Quality Project Manager - Sterilization

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

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity.

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The Quality Project Manager – Sterilization is responsible for leading and executing sterilization‑related quality initiatives across manufacturing sites. This role combines strong sterilization technical expertise (EtO, steam, gamma) with structured project management capabilities to drive standardization, compliance, continuous improvement, and quality maturity. The position supports the development and implementation of standardized sterilization processes, validation programs, and QMS improvements while ensuring compliance with FDA, ISO 13485, and applicable regulatory standards. This role works cross‑functionally with Engineering, Operations, Regulatory, R&D, and Quality teams to execute projects on time, within scope, and within budget.

Essential Duties And Responsibilities

• Support the development, harmonization, and deployment of standardized sterilization procedures and quality practices across multiple sites.
• Coordinate sterilization validation activities, including initial process validations, revalidations, and annual re‑qualifications to maintain a validated state.
• Author, review, and approve sterilization protocols, validation reports, technical documentation, and related procedures in accordance with internal standards and regulatory requirements.
• Ensure compliance with FDA regulations (21 CFR 820), ISO 13485, applicable cGMP requirements, and other global regulatory standards.
• Support environmental monitoring programs and implement risk‑based validation and control strategies.
• Monitor, track, and trend sterilization process data to identify improvement opportunities, ensure process capability, and maintain compliance.
• Participate in regulatory inspections and audits and provide front‑room and back‑room support for sterilization‑related activities.
• Lead cross‑functional sterilization and quality improvement projects from initiation through closure, ensuring alignment with business objectives.
• Develop project charters, timelines, resource plans, and budgets, and identify, assess, and mitigate project risks throughout the project lifecycle.
• Manage project scope, schedule, and cost controls using structured project management methodologies.
• Assemble and coordinate cross‑functional project teams, define clear deliverables, and ensure accountability.
• Measure and report project performance using defined KPIs and quality metrics and communicate progress, risks, and outcomes to key stakeholders.
• Support standardization and continuous improvement of quality systems and sterilization practices across sites.
• Lead or contribute to CAPA, root cause analysis, FMEA, and broader risk management activities to address quality and compliance gaps.
• Develop, analyze, and report quality performance metrics related to sterilization effectiveness and cost of quality.
• Drive Lean and Six Sigma initiatives to improve sterilization cycle efficiency, strengthen compliance robustness, and optimize cost performance.
• Coordinate corrective and preventive actions resulting from customer complaints, audit findings, or operational nonconformances.
• Collaborate closely with Engineering, R&D, Operations, and Regulatory teams to support product and process transfers, validations, and continuous improvements.
• Support evaluation and implementation of new sterilization technologies, industry best practices, and process enhancements.
• Ensure proper change control processes are followed, including completion of risk assessments, impact analyses, and FMEA documentation.

Additional Responsibilities

• Works independently with minimal guidance.
• Develops technical knowledge, requires working knowledge and experience in project management.
• Manages single workstreams locally/globally and may work across multiple workstreams.
• Maintain clear communication paths with stakeholders.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

Education

• Bachelor's Degree Science related field, Chemistry, Biology, engineering required

Work Experience

• Preferred previous ETO, steam/gamma sterilization experience
• 3+ years experience in a similar position within the manufacturing industry
• Good knowledge of LEAN and 6 sigma manufacturing principles
• Very good organizational and project management skills
• Excellent communication skills and ability to successfully collaborate with teams across different countries and organizational levels
• Highly analytical and structured way of working
• Self-motivated, results- and solution-oriented personality

Preferred Knowledge, Skills And Abilities

• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation
• Maintain an awareness of “state of the art” technology as it applies to our industry. Take part in educational programs pertinent to process projects
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications
• Experience working with ISO13485, FDA and cGMP preferred
• Understanding and experience in use of Lean manufacturing principles preferred
• Ability to write routine reports, correspondence, and process documents
• Excellent organizational and communication skills.
• Works independently with minimal guidance
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification preferred

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.