Computer System Validation (CSV) Consultants

Role: Computer System Validation (CSV) Consultants
Locations: Piscataway, NJ / Chicago, IL - 100% Onsite 5 Days/Week
Employment: Contract-to-Hire

• Strong hands-on Biotech CSV background is mandatory - 5+ years validating GxP computerized systems, with 21 CFR Part 11, GAMP 5, IQ/OQ/PQ, URS, traceability, risk assessments, and validation documentation. Pharma-only or medical-device-only candidates will not be considered.
• Must have experience validating lab instruments/manufacturing equipment and systems such as LIMS, SAP, or CMMS, working across Quality/IT/Lab/Manufacturing; must be willing to work 5 days onsite in Piscataway or Chicago and be open to contract-to-hire.

Position Overview

• Client is seeking Computer System Validation (CSV) Consultants to support validation activities within a highly regulated biotechnology environment.
• Candidates must have a strong, hands-on Biotech CSV background and experience validating laboratory, manufacturing, engineering, and enterprise computerized systems.
• Strong Biotech CSV experience is mandatory. Candidates with primarily pharmaceutical or medical-device CSV backgrounds will not be considered.
• The consultants will partner closely with Quality, IT, Laboratory, Manufacturing, and system owners to ensure computerized systems are appropriately validated and maintained in accordance with GxP and applicable regulatory requirements.

Responsibilities

• Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
• Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
• Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
• Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
• Support audits, inspections, CAPAs, deviations, and remediation activities related to computerized systems.
• Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
• Support validation activities involving Caliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.

Required Qualifications

• 5+ years of Computer System Validation experience within a GxP-regulated environment.
• Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments REQUIRED.
• Hands-on experience authoring and executing IQ/OQ/PQ protocols.
• Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
• Experience validating at least two of the following:
  • Laboratory instruments
  • Manufacturing/engineering equipment
  • LIMS
  • SAP
  • CMMS/calibration systems
  • Experience working cross-functionally with Quality, IT, Laboratory, Manufacturing, and technical SMEs.

• Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.