Sterilization Quality Project Lead (Hybrid)

RXinsider LTD.; Exton (PA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

West Pharmaceutical Services, Inc. is seeking a Quality Project Manager – Sterilization to lead sterilization quality initiatives across manufacturing sites.

The role blends deep sterilization expertise (EtO, steam, gamma) with structured project management to drive standardization and compliance. You will work cross-functionally with Engineering, Operations, Regulatory, R&D, and Quality to deliver projects on time, within scope and budget, ensuring regulatory alignment and continuous quality

Qualifications

• Bachelor's Degree in Science related field (Chemistry, Biology, Engineering).
• 3+ years in a similar role within manufacturing.
• LEAN and Six Sigma knowledge.
• Strong organizational and project management skills.
• Excellent communication and collaboration across countries.
• Analytical and structured approach.
• Self-motivated and results-oriented.

Responsibilities

• Develop standardized sterilization procedures across sites.
• Coordinate sterilization validation activities (initial, revalidations, re-qualifications).
• Prepare sterilization protocols and validation reports in line with regulatory standards.
• Ensure FDA/ISO13485 and cGMP compliance across sites.
• Support environmental monitoring and risk-based validation strategies.
• Monitor sterilization data to identify opportunities and ensure process capability.
• Lead cross-functional sterilization improvement projects from initiation to closure.
• Develop project charters, timelines, budgets, and risk management.

Skills

EtO Sterilization

Steam Sterilization

Gamma Sterilization

Project Management

Lean Six Sigma

Regulatory Knowledge

Cross-functional Collaboration

Quality Systems

Documentation

Education

Bachelor's Degree in Science/Engineering

Tools

SAP

MS Office

Job description

West Pharmaceutical Services, Inc. is seeking a Quality Project Manager – Sterilization to lead sterilization quality initiatives across manufacturing sites.

The role blends deep sterilization expertise (EtO, steam, gamma) with structured project management to drive standardization and compliance. You will work cross-functionally with Engineering, Operations, Regulatory, R&D, and Quality to deliver projects on time, within scope and budget, ensuring regulatory alignment and continuous quality