CSV Engineer III

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• Independently plan, author, and execute validation deliverables - validation plans, protocols (IQ/OQ/PQ), and summary reports - for automation and computerized systems in accordance with GAMP 5 and applicable cGMP requirements.
• Lead the qualification and lifecycle management of automated equipment and GxP computer systems (e.g., PLC, SCADA, DCS), including 21 CFR Part 11 and data integrity (ALCOA+) compliance.
• Serve as a technical advisor on validation strategy and risk-based approach across the facility, utility, process, and cleaning validation portfolio.
• Lead and coordinate validation studies and investigations with minimal supervision, applying independent technical judgment to resolve complex issues.
• Communicate project priorities, risks, and progress to the process team on a continuing basis.
• Identify and drive continuous-improvement opportunities in validation methodology, automation, and documentation practices.

• Prepare and review validation documentation, ensuring activities, actions, and results are accurate, complete, and audit-ready.
• Answer compliance and process questions from cross-functional partners and serve as a subject-matter resource during regulatory and internal audits.
• Initiate and document appropriate corrective action when process deviations or system non-conformances occur, escalating issues beyond established procedures as needed.
• Maintain validated state through change control, periodic review, and requalification activities.

• Provide technical coaching and guidance to less-experienced engineers and technicians on validation methodology and automation best practices.
• Build alignment across engineering, quality, and operations on validation requirements and acceptance criteria.
• May oversee and direct the validation activities of others within assigned projects.

• Demonstrated experience in validation or process engineering.
• Demonstrated ability to independently lead validation studies and projects from planning through execution with minimal supervision.
• Hands-on experience with automation and computer system validation (CSV).
• Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles.
• Ability to expertly read and interpret engineering drawings, P&IDs, and system diagrams.
• Strong analytical skills with keen attention to detail.
• Strong written and verbal communication skills, including technical report writing.
• Strong problem-solving abilities and sound independent judgment.
• Ability to prioritize and manage own time and workload across concurrent projects.
• Ability to coach peers and provide technical guidance to less-experienced team members.

• Bachelor’s degree in Engineering, Computer Science, or a related discipline.
• 5+ years of experience in validation or process engineering, including hands-on automation and computer system validation.
• Experience in a regulated or cGMP manufacturing environment.
• Familiarity with structured software development lifecycle (SDLC), configuration management, and scripting for automated and computerized systems.
• Hands-on experience with industrial automation platforms (e.g., Rockwell/Allen-Bradley, Siemens, or Emerson DeltaV PLC/SCADA/DCS) and data historians.
• Familiarity with automated testing tools and validation lifecycle management (VLM) software.

Work is performed in a combination of office, laboratory, and cGMP manufacturing environments. May require gowning and adherence to cleanroom, PPE, and safety requirements. Occasional lifting of up to…