Job Title: Equipment & Facility Qualification Engineer
Role Summary:
Join a cross-functional team delivering a medical device NPI project involving moulding and automated assembly equipment. The focus is on commissioning and qualification of cleanroom facilities and equipment, aligned with GMP and industry standards.
Key Responsibilities:
* Develop and execute qualification documents (URS, Risk Assessments, FMEA, IOQ, etc.).
* Coordinate FATs, commissioning, and facility/equipment qualification activities.
* Manage change controls and project documentation.
* Liaise with vendors, contractors, and internal stakeholders.
* Track project progress and escalate risks or delays.
* Contribute to project planning, reporting, and technical decisions.
Requirements:
* Degree in Engineering or related field.
* 3–5+ years’ experience in GMP-regulated environments (pharma/medtech).
* Strong knowledge of GMP, GAMP, ISO standards, and qualification lifecycle.
* Proficient in MS Office and Microsoft Project.
* Excellent communication and organisational skills.
* Flexible for occasional travel and out-of-hours global meetings.
* Self-starter with strong problem-solving and attention to detail.
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