Job & Company Overview:
Our client is a global leader in Medical Device Manufacturing. They are seeking a highly motivated and skilled CQV Lead Engineer for a 12-month contract role that will play a critical part in ensuring the successful commissioning and qualification of all facility, utility, and equipment systems.
This position involves two key phases:
* Commissioning Oversight – Managing and coordinating Completion, 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 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 facility delivery 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.
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.
For more information and a confidential chat please contact Niall Finnerty on +35386 1980270/ NFinnerty@sterlingengineeringeu.com
Seniority level
Not Applicable
Employment type
Contract
Job function
Engineering and Quality Assurance
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr