In this role you support the Process Engineering Team to introduce new manufacturing processes for sterile injectable medicines, ensuring GMP and regulatory alignment. You collaborate on technical documentation, support tech transfer activities, and help prepare trial reports. You review shopfloor data and ensure analyses follow approved protocols and procedures. You participate in cross‑functional teams to shape the product introduction strategy for regulatory submission. This position offers hands‑on exposure to validation, documentation, and regulatory compliance within a global pharmaceutical environment.
- Issue and draft engineering and technical documents for manufacturing processes under validation
- Support tech transfer activities and extraction of information for trial reports
- Participate in project teams to discuss new product introduction strategies for regulatory submissions
- Support operational activities from a technical perspective
- Review shopfloor data and analyses in line with protocols and procedures
- Degree in Pharmacy, Chemistry, Biotechnology, Biology, Engineering or similar scientific xysqume discipline or consolidated experience
- Previous experience in pharmaceutical companies or tech transfer/validation is helpful
- Proficient English (written and spoken)
- Experience with company IT systems (PMX, LIMS, Trackwise, Minitab) and MS Office tools
- Excellent interpersonal skills, proactivity, and team orientation
📌 Process Engineer (Monza)
🏢 Experteer Italy
📍 Monza
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