Senior Computer Systems Validation Engineer – FDA/Pharma

Barry-Wehmiller Companies Inc.; Indianapolis (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

BW Design Group in Indianapolis, IN is seeking a Computer Systems Validation Engineer to support FDA-regulated projects. You will prepare validation documents, develop test scripts, and ensure CQV compliance across distributed control, process control, and stand-alone systems.

You will apply GAMP5, cGMP, and ALCOA+ principles while collaborating with clients to deliver high-quality validation deliverables and strengthen project outcomes.

Qualifications

• Bachelor's degree in engineering, computer science, or related field.
• 5+ years of computer systems validation experience in FDA-regulated industries.
• Working knowledge of GAMP5 and 21 CFR Part 11 requirements.
• Ability to travel for project requirements, including installations and client meetings.
• Solid understanding of ALCOA+ principles.

Responsibilities

• Prepare and execute computer systems validation documents for distributed control, process control, and stand-alone production systems.
• Develop and execute validation test scripts, including IQs, OQs, SFATs, HFATs, and traceability matrices.
• Apply cGMP, FDA CQV methods, and good documentation practices throughout validation deliverables.
• Review engineering documents, set priorities, and manage validation activities across multiple projects.
• Collaborate with clients and project teams to communicate technical findings, deliverable status, and project needs.

Skills

GAMP5

21 CFR Part 11

IQ/OQ/SFAT/HFAT

Documentation practices

cGMP

Education

Bachelor's degree in engineering or CS

Tools

Emerson DeltaV

Syncade

Allen-Bradley PLC

Wonderware

OSI PI

Rockwell Software

Job description

BW Design Group in Indianapolis, IN is seeking a Computer Systems Validation Engineer to support FDA-regulated projects. You will prepare validation documents, develop test scripts, and ensure CQV compliance across distributed control, process control, and stand-alone systems.

You will apply GAMP5, cGMP, and ALCOA+ principles while collaborating with clients to deliver high-quality validation deliverables and strengthen project outcomes.