CSV Engineer III

The CSV Engineer III independently plans, executes, and leads validation activities across facility, utility, process, cleaning, automation, and computer systems, with deep specialization in automation and computer system validation (CSV). Working within the process team concept, the role applies independent technical judgment to resolve complex validation challenges, requires no instruction on routine work, and partners across engineering, quality, and operations to keep systems compliant and inspection-ready. As a technical advisor to the validation function, it coaches less-experienced team members and builds alignment on validation strategy and approach.

• 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.

Documentation & Compliance

• 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.

Leadership, Coaching & Mentorship

• 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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Physical & Work Environment

• 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 25 lbs and the ability to stand, walk, and access equipment on the manufacturing floor for extended periods.
• May require work outside standard business hours to support production schedules, shutdowns, or time-sensitive validation activities.

Work Schedule

8 hours - Monday- Friday with the need of some flexibility
The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship or support for work authorization, including visas, is not available for this position.