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).

What You Will Do

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.

Why It Might Be a Fit

Strong analytical skills with keen attention to detail, ability to expertly read and interpret engineering drawings, P&IDs, and system diagrams, and strong written and verbal communication skills, including technical report writing.

Requirements

• 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.

Benefits

• Annual cash bonus program
• 401(k) plan with a generous company match
• Healthcare (including medical, dental and vision)
• Family building benefits
• Life and disability insurance
• Paid vacation
• Paid holidays
• Other paid leaves of absence
• Tuition reimbursement
• Support for caregiving needs