Sterile Process Engineer - Tech Transfer & Validation

Experteer Italy; Monza; In loco; EUR 42.000 - 62.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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

Conoscenze

English proficiency

Interpersonal skills

Proactivity

Team orientation

Regulatory knowledge

Formazione

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

Strumenti

PMX

LIMS

Trackwise

Minitab

Descrizione del lavoro

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.