CSV Site Lead

CSL • Kankakee, IL

5d • $138,000 - $164,000

About The Position

The CSV Site Lead is accountable for developing and governing the Computerized System Validation (CSV) strategy for site Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories. Operating primarily through an external partner model, this role ensures that operational and Tier 2/3 CSV planning, resourcing and delivery are effectively executed, the validated state of OT systems is maintained across their lifecycle, and site practices align with quality, data integrity, and regulatory expectations. The CSV Site Lead provides governance, expertise, and oversight to the site automation teams and partners, ensuring robust digital and vendor QMS controls, inspection readiness, and sustainable CSV capability across the site. Role that this position reports to: Site Automation Head Role/s that report to this position: This role is an individual contributor who leads external CSV partners

Requirements

• Bachelor of Science in an Engineering, Automation, Computer Science or local equivalent.
• 7+ years experience with CSV methodologies in operation IT, OT, and Automation position with a good understanding of pharma, biotechnology, chemistry, and food industries.
• Demonstrated knowledge and experience with CSV regulations and SDLC guidelines for life-sciences and related best practices for compliance and risk based approach.
• Experience with Lab, Automation and MES projects and computer validation methodologies.
• Experience in writing, reviewing and executing CSV documentations (IQ, OQ, PQ) and CSV inspection readiness preparations and/or directly support regulatory agency inspections.
• Exposure to Execution Systems technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control, workflow, database applications, and interfaces to ERP, LIMS, etc.
• Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
• Demonstrated experience defining and implementing a CSV partner model in a regulated space.
• Automation & Execution Systems Expertise
• Working knowledge of software development lifecycle (SDLC) model and validation practices of various computerized systems
• Project Management
• Regulatory Compliance
• Contingent & Partner model Leadership & Development
• Strategic Planning
• Continuous Improvement & Innovation
• Stakeholder Engagement
• Strategic innovation
• Delivering Enterprise Results and Value Orientation

Responsibilities

• CSV Strategy, Governance, and Partnered Delivery (Tier 2/3) Define and own the site CSV strategy for OT systems (Manufacturing and Labs), ensuring alignment with global CSV, Quality, and Digital/OT standards. Govern operational and Tier 2/3 CSV planning, resourcing and delivery via external partners, including scope definition, resource alignment, and prioritization across operational and project portfolios. Establish clear RACI and working ways-of-working with site automation teams, Quality, and external partners to ensure consistent CSV execution and decision-making. Monitor partner performance against agreed SLAs/KPIs for CSV activities, driving continuous improvement in quality, timeliness, and compliance. Provide SME support and guidance in budgeting cycles according to upcoming resourcing requirements.
• Maintenance of Validated State for OT Platforms Ensure local OT platforms (PCS/MES) remain in a validated state throughout their lifecycle. Oversee change control, impact assessments, and validation strategies for system upgrades, patches, configuration changes, and new integrations. Partner with site automation and Quality to ensure deviations, incidents, and CAPAs related to CSV/OT systems are properly investigated, documented, allocated, and closed on time. Implement governance routines and dashboards to proactively track validated state, CSV risks, and remediation plans across site OT assets.
• CSV Framework, SOPs, Templates, and Methodology Own and maintain site CSV procedures, work instructions, templates, and tools for OT systems, ensuring alignment to global standards and current regulatory expectations. Govern standardized CSV deliverables (risk assessments, validation plans, test scripts, traceability, reports) for OT platforms to drive consistency across partners and projects. Provide guidance and coaching to site automation teams and partners on CSV methodology (risk-based validation, GAMP5, data integrity) to build sustainable capability. Periodically review and update CSV documentation to reflect lessons learned, audit/inspection outcomes, and emerging best practices.
• Vendor QMS Governance Define expectations and governance for vendor/partner QMS integration (e.g., documentation standards, testing practices, release criteria) to ensure traceability and compliance. Review and approve critical partner CSV deliverables and QMS records supporting OT changes and implementations, ensuring they meet site and regulatory requirements. Collaborate with Quality and Procurement to support vendor qualifications, audits, and ongoing performance reviews related to CSV and OT lifecycle management.
• Regulatory, Audit, and Data Integrity Support Serve as the site CSV/OT SME for regulatory inspections, internal audits, and customer audits, providing evidence, narratives, and documentation storyboards as required. Ensure CSV approaches for OT systems are fully aligned with data integrity principles and that technical and procedural controls are documented and effective. Lead or support remediation programs resulting from audit/inspection findings related to CSV, OT data integrity, or computerized systems. Maintain inspection readiness by driving routine self-assessments, gap analyses, and mock audit activities for OT computerized systems.
• Cross-Functional Collaboration and Capability Building Partner with site Automation, QC, Manufacturing, Quality, I&T, and Global CSV teams to ensure integrated CSV approaches across projects and operations. Provide training and awareness sessions on CSV expectations, roles, and responsibilities for site teams and partner resources involved in OT system lifecycle activities. Act as the primary CSV governance interface between the site and global CSV forums, ensuring bi-directional feedback and alignment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees