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CQV Engineer
Industry specialist
Gerard Cunniffe
Team Lead
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Athenry, County Galway, Ireland
€65 - €75 per hour
Contract
Job Title: CQV Lead Engineer
Location: Athenry, Ireland
Contract: 3 Month Fixed Term
Job & Company Overview:
Our client is a global leader in Medical Device Manufacturing working to transform how people manage their health. They are seeking a highly motivated and skilled CQV Lead Engineer to support the setup and validation of their new Greenfield manufacturing facility in Athenry. This is a 3-month contract role that will play a critical part in ensuring the successful construction, commissioning, and qualification of all facility, utility, and equipment systems.
This position involves two key phases:
Key Responsibilities:
Requirements:
For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
Location: Athenry, Ireland
Contract: 3 Month Fixed Term
Job & Company Overview:
Our client is a global leader in Medical Device Manufacturing working to transform how people manage their health. They are seeking a highly motivated and skilled CQV Lead Engineer to support the setup and validation of their new Greenfield manufacturing facility in Athenry. This is a 3-month contract role that will play a critical part in ensuring the successful construction, commissioning, and qualification of all facility, utility, and equipment systems.
This position involves two key phases:
- Construction & Commissioning Oversight – Managing and coordinating Construction Complete, Turnover, and Mechanical Completion through Commissioning in collaboration with the General Contractor (GC).
- Qualification Execution – Generating, executing, and approving Qualification documents for Direct Impact Systems (Facility, Utility, and Equipment).
Key Responsibilities:
- Lead and coordinate Construction Completion, Turnover, and Mechanical Completion activities.
- Oversee commissioning of all systems with the General Contractor (GC).
- Develop, execute, and approve IQ, OQ, PQ qualification protocols for direct impact systems.
- Work closely with cross-functional teams, including Engineering, Quality, and Operations, to ensure compliance with regulatory requirements.
- Identify and resolve commissioning and qualification challenges to maintain project timelines.
- Ensure adherence to GMP, FDA, ISO 13485, and other relevant regulations.
- Maintain detailed documentation of all CQV activities.
Requirements:
- Proven experience in CQV (Commissioning, Qualification, and Validation) within Medical Device or Pharmaceutical industries.
- Strong track record in large-scale campus delivery of greenfield projects.
- Expertise in Facility, Utility, and Equipment Qualification.
- Knowledge of cGMP, FDA, ISO 13485, and industry best practices.
- Strong project management and stakeholder coordination skills.
- Ability to problem-solve and drive tasks to completion in a fast-paced environment.
For a confidential conversation about the role please apply for the role or contact Gerard Cunniffe at gcunniffe@sterlingengineeringeu.com
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.
