipment and maintenance reliability improvements, including area and equipment improvement plans to prevent repeat failures and address maintenance issues.
- Review completed maintenance activities and identify improvements to maintenance job plans.
- Ensure compliance with site governance standards and regulatory requirements.
- Support regulatory audits as the equipment Subject Matter Expert.
- Act as the key Engineering contact for Production regarding equipment and maintenance performance.
Qualifications & Experience:
- Degree in Pharmaceutical, Chemical or Mechanical Engineering, or a related engineering discipline.
- Minimum of five years’ experience in a technical engineering role within the pharmaceutical or biotechnology industry.
- Experience with upstream or downstream drug substance and packaging processes would be advantageous.
- Demonstrated proficiency in vendor management and issue resolution.
- Experience leading and facilitating structured problem-solving activities to resolve equipment and process issues.
- In-depth knowledge of regulatory requirements and current health and safety legislation.