Commissioning & Qualification Engineer

The Role:

• Commissioning & Qualification Engineer
• Sligo
• Fully onsite role
• Permanent or Contractor Opportunity

Role Brief:

The successful candidate will be responsible for the coordination and management of all elements of commissioning & qualification of new and existing cleanroom facilities and automated medical device assembly equipment for a key NNIT Ireland client.

You will be tasked with developing a project plan and qualification strategy and time line in line with client requirements.

Core Responsibilities:

• Generation, Execution / Approval of Qualification Life Cycle documents from System Classification, P/GURS, Risk Assessments / FMEA through to IOQ and Final Summary Reporting for Direct Impact Systems.
• Generation of Commissioning Test documents for No Impact Systems.
  
• Implementation of Change Controls on the change management system to support project activities as applicable.
• Project activities may include but not are not limited to the following: Medical Device assembly equipment, Utilities, HVAC & Facilities.
  • Coordinate and supervise third party suppliers / vendors , service providers and sub-contractors as necessary.
  • Monitor and report on project plan progress, communicate any shortfalls in specific areas of the plan and where needed identify solutions to address the shortfalls.

Skills Brief:

• 3 or more years experience in a Commissioning & Qualification role in a pharmaceutical, biotechnology or medical devices GMP manufacturing environment is essential
• Generation, Execution / Approval of Qualification Life Cycle documents from System Classification, P/GURS, Risk Assessments / FMEA through to IOQ and Final Summary Reporting for Direct Impact Systems is essential.
• Exposure to the Commissioning & Qualification of Medical Device assembly equipment, Utilities, HVAC & Facilities amongst others is a requirement of the role.
• Strong project delivery and execution skills.
• Ability to work flexibly with the other members of project teams.
• Ability to organise and prioritise own workload and meet deadlines.
• Must be able to multi task and deal with regular interruptions and work scope execution.
• Good understanding of standards eg ISO, GMP/FDA Standards applicable to your tasks or project.

Person Brief:

Candidates must have a B.Sc. degree in Engineering or equivalent, with emphasis in software development, electrical, electronic or automation discipline, with a minimum of 3 years’ experience in industry, in a pharmaceutical, biotechnology or medical devices GMP manufacturing environment. The ideal candidate will have excellent communication skills and strong problem skills.

The role is fully onsite so you should be living in Sligo or within a commutable distance to the Sligo site or able to relocate within a short time frame and not requiring a new work permit application.

Opportunity Brief: 

This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry leading technology solutions. NNIT Ireland offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

Company Brief:

NNIT Ireland are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets.

Over the past 20 plus years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA.

We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.