Validation Engineer

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients' lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary : Design and prepare all protocols and reports related to validation activities with a focus on cleaning, equipment, utilities, and software validation.

Essential Duties and Responsibilities :

• Write, execute, and approve validation and re-validation protocols and reports for the validation of new and existing processes, equipment, systems, etc.
• Write summary reports, following good documentation practices.
• Write and revise SOPs as part of process improvements.
• Analyze statistical data to verify acceptable criteria.
• Develop testing strategies and rationale for equipment / systems.
• Provide technical support / troubleshooting for process and equipment issues.
• Attend production and team meetings, as required.
• Critically review complex data to ensure completeness, accuracy and compliance.
• Maintain close contact with Production, Facilities Maintenance, and Laboratory Services to assure effective communication on validation issues.
• Support regulatory services with CMC preparation, product reviews and Client and Regulatory audits.
• Assist in cleaning validation activities and plans associated with projects at the site.
• Keep manager advised of work status, workload, problems, and progress as related to work assignments. Prepare project plan, schedule, budget, and interim reports.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Other duties as assigned.

Education and Experience :

Knowledge, Skills and Abilities :

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and / or a pre-employment drug screening.

About the company

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products.

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