Filling SME

Purpose

Translate product and format strategy into technical and layout solutions for two filling lines (syringes and cartridges). Ensure Grade A/B environmental compliance, operational efficiency, and seamless integration with upstream/downstream systems.

Key Responsibilities / Scope & Decisions

• Define line architecture (isolators, de-nesting/nesting, checkweigh, stoppering/capping, reject management).
• Establish throughput, batch sizing, buffering, and sampling strategy.
• Specify environmental control requirements and EM inputs; ensure alignment with Contamination Control Strategy (CCS).
• Develop interfaces for component prep, peristaltic pump control, and supervisory systems (HMI/PCS/EMS).
• Support validation strategy and FAT/SAT planning.

Core Deliverables

• URS for two filling lines and associated ancillaries.
• Layouts with zoning, people/material flows, and RDS inputs.
• Utility & HVAC load lists; availability and changeover model.
• Outline validation strategy (FAT/SAT/IOQ split).

Experience & Qualifications

• 10+ years in sterile fill-finish operations or equipment design.
• Hands-on experience with isolator-based filling lines for syringes and cartridges.
• Familiarity with Annex 1, CCS, and aseptic filling standards.
• Degree in Engineering or Life Sciences.

Success Criteria

• No late layout changes due to overlooked flows or sampling needs.
• Timely approval of URS and layout deliverables.
• Qualified filling systems meeting throughput and sterility goals.