Process Engineer
On-siteEste, Veneto, Italy
Job Summary
Lead engineering projects including new product introductions, technology transfers, and process improvements while designing, documenting, and optimizing manufacturing processes. Analyze yield, OEE, cycle time, and downtime data to identify improvement opportunities, perform root cause analysis, and support corrective and preventive actions. Develop validation strategies for equipment, systems, and utilities; create, execute, and approve documentation for IQ, OQ, PQ, and process validation. Ensure compliance with FDA, GMP, and ISO standards by reviewing engineering documentation and supporting change control, deviations, and CAPA initiatives. Coordinate activities with operations, suppliers, and cross-functional teams to track project schedules, deliverables, and technical milestones.
Required Qualifications
- Bachelor's degree in Engineering
- 3–5 years of engineering experience in the Pharmaceutical or Medical Device industry
- Experience supporting engineering operations in a regulated environment
- Fully bilingual in English and Spanish
Desired Qualifications
- Multi-site project experience
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