This is an exciting opportunity for Commissioning & Qualification Engineer to join a leading pharmaceutical company in Sligo. This role is on a fixed term 12 months contract.
Responsibilities:
- Prepare, execute, and obtain approval for Qualification Life Cycle documentation—including System Classification, Risk Assessments/FMEA, IOQ, and Final Summary Reports—for Direct Impact Systems.
- Develop project plans and qualification strategies in alignment with company's requirements.
- Coordinating and managing all aspects of commissioning and qualification for both new and existing cleanroom facilities and automated medical device assembly equipment.
- Implementation of Change Controls on the change management system to support project activities as applicable.
- Coordinate and oversee third-party suppliers, vendors, service providers, and subcontractors as needed.
- Track project progress against the plan, report any deviations, and propose solutions to address gaps or delays.
- Assess and recommend appropriate resource allocation to ensure timely completion of project tasks.
- If assigned a budget, monitor expenditures closely, report on financial commitments, forecast spending, and track progress accordingly.
Qualifications, Skills and Experience:
- 3 yrs experience in Equipment Qualification
- Knowledgeable in GMP Standards, ISO
- Experience with URS, Risk assessments, FATs documentation
For a confidential discussion and more information on the role, please contact Alicja Burchardt
alicja.burchardt@collinsmcnicholas.ie
0212427109