Automation of process modules (FTM Cytiva equipment)

Mission Details

Mission Title Automation of process modules (FTM Cytiva equipment)

Scope of Work The contractor will:

• Deploy and adapt Cytiva FTM equipment for vaccine production (ViceBio & Baculo)
• Write detailed functional analyses (Level 2)
• Identify gaps in existing process libraries
• Coordinate with Cytiva (international context, travel in Europe expected)
• Configure and commission manufacturing recipes (DeltaV Batch system)
• Support commissioning & qualification (C&Q) activities

Production Support

• Assist production teams during test batches:
  • October – December 2026
  • May require shift work (2x8 schedule)

Timeline & Deliverables

• April 1 – December 31, 2026 (project duration)

Key milestones:

• June 2026 → Functional analyses completed
• August 2026 → Recipe coding completed
• September 2026 → Recipes commissioned
• Oct–Dec 2026 → Production support during test batches

Organisation of the Assignment

Stakeholders Work will be carried out within a collaborative structure involving multiple engineering participants.

Execution Conditions

Location

• Work will mainly take place at the Neuville site
• May include access to production buildings
• Some work may occur at supplier locations

Working Hours

• Standard hours, but possible shift work:
  • Morning: 6:00 – 13:15
  • Evening: 12:45 – 20:00

Confidentiality

• A confidentiality agreement must be signed
• Each individual must commit to secrecy

Onboarding & Training Upon arrival, personnel will receive:

• Safety and GMP induction
• Training on procedures and document systems

Resources Sanofi provides:

• Workspace and IT equipment
• Access to internal systems Contractor provides:
• Personal protective equipment (PPE)

Quality / Safety / Environment Requirements include:

• Signing a prevention plan before starting
• Following site safety rules
• Wearing appropriate clothing and PPE
• Providing GMP training certification (renewed annually)

Additional requirements:

• Vaccinations (e.g. rabies, hepatitis A, flu)
• Immunity checks (rubella, measles, etc.)
• Basic electrical certification (non-electricians)

Mission Monitoring

• Regular reviews every 6–8 weeks
• Track progress and deliverables
• Report any deviations formally