Sterile Production Supervisor

TL;DR

Sterile Production Supervisor (Biologics manufacturing): Supervise day-to-day sterile biologics manufacturing operations and contribute to the design, implementation, and start-up of a next-generation sterile production department with an accent on GMP compliance (Annex 1), aseptic techniques, and contamination control. Focus on commissioning/qualification activities, operational workflow definition, and driving continuous improvement through deviations, investigations, and inspection readiness.

Location: Nerviano, Milano

Salary: €39.000 (minimum)

Company

Chiesi is an international research-focused biopharmaceutical group developing and marketing innovative drugs.

What you will do

• Participate in process and facility design discussions to ensure manufacturability and GMP compliance.
• Support layout review, equipment URS definition, and operational input during design and procurement.
• Take part in FAT/SAT, commissioning, and qualification for sterile biologics manufacturing lines.
• Supervise sterile biologics manufacturing operations (aseptic processing, filtration, filling, formulation) and ensure compliance with GMP and Annex 1.
• Lead operators in cleanroom behaviors, gowning practices, and aseptic techniques; monitor performance, deviations, and investigations.
• Support media fills, environmental monitoring oversight, and inspection readiness; promote quality and safety culture.

Requirements

• Degree in Biotechnology, Pharmacy, Biology, Chemical Engineering, or a related scientific discipline.
• Minimum 3–5 years of experience in sterile pharmaceutical manufacturing.
• Hands-on experience in biologics manufacturing (aseptic processing, sterile filtration, fill-finish, upstream/downstream interfaces).
• Knowledge of GMP and Annex 1 requirements.
• Strong understanding of aseptic techniques and contamination control strategy.
• Familiarity with process validation and equipment qualification; strong documentation and deviation management skills.

Nice to have

• Experience in start-up, scale-up, or facility expansion projects.
• Exposure to isolators, cleanroom qualification, and media fill execution.

Culture & Benefits

• Comprehensive benefits package including pension, private medical insurance, wellbeing programme, and flexible benefits.
• Healthcare programs and work-life balance initiatives.
• Relocation support and tax assistance services for foreign colleagues.
• Flexible working arrangements and remote work options.

Hiring process

• Interviews to assess experience in sterile biologics manufacturing, GMP/Annex 1 compliance, and start-up/qualification exposure.
• Discussion of fit for greenfield site start-up responsibilities and operational leadership expectations.