Validation Engineer – CSV & Compliance (W2)

About the role

We are seeking an experienced Validation Engineer to support Computer System Validation (CSV) and compliance activities for capital and strategic projects within a regulated pharmaceutical or biotechnology environment. The role involves managing validation documentation, providing technical guidance on SDLC and Computer Software Assurance (CSA), supporting risk-based validation strategies, and ensuring GMP computerized systems comply with applicable regulatory requirements. The ideal candidate should have strong experience in CSV, validation lifecycle management, and regulatory compliance, with the ability to independently coordinate activities across multiple projects and work closely with Quality, Engineering, Automation, and Project Delivery teams.

Responsibilities

• Lead and support CSV compliance activities for capital projects, system implementations, upgrades, and strategic initiatives.
• Prepare, review, and approve validation lifecycle documentation, including Quality Assurance Plans (QAPs), risk assessments, requirements specifications, test protocols, and validation summary reports.
• Provide technical guidance to project teams on SDLC, CSA, qualification, and risk-based validation approaches.
• Review and approve SDLC deliverables from a technical compliance perspective, ensuring alignment with internal SOPs and applicable regulatory requirements.
• Support validation planning, execution, and compliance oversight for GMP computerized systems across manufacturing, laboratory, quality, and enterprise environments.
• Participate in project meetings, compliance reviews, and technical discussions to address validation requirements and project deliverables.
• Support change control activities, deviation investigations, risk assessments, and resolution of validation-related issues.
• Maintain validation schedules, compliance trackers, project metrics, and status reports to monitor progress and identify potential delays.
• Identify, document, and escalate compliance risks, validation gaps, and outstanding actions to project leadership.
• Support the implementation and improvement of validation procedures, SOPs, and compliance processes.
• Collaborate with Quality, IT, Engineering, Automation, and Project Delivery teams to ensure timely completion of validation activities.
• Provide compliance support during internal audits, regulatory inspections, and inspection readiness activities.

Requirements

• Bachelor's degree in Engineering, Computer Science