CSV and GxP Compliance Specialist

nex 11, and GAMP5-and ensuring Data Integrity within pharmaceutical and biotechnology GMP environments. The role also supports customers in aligning their system operations, validation activities, and data management practices with applicable regulatory standards.

The position requires approximately 80% domestic and international travel, and a strong customer-focused mindset, excellent technical capabilities, and problem-solving skills are essential for success.

As a member of the Waters Global Service Organization, you will gain valuable insight into our dynamic international service portfolio and stay engaged with the latest trends in laboratory informatics.

Responsibilities

Responsibilities

• Provide installation, configuration, implementation, and maintenance support for Waters Informatics solutions, including Empower and NuGenesis LMS.

• Support Waters next-generation cloud platform service deployment and operations.

• Conduct software qualification activities and deliver customer training.

• Perform technical consulting through analysis of customer architecture, infrastructure, and laboratory workflows.

• Deliver CSV (Computerized System Validation) services in accordance with regulatory requirements such as 21 CFR Part 11, EU Annex 11, and GAMP5 within pharmaceutical and biotechnology GMP environments.

• Analyze User Requirements Specifications (URS) and develop validation strategies, including the preparation of key validation documentation (e.g., Validation Plan, Configuration Specification, OQ/PQ protocols, Validation Summary Report, RTM).

• Support quality documentation activities, including Change Control, Deviation, and CAPA.

• Conduct Data Integrity assessments and recommend process improvements.

• Provide GMP, CSV, and Data Integrity training and workshops to customers and internal teams.

• Monitor updates to relevant regulatory guidelines and industry best practices and communicate key changes internally.

• Manage project schedules, risks, and stakeholder communication.

• Collaborate with Sales and Informatics Professional Services teams to develop proposals and technical documentation.

Qualifications

Qualifications

• Bachelor's degree or higher in a scientific or engineering discipline (Chemistry, Biology, Pharmaceutical Science, Computer/Industrial Engineering, or Quality-related fields preferred).

• Minimum 2-3 years of experience in GMP operations, CSV execution, QA, or manufacturing/quality systems within the pharmaceutical or biotechnology industry.

• Strong understanding of regulatory requirements such as 21 CFR Part 11, EU Annex 11, and PIC/S GMP.

• Experience with the GAMP5 V-model and the full validation lifecycle.

• Excellent technical writing and communication skills.

• Ability to manage project tasks and schedules effectively.

• Strong problem-solving skills and customer-facing communication abilities.

• Business-level English proficiency.

Preferred Skills & Experience

• Experience in operating or validating Chromatography software (eg, Empower, OpenLab, Chromeleon, Labsolution) or Lab workflow management system(LMS,LIMS,ELN,QMS, etc.).

• Experience with cloud-based laboratory solutions or strong interest in digital transformation in laboratory environments.

• Understanding of analytical instrument operations (e.g., LC/GC/MS) or general laboratory workflows.

• Experience with IT environments used in pharmaceutical settings, including network configuration and system operations.

• Working knowledge of server/client architecture, Citrix, VMware, and related IT infrastructure components.

• Practical experience working in QA/QC or Validation roles within pharmaceutical organizations.

• CSV experience related to large-scale system implementations or system upgrades.

• Experience in Data Integrity audit preparation or Risk Assessment.

• Experience in writing and executing IQ/OQ/PQ protocols.

• Completion of relevant CSV-related training (e.g., GAMP5 Fundamentals, Data Integrity Training).

• Experience leading projects or providing consulting services.

Competencies

• Strong customer focus and service mindset.

• Excellent analytical thinking and problem-solving capabilities.

• Effective project planning and management skills.

• Strong documentation and reporting abilities.

• Demonstrated team collaboration and communication skills.

• Ability to interpret complex validation requirements and translate them into actionable plans.

• Ability to perform effectively under time constraints and changing priorities.

• Self-directed learning ability and commitment to continuous professional development.

Company Description

Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business needs at the time.