CSV Lead

Key Responsibilities: Serve as the designated Validation Lead and CSV approver for all validation deliverables, including validation plans, specifications, risk assessments, traceability matrices, qualification protocols, discrepancies, and validation summary reports. Own the risk-based validation strategy in alignment with GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, data integrity/ALCOA+ expectations, and CSV procedures. Own software categorization and configured library reuse decisions for the process control system, and determine with documented justification where supplier qualification, integrator FAT/SAT, and prior-deployment evidence may be leveraged within the risk-based testing strategy. Define the qualification approach for the DeltaV PCSD library, leveraging Emerson-provided standard library documentation and testing evidence for unmodified module classes, and requiring documented design, impact assessment, and risk-based testing for modified or custom library objects, with library version control maintained under change control. Participate in requirements, design, and risk assessment workshops, and govern change control and change impact/regression assessments so the validated state is maintained throughout implementation. Define and approve the integration qualification approach for data flows across process control, manufacturing execution, laboratory, and enterprise systems, and sequence integration testing against equipment availability and project milestones. Make and document release-readiness decisions, ensuring qualification evidence, open discrepancies, periodic review status, and training status support GMP use. Maintain alignment to the integrated project schedule, coordinate with the CQV workstream so CSV and equipment qualification activities are sequenced correctly, and elevate validation risks and schedule impacts to project leadership. Partner with Quality Assurance, Automation, Engineering, IT/OT Infrastructure, Manufacturing, System Owners, and service providers to resolve validation issues, and sustain validation ownership after go-live through periodic review and change control.

Required Qualifications: Bachelor's degree in engineering, Computer Science, Life Sciences, or a related technical discipline, with 15+ years of CSV experience in a GMP-regulated biopharmaceutical environment. Demonstrated experience as a Validation Lead and approver for GxP computerized systems through a full validation lifecycle, including greenfield or major capital projects. Hands‑on validation experience with DeltaV or comparable distributed control systems in GMP biologics manufacturing, including batch, recipe, phase, and ISA‑88 library qualification, and qualification of standard (e.g., Emerson PCSD) versus site‐modified libraries. Experience validating a manufacturing execution system, including electronic batch records, master batch record and recipe qualification, and review by exception. Working knowledge of GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU GMP Annex 11, and data integrity/ALCOA+ principles, with practical experience applying risk‑based testing and supplier leverage. Experience authoring, reviewing, and approving the full CSV deliverable set: validation plans, URS, FRS, design/configuration specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, discrepancies, and validation summary reports. Experience with electronic validation/document management platforms (Kneat, ValGenesis, or equivalent) and GMP change control systems. Strong written and verbal communication skills, with the ability to drive decisions across Quality, Automation, IT/OT, Engineering, and Manufacturing.