United Pharma ยท 7 hours ago
Validation --(CSV Engineer)
California, United States
Contract
Onsite
Mid LevelUnited Pharma is seeking a CSV Engineer to manage and execute Computer System Validation deliverables for GMP manufacturing and laboratory systems. The role involves collaborating with cross-functional teams to ensure compliance with GxP regulations and maintaining accurate validation documentation.
Staffing & Recruiting
Hiring Manager
Chandra Sekhar.s
Responsibilities
Author, execute, and manage Computer System Validation (CSV) deliverables, including IQ/OQ/PQ protocols and 21 CFR Part 11 assessments , for GMP manufacturing and laboratory systems such as MES, LIMS, SCADA, PLCs, data historians, and automation platforms
Develop and maintain validation plans, risk assessments, traceability matrices, and final validation reports in alignment with site and global quality standards
Collaborate cross-functionally with Automation, IT, Manufacturing, and Quality teams to ensure proper system configuration, effective change management, and complete lifecycle documentation
Partner with vendors and system integrators to define and verify user requirements, functional specifications, and system design documentation
Ensure computerized systems are implemented and maintained in compliance with GxP regulations , FDA and EMA guidance , and data integrity principles (ALCOA+)
Support deviation investigations, CAPA execution , and continuous improvement initiatives related to system validation and compliance
Maintain accurate, audit-ready validation documentation in accordance with site SOPs and provide support during internal and external regulatory audits
Qualification
Required
Author, execute, and manage Computer System Validation (CSV) deliverables, including IQ/OQ/PQ protocols and 21 CFR Part 11 assessments, for GMP manufacturing and laboratory systems such as MES, LIMS, SCADA, PLCs, data historians, and automation platforms
Develop and maintain validation plans, risk assessments, traceability matrices, and final validation reports in alignment with site and global quality standards
Collaborate cross-functionally with Automation, IT, Manufacturing, and Quality teams to ensure proper system configuration, effective change management, and complete lifecycle documentation
Partner with vendors and system integrators to define and verify user requirements, functional specifications, and system design documentation
Ensure computerized systems are implemented and maintained in compliance with GxP regulations, FDA and EMA guidance, and data integrity principles (ALCOA+)
Support deviation investigations, CAPA execution, and continuous improvement initiatives related to system validation and compliance
Maintain accurate, audit-ready validation documentation in accordance with site SOPs and provide support during internal and external regulatory audits
Company
United Pharma
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry.
Founded in 2017
11-50 employees
H1B Sponsorship
United Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Early StageCompany data provided by crunchbase