Sr CSV Engineer

Sr CSV Engineer at GxP Associates Sr CSV Engineer at GxP Associates in Denver, Colorado Posted in 3 days ago.

Type:

full-time

Job Description:

Senior CSV Engineer Location:

Denver, CO Work Type:

Onsite Start Date:

Within 2

Weeks of Offer Duration:

8-9 Months +

Possible Extensions Employment Type:

W2 Only Position Overview We are seeking an experienced Senior CSV Engineer to support validation activities within a regulated pharmaceutical/biotech manufacturing environment. The ideal candidate will have strong expertise in Computer System Validation (CSV), laboratory systems validation, and lifecycle documentation, with hands-on experience supporting

LIMS/SLIMS

platforms and GMP-regulated systems. This role will be responsible for executing and reviewing validation deliverables, ensuring compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 requirements while collaborating cross-functionally with Quality, IT, Validation, and Laboratory Operations teams. Key Responsibilities Lead and execute Computer System Validation (CSV) activities for laboratory and enterprise systems in GMP-regulated environments. Develop, review, and execute validation documentation including IOQ/PQ protocols, RTM (Requirements Traceability Matrix), QIRs, validation plans, and summary reports. Support validation and qualification activities for LIMS/SLIMS and other laboratory systems. Ensure systems comply with FDA, GxP, 21 CFR Part 11, and GAMP 5 guidelines. Coordinate with QA, IT, business users, and vendors to ensure successful implementation and validation of computerized systems. Manage deviations, discrepancies, and change controls related to validated systems. Support audits and inspections by providing validation documentation and compliance support. Required Qualifications 7-8 years of experience in Computer System Validation (CSV) within pharmaceutical, biotech, or regulated manufacturing environments. Strong hands-on experience with LIMS/SLIMS and laboratory systems validation. Experience authoring and executing IOQ/PQ documentation. Solid understanding of RTM, QIR, and validation lifecycle methodologies. Strong knowledge of FDA regulations, GxP, 21 CFR Part 11, and GAMP 5. Excellent communication and documentation skills. Additional Information Fully onsite role in Denver, CO. W2 candidates only. Immediate interview availability preferred. Strong extension potential based on project performance.