i-Pharm GxP · 1 day ago
Filling Line SME
Pennsylvania, United States
Contract
Hybrid
Senior Leveli-Pharm GxP is a global biopharmaceutical manufacturer delivering a filling line CAPEX project. The Filling Line SME Consultant will provide specialist support across equipment preparation, filling, inspection, and downstream readiness, ensuring efficient project delivery aligned with Annex 1 expectations.
Management Consulting
Hiring Manager
Haider Tanveer
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
Qualification
Required
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
Benefits
Reimbursed in line with standard project T&E policy
Company
i-Pharm GxP
Consulting Services to scope, staff, manage and deliver GxP solutions across North America, Europe and the Asia-Pacific.
Founded in 2014
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase