Filling Line SME

Filling Line SME Consultant

Project Overview:

A global biopharmaceutical manufacturer is delivering a filling line CAPEX project involving two fillers:

• One vial filler

• One syringe filler

The lines will support non-lyophilized liquid fill within isolated operations. The role will provide specialist SME support across equipment preparation, filling, inspection, and downstream readiness, ensuring efficient project delivery aligned with Annex 1 expectations.

This project forms part of a wider network expansion and standardisation strategy. Multiple identical fillers have already been implemented across the organisation, with this being the final installation. The project will therefore leverage prior learnings while incorporating recent technology experience.

Why This Role Is Needed

• Internal filling SMEs who supported previous installations are now fully allocated

• Overlapping CAPEX projects have created a capacity gap

• External SME support is required to:

– Apply Annex 1 practically and proportionately

– Avoid over-engineering and unnecessary scope

– Challenge vendor-led solutions where appropriate

– Ensure efficient progression into CQV and operations

Key Responsibilities

• Provide hands-on SME input to a filling project involving dual fillers (vial and syringe) within isolated operations

• Support equipment preparation activities, including autoclaves and parts washers

• Support post-filling inspection activities, including semi-automated and fully automated visual inspection systems (SAVI and AVI)

• Provide practical input into design and execution decisions with awareness of downstream CQV impact, operational readiness, and schedule and cost implications

• Apply Annex 1 requirements pragmatically based on existing controls and risk

• Challenge vendor proposals involving unproven technologies, over-engineered solutions, or misaligned design assumptions

• Potential involvement in packaging activities post-inspection, depending on experience

Stakeholder Interaction

The consultant will operate as an embedded member of the project team and interface with:

• Filling and Operations stakeholders

• Engineering and design partners

• Equipment vendors

• CQV, QA, and Capital Project teams

Required Experience

• Recent, hands-on filling line experience within a GMP environment

• Strong experience with vial and syringe filling for non-lyophilized liquid products

• Experience working with isolator-based filling systems

• Working knowledge of autoclaves and parts washers

• Experience with visual inspection systems (SAVI and AVI)

• Practical, real-world Annex 1 experience with the ability to apply compliance proportionately

• Comfortable challenging unnecessary scope and vendor-led over-engineering

• Experience working within fast-paced CAPEX projects

• Confident collaborating with Engineering, CQV, QA, and Operations teams

Key Objectives – Initial Project Phase

• Rapid integration into the filling workstream

• Application of recent filling technology experience to support design and execution

• Ensure Annex 1 expectations are met without over-engineering

• Support efficient progression toward CQV and operational readiness

Working Model

• Hybrid working model

• 50% on-site / 50% remote

Travel and expenses

Reimbursed in line with standard project T&E policy