Senior Computer System Validation Analyst

Pay Range: $45.00hr - $50.00hr

Job Overview:

Our client is seeking a Computer System Validation Analyst to lead CSV compliance activities for capital and strategic projects within a regulated pharmaceutical environment.

Responsibilities:

• Lead Computer System Validation (CSV) compliance activities for capital and strategic projects.
• Develop, review, and approve validation lifecycle deliverables in accordance with applicable standard operating procedures (SOPs) and regulatory requirements, such as 21 CFR Part 11.
• Provide compliance guidance to project teams on Software Development Life Cycle (SDLC), Computer Software Assurance (CSA), qualification, and validation approaches.
• Participate in project meetings and CSV compliance reviews.
• Assist with project change controls and CSV compliance-related risk assessments.
• Maintain project CSV compliance trackers, metrics, and reporting.
• Approve SDLC documents as the technical unit.

Requirements:

• Minimum 5 years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), automation compliance, 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.
• Strong knowledge of Software Development Lifecycle (SDLC) processes.
• Strong knowledge of change management and deviation processes.
• Experience supporting capital projects and Good Manufacturing Practice (GMP) computerized systems.
• Strong stakeholder management and communication skills.
• Ability to work independently across multiple projects and sites.
• Ability to commute to the site in Rahway, NJ approximately three days per week.