GerTEK Project Management & Technical Services is seeking to recruit an experienced Project Manager to join our team in Sligo.
Sligo Based
Capital Projects Manager – Medical Device Manufacturing
Role: Lead and manage capital projects within a medical device manufacturing environment, ensuring on-time, within-budget, and compliant delivery of new equipment, facility upgrades, and infrastructure improvements.
Responsibilities:
- Manage the full project lifecycle from initiation to close-out, including scope definition, budget development, scheduling, resource allocation, and risk management.
- Oversee the design, procurement, installation, and validation of capital equipment and facility modifications.
- Ensure projects adhere to relevant regulatory requirements (e.g., FDA, ISO 13485) and internal quality standards.
- Collaborate effectively with cross-functional teams including Engineering, Manufacturing, Quality, and Validation.
- Manage external vendors and contractors.
- Track project progress, report on key metrics, and proactively address potential issues.
- Develop and maintain project documentation.
Qualifications:
- Bachelor’s degree in Engineering or a related technical field.
- Proven experience (5+ years) managing capital projects within the medical device or a similarly regulated industry.
- Strong understanding of GMP, regulatory compliance, and validation processes.
- Excellent project management, communication, and stakeholder management skills.
- Experience with equipment procurement, installation, and commissioning.
- Familiarity with cost control and budget management.