Summary : We are seeking a CSV Engineer to lead Computer System Validation (CSV) compliance activities for capital and strategic projects in a regulated pharmaceutical or biotechnology environment. This role serves as the technical compliance authority for project teams, providing guidance on SDLC, CSA, qualification, and validation approaches, and authoring, reviewing, and approving validation lifecycle deliverables in line with applicable SOPs and regulatory requirements. The ideal candidate works independently across multiple projects and sites and partners closely with Quality, Engineering, Automation, and Project Delivery teams.
Roles & Responsibilities:
Lead CSV compliance activities for capital and strategic projects, maintaining compliance support coverage across assigned projects and sites.
Author, review, and approve validation lifecycle deliverables, including Quality Assurance Plans (QAPs), risk assessments, requirements, test documentation, and summary reports, in accordance with applicable SOPs and regulatory requirements such as 21 CFR Part 11, ensuring timely generation, review, and approval.
Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches, supporting the development of compliant validation strategies.
Approve SDLC documents as the technical unit and support successful execution of SDLC and validation activities across assigned projects.
Participate in project meetings, project governance, and CSV compliance reviews.
Assist with project change controls, deviations, and CSV compliance-related risk assessments.
Maintain project CSV compliance trackers, metrics, and reporting.
Track and communicate compliance risks and issues to the Global CSV Compliance Lead, working proactively to minimize project delays caused by compliance resource constraints.
Support SOP implementation and compliance initiatives.
Collaborate with Quality, Engineering, Automation, and Project Delivery teams to maintain compliance with internal procedures and applicable regulatory requirements.
Education & Experience :
Bachelors degree in Engineering, Science, Computer Systems, or a related discipline.
7+ years of experience in Computer System Validation (CSV), CSA, and automation compliance across shopfloor, enterprise, laboratory, and quality systems within a regulated pharmaceutical or biotechnology environment.
Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11.
Strong knowledge of risk-based validation and CSA principles and the Software Development Lifecycle (SDLC).
Working knowledge of change management and deviation processes.
Experience supportin
g capital projects and GMP computerized systems.
Strong stakeholder management and communication skills, with the ability to work independently across multiple projects and sites.
Numbers & Facts
Location
Rahway, NJ
Skills
Automationunmatched
Biotech and Pharmaceuticalunmatched
Capital Projectunmatched
Change Controlunmatched
Change Managementunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Scienceunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
Maintain Complianceunmatched
Metricsunmatched
Multitaskingunmatched
People Managementunmatched
Procedure Implementationunmatched
Project Controlunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Riskunmatched
Risk Analysisunmatched
Software Development Lifecycle (SDLC)unmatched
Standard Operating Procedures (SOP)unmatched
Strategic Planningunmatched
System Validationunmatched
Systems Engineeringunmatched
Technical Supportunmatched
Technical Writingunmatched
Test Requirementsunmatched
Time Managementunmatched
Writing Skillsunmatched
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