Process Engineer

Experteer Italy; Monza; On-site; EUR 42,000 - 62,000; Full time

Job summary

Experteer Italy is seeking a Process Engineer to support the Process Engineering Team in introducing new manufacturing processes for sterile injectable medicines. The role ensures GMP and regulatory alignment, collaborates on technical documentation, and supports tech transfer activities and trial reports.

You will review shopfloor data and ensure analyses follow approved protocols, contributing to regulatory submissions in a global pharmaceutical environment.

Qualifications

• Degree in Pharmacy, Chemistry, Biotechnology, Biology, Engineering or related field.
• Experience in pharmaceutical industry or tech transfer/validation is helpful.
• Proficient in English (written and spoken).
• Experience with PMX, LIMS, Trackwise, Minitab and MS Office.

Responsibilities

• 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

Skills

English proficiency

Interpersonal skills

Proactivity

Team orientation

Regulatory knowledge

Education

Science degree (Pharmacy, Chemistry, Biotechnology, Biology, Engineering)

Tools

PMX

LIMS

Trackwise

Minitab

Job description

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 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