Pharma Equipment Engineer - Process Reliability Compliance

Tandem Project Management Ltd.; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. is seeking an Equipment Engineer for its Dublin-based client, a leading biopharmaceutical company.

You will provide technical support to production and maintenance and own equipment for drug substance processes, ensuring GMP compliance and regulatory readiness. Responsibilities include leading troubleshooting, equipment installations, maintenance planning, and safety investigations, while driving improvements and collaborating with site functions on

Qualifications

• 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.

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.

Skills

Vendor management

Problem solving

Regulatory compliance

Equipment maintenance

Education

Degree in Pharmaceutical, Chemical or Mechanical Engineering

Job description

Tandem Project Management Ltd. is seeking an Equipment Engineer for its Dublin-based client, a leading biopharmaceutical company.

You will provide technical support to production and maintenance and own equipment for drug substance processes, ensuring GMP compliance and regulatory readiness. Responsibilities include leading troubleshooting, equipment installations, maintenance planning, and safety investigations, while driving improvements and collaborating with site functions on