Job Title: Validation Engineer x 2

Contract Duration: 6 months each

FBR: 60.00*

Pay Parity: 57K

Site/Location: Westport

Hiring Manager: Brian Clarken

Interviews: 1-2 rounds depending on calibre of candidates, virtual/onsite

*Because these are only 6 month contracts, Brian will be open to level of experience (junior to mid-level).  Job title will be ‘Validation Engineer II’ with a max rate card of FBR 68.69; however, the manager’s max FBR will be 60.00 so this is the initial figure you work with.  Candidate’s must be aligned with their level of experience so junior candidates would be expected to have a lower FBR, ideally looking at between FBR 52.00-60.00.

Job Description is attached.  Can you please start to pipeline candidates for submission.

• 2 x 6 month contracts (subject to renewal review depending on business requirements at the time)
• 100% onsite initially whilst person is being trained and settling in, at least 3 days onsite thereafter depending on project focus and regulatory audits (during which 5 days onsite will be required)
• Role not eligible for overtime/doubletime, any additional hours will be requested by AbbVie and the time will be given back (time in lieu).
• Joining a team of 5-8 other Engineers reporting to either Validations Manager or Technical Operations Manager.
• These positions will support upcoming regulatory inspections.  Depending on candidates expertise they will either directly support remediation works in preparation for these inspections or they will backfill for current project based engineers to free them up to support these works. 
• With that in mind expertise in the relevant subject matter areas would be required – Equipment Validation (very relevant) , Aseptics (Sterilisation Validation), Facility Validation, Process Validation, Cleaning Validations, CSV, Automation etc.  all will be relevant.

Top skills required:

1. Ability to plan and schedule
2. Problem solving/critical thinking
3. Ability to work independently
4. Ability to work as part of a Project Team
5. Excellent technical writing

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