Project Engineer / Manager - Clean Utilities
We are seeking an experienced Project Engineer / Manager to join our team at the largest Centre of Excellence for veterinary vaccine development and production in the world.
About the Role
* Take charge of multiple projects at Carlow, overseeing their entire lifecycle from scope development, design, build/installation, and qualification to handover to operations.
* Develop project scope, cost estimates, and delivery schedules in collaboration with the Site Engineering team and system SMEs.
* Collaborate closely with cross-functional teams to identify and establish improvement projects within Carlow as the site scales up towards full commercial operation.
* Drive and support continuous improvement initiatives by actively participating in projects, conducting system failure investigations, contributing to investigation reports, executing and developing change control processes, and taking part in events when appropriate.
Key Responsibilities
* Serve as a liaison between global engineering services, utilities, and specialist vendors to ensure timely and successful delivery of projects.
* Ensure compliance with Global Policies, Procedures, and Guidelines, as well as regulatory requirements, while adhering to current Good Manufacturing Practices (cGMP).
* Accountable for completing relevant documentation, conducting risk assessments, closing out corrective actions, participating in audits and inspections, and proactively identifying compliance issues.
Requirements
* Extensive experience in a similar role, preferably with a background in the GMP pharmaceutical industry.
* Demonstrated experience in the Utilities area within a manufacturing environment, with a successful track record of delivering engineering projects.
* Equipment experience: e.g., Plant steam boilers, CTUs, freezers, WFI, Clean steam, compressed air, HVAC, fume hoods, BSCs, F-gas regulations.
* Knowledge of regulatory and code requirements in accordance with Irish, European, and International Codes, Standards, and Practices.
Desirable Qualifications
* Strong skills in writing reports, developing standards, and creating policies.
* Proficiency in Microsoft Office and relevant computer applications related to the job.
* Desired experience in Lean Six Sigma Methodology to drive process improvement initiatives.
* Possess a strong commitment to safety and prioritise a safety culture.