3 days ago Be among the first 25 applicants
Dillon Engineering Services provided pay range
This range is provided by Dillon Engineering Services. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Job Title:
CQV Lead Engineer
Location:
Athenry, Ireland
Contract Duration:
12 months
About the Role:
We’re looking for an experienced CQV Lead Engineer to play a key role in the setup, commissioning, and validation of a brand-new Greenfield manufacturing facility in Athenry. This is a high-impact role focused on ensuring the successful delivery of all facility, utility, and equipment systems—on time and to the highest standards.
Project Phases Overview:
* Construction & Commissioning: Lead the oversight of Construction Complete, Turnover, and Mechanical Completion phases in close partnership with the General Contractor (GC).
* Qualification Execution: Prepare, execute, and approve qualification protocols for all Direct Impact Systems, including Facility, Utility, and Equipment.
Key Responsibilities:
* Coordinate and lead all activities related to Construction Completion, Turnover, and Mechanical Completion.
* Oversee system commissioning in collaboration with the General Contractor.
* Develop and manage system risk assessments and traceability matrices.
* Create, execute, and approve IQ, OQ, and PQ protocols for all Direct Impact Systems.
* Prepare Installation Verification Testing (IVT) and Functional Performance Testing (FPT) documentation, aligning with GC commissioning templates.
* Work cross-functionally with Engineering, Quality, and Operations teams to ensure compliance with regulatory and project requirements.
* Proactively identify and resolve CQV issues to keep the project on schedule.
* Ensure full compliance with GMP, FDA, ISO 13485, and other applicable standards.
* Maintain accurate and comprehensive documentation of all CQV activities.
Requirements:
* Demonstrated experience in CQV within the Pharmaceutical or Medical Device industries.
* In-depth knowledge of Facility, Utility, and Equipment qualification processes.
* Strong understanding of cGMP, FDA regulations, ISO 13485, and industry best practices.
* Excellent project management skills and experience working with multiple stakeholders.
* Strong problem-solving abilities and a proactive, hands-on approach.
Seniority level:
Mid-Senior level
Employment type:
Contract
Job function:
Quality Assurance, Engineering, and Management
Industries:
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
#J-18808-Ljbffr