The Role:Commissioning & Qualification EngineerSligoFully onsite rolePermanent or Contractor OpportunityRole 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, qualification strategy, and timeline in line with client requirements.
Core Responsibilities:Generation, execution, and approval of Qualification Lifecycle 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.Coordinate and supervise third-party suppliers, service providers, and subcontractors as necessary.Monitor and report on project plan progress, communicate shortfalls, and identify solutions to address them.Skills Brief:At least 3 years of experience in a Commissioning & Qualification role within a pharmaceutical, biotechnology, or medical devices GMP manufacturing environment.Experience in generating, executing, and approving Qualification Lifecycle documents for Direct Impact Systems.Exposure to commissioning and qualification of medical device assembly equipment, utilities, HVAC, and facilities.Strong project delivery and execution skills.Ability to work flexibly within project teams.Excellent organizational and prioritization skills.Ability to multitask and handle interruptions.Good understanding of standards such as ISO, GMP, and FDA standards.Person Brief:Candidates must hold a B.Sc.
degree in Engineering or equivalent, specializing in software development, electrical, electronic, or automation disciplines, with a minimum of 3 years' industry experience in a GMP manufacturing environment for pharmaceuticals, biotechnology, or medical devices.
Excellent communication and problem-solving skills are essential.
The role is fully onsite; candidates should reside in Sligo or within a commutable distance, or be willing to relocate quickly without requiring a new work permit.
Opportunity Brief:This is an excellent opportunity to work with global industry leaders, contributing to the development and enhancement of industry-leading technology solutions.
NNIT Ireland offers a supportive environment focused on employee development and wellness, along with a competitive compensation package.
Company Brief:NNIT Ireland specializes in Equipment System Integration and Support, assisting top multinational clients in the medical device and pharmaceutical sectors in achieving their Six Sigma and OEE targets.
Over the past 20+ years, we have grown from a Sligo-based enterprise into an international company with offices in Galway, Limerick, Leinster, and Florida, USA.
We pride ourselves on expertise in industrial IT integration and regulatory compliance, supporting global end users, OEMs, and technology providers.
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