Validation Consultant, Professional Services Details

Validation Consultant, Professional Services

Waters Corporation - Milford, MA

Employment Type : Full-Time

Overview: Waters Corporation's Professional Services Organization is comprised of highly skilled, motivated and customer focused professionals that partner with customers to ensure successful utilization of Waters’ product suite. As a Validation Consultant working for an industry leader, you will be committed to delivering Waters’ World Renowned service to our customers who utilize our scientific instrumentation and software. In this role, you will have the opportunity to provide (professional and/or technical) expertise on Waters' innovative product suite for multiple customer laboratories spanning across the Pharmaceutical & Life Sciences, Chemical Materials, Clinical, Food, Environmental, Forensics, Academia and Government industries.Responsibilities:

• Develop and author Computer System Validation (CSV) deliverables for regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts (IQ, OQ, PQ), Traceability Matrix, and Validation Reports.
• Write, review and approve documents to support computerized system processes.
• Perform quality review and approval of documents supporting computer system validation processes.
• Act as subject matter expert for relevant regulations of the FDA that govern the Pharamceutical industry (Part 11, 58, 211, 820), general regulatory expectations and industry trends in CSV.

Qualifications:

• BS/BA in Computer science, Life Sciences or related field of study
• Minimum of 5 years experience in developing and authoring computer systems validation deliverables for regulated applications
• Experienced working within a regulated environment for the Pharmaceutical and/or Medical Device industry
• Thorough knowledge of US CFR 21 Part 11, Part 58, Part 211, Part 820 regulations
• Experience in analytical or QC laboratories utilizing Empower 3 Enterprise and NuGenesis LMS is strongly preferred

Company Description: Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.

Key Words: Computer System Validation, validation, regulatory, compliance, Empower, NuGenesis, Quality