Senior Equipment Engineer - Dundalk

Senior Equipment Engineer

We are excited to announce a fantastic opportunity for a Senior Equipment Engineer at our state-of-the-art site in Dundalk. Our facility is dedicated to formulating and filling vaccine products that improve and transform lives globally. This role offers a unique opportunity to provide technical leadership and support for Vial Filling Equipment and associated machinery. By joining our team, you will play a crucial role in improving and transforming lives globally.

Your Core Responsibilities

• Provide technical leadership within a new Vaccine DP facility, ensuring equipment safety, effectiveness, and compliance.
• Adhere to company and site engineering policies and procedures, and review/authorship of testing protocols, reports, and manufacturing SOPs.
• Lead Commissioning & Qualification activities for new equipment and manage Equipment Vendors, including SAT, maintenance visits, and continuous improvement projects.
• Participate in cross-functional teams to troubleshoot technical issues, drive continuous improvement, and process optimization using DMAIC and FMEA tools.
• Manage changes to equipment/process as per site change control procedures and support the establishment of a Preventative Maintenance Program.
• You will have the opportunity to lead/participate in equipment-related manufacturing investigations to ensure root cause analysis, impact analysis, and CAPAs implementation.
• Provide technical expertise during regulatory inspections and support the transition from project to sustaining manufacturing, improving equipment reliability.
• Collaborate with the IPT Leader and multiple partners to ensure effective strategies, direction, and excellence in IPT/maintenance programs.

Who You Are

You are ready if you have:

• Technical expertise in machine and equipment maintenance programs within a regulated cGMP environment.
• Proven ability to lead Commissioning & Qualification activities and manage Equipment Vendors and continuous improvement projects.
• Strong understanding of cGMP activities including RA and CQV protocols/reports.
• Ability to troubleshoot and resolve technical issues using DMAIC and FMEA tools.
• Experience in managing changes to equipment/process as per site change control procedures and leading/participating in equipment-related manufacturing investigations.
• Experience in regulatory inspections (e.g., FDA, HPRA inspections).

Nice to have, but not essential:

• Experience in the pharmaceutical or biopharmaceutical industry.
• Knowledge of Preventative Maintenance Programs for equipment in Drug Product suites.
• Lean or Six Sigma experience.