Job Description

Who We Are:

NIRAS Ireland specializes in design and delivery of process-driven projects. We provide Project Management, Engineering Design, Project and Managed Service resources to the advanced Process Manufacturing, Life Science, Food & Beverage sectors across Ireland and internationally.

One of Europe's largest development consulting firms. NIRAS employs over 3000 permanent staff and has a pool of 25,000+ experts engaged across our network. With 51 offices in 32 countries, NIRAS has a local presence around the globe which is key to our success as we are committed to building long-term partnerships and capabilities where we work. A value-driven, multi-disciplinary engineering consultancy, NIRAS is fundamentally committed to sustainable progress and service delivery.

We are currently seeking a Project Engineer to join our client’s manufacturing site based in co Mayo.

The Role:

The successful Project Engineer will oversee and manage various aspects of pharmaceutical manufacturing projects, responsible for planning, coordinating, and executing engineering projects within the production facility. This role requires a strong background in pharmaceutical manufacturing processes, regulatory compliance, and project management.

Responsibilities:

· Collaborate with Quality Assurance and Regulatory Affairs teams to facilitate compliance and validation processes.

· Identify project stakeholders, establish clear communication channels, and define roles and responsibilities.

· Coordinate project activities and facilitated communication between cross-functional teams ensuring alignment with project goals.

· Ensure all engineering projects comply with relevant pharmaceutical industry regulations and standards, such as FDA, cGMP, and ISO.

· Ensure proper safety protocols are in place to protect employees and the environment.

· Provide CQV project management and technical engineering expertise throughout project lifecycle.

· Maintain detailed project documentation, including progress reports, change orders, and technical specifications.

· Coordination of all equipment documentation requirements.

· Liaise with Senior Engineering Manager, Equipment Vendor, Quality Leads, Validation Engineers, Operation Leads, Technology Leads, Maintenance technicians and Business Technology Technicians.

· Commissioning of equipment and engineering support during qualification.

Requirements:

· Bachelor's degree in Mechanical, Industrial, Manufacturing Engineering, or a related field.

· Minimum of 3 to 5 years’ experience.

· Previous experience in pharmaceutical manufacturing and a deep understanding of cGMP and FDA regulations.

· Strong project management skills with a track record of successful project delivery.

· Excellent communication and interpersonal skills.

· Knowledge of pharmaceutical production equipment and processes.

· Experience in commissioning and cycle development/Validation/startup would be an advantage.

· Problem-solving and analytical skills.

· Ability to work in a highly regulated and quality-focused environment.

What To Do Next:

Apply with your latest CV in strictest confidence and please indicate a time when you are free to be contacted. Alternatively, contact Juliana Tonetti directly on 0871733174 or @ juto@niras.com