Computer Systems Validation (CSV) Consultan

 

Computer Systems Validation (CSV) Consultant – Biologics Project

 

Remote – East Coast U.S. preferred
Candidates must be able to work primarily within Eastern Time business hours. Limited travel to client or manufacturing sites on the East Coast may be required.

 

Contract / Project-Based
Full-time hours preferred for project duration

 

 

We are seeking an experienced CSV Consultant to support a biologics program in a GxP-regulated environment. This role will lead and execute validation deliverables for systems used across manufacturing, quality, laboratory, and supporting business functions. The ideal candidate has strong experience with computer system validation in biotech or pharmaceuticals, with direct exposure to biologics operations, quality systems, and regulatory expectations.

 

The CSV Consultant will be responsible for planning, authoring, reviewing, and executing validation lifecycle documentation for GxP systems supporting a biologics project. This individual will partner with Quality, IT, Manufacturing, Validation, Engineering, and business stakeholders to ensure systems are implemented and maintained in compliance with internal procedures and regulatory requirements.

Key Responsibilities

• Lead CSV activities for GxP systems supporting biologics development, manufacturing, QC, QA, and supply chain functions.
• Author and/or review validation lifecycle documents, including:
  • Validation plans
  • Risk assessments
  • User requirements specifications
  • Functional and design specifications
  • IQ/OQ/PQ or equivalent test protocols
  • Traceability matrices
  • Summary reports
  • SOPs and work instructions
• Support implementation and validation of systems such as:
  • MES
  • LIMS
  • QMS
  • EDMS
  • ERP interfaces
  • Laboratory instruments/software
  • Manufacturing automation or data systems
• Ensure validation approach aligns with GAMP 5, 21 CFR Part 11, data integrity principles, and applicable GxP requirements.
• Perform impact assessments, periodic reviews, and change control assessments for validated systems.
• Coordinate testing activities, deviations, discrepancies, and remediation documentation.
• Partner with QA and system owners to support audit readiness and inspection support.
• Assist with vendor assessment documentation and leverage supplier documentation where appropriate.
• Support risk-based validation strategies and lifecycle maintenance of validated systems.
• Provide status updates, identify project risks, and drive deliverables to project timelines.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field
• 5+ years of CSV experience in biotech, biologics, or pharmaceutical environments
• Strong working knowledge of:
  • GxP compliance
  • FDA and global regulatory expectations
  • 21 CFR Part 11
  • Annex 11
  • Data integrity requirements
  • GAMP 5
• Experience validating systems used in biologics manufacturing or laboratories
• Hands-on experience authoring and executing CSV documentation
• Experience with deviation management, change control, CAPA, and risk assessments
• Ability to work cross-functionally with QA, IT, and business stakeholders
• Strong written communication and document authoring skills
• Able to manage multiple priorities in a remote project environment

Preferred Qualifications

• Direct experience supporting biologics manufacturing, process development, MSAT, QC labs, or fill/finish operations
• Experience with regulated platforms such as:
  • TrackWise
  • MasterControl
  • Veeva
  • LabWare
  • Empower
  • DeltaV
  • Syncade
  • SAP
  • Kneat
• Experience in startup, tech transfer, scale-up, or commercial readiness environments
• Familiarity with computerized asset lifecycle management and infrastructure qualification interfaces
• Prior consulting experience in client-facing project teams

Deliverables

• Approved validation strategy and plan
• Completed risk assessments and requirements documentation
• Executed protocol packages with documented results
• Traceability matrix and final validation summary report
• Change control and deviation documentation as needed
• Audit-ready validation file for applicable systems

Work Environment

• Fully remote role with collaboration across East Coast teams
• Must be available for meetings during standard Eastern Time hours
• Occasional travel may be required for workshops, testing, or go-live support