Validation Engineer II — FDA/Pharma Compliance

Barry-Wehmiller Companies Inc.; Indianapolis (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Barry-Wehmiller Design Group in Indianapolis is seeking a Validation Engineer II to support capital projects, developing validation and FDA-compliance documents for pharmaceutical equipment and processes.

You will collaborate with cross-functional teams, perform risk assessments, design qualification plans, execute protocols, and contribute to project planning and client communication.

Qualifications

• Minimum 3 years project experience in pharmaceutical or medical device environments.
• Strong technical writing and clear oral communication.
• Willingness to travel to client sites for installation and startup activities.
• Understanding of ICH Q7–Q11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, ASTM E2500.
• BS in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.

Responsibilities

• Develop and execute validation and FDA compliance documents for pharmaceutical equipment and processes.
• Assess risk, create qualification plans, and perform investigations and troubleshooting.
• Prepare validation reports and support project planning, scheduling, and client communication.

Skills

Communication skills

Interpersonal skills

Technical writing

Team player

Travel willingness

Education

BS in Bioengineering or related technical field

Tools

Microsoft Office

Microsoft Project

AutoCAD

Job description

Barry-Wehmiller Design Group in Indianapolis is seeking a Validation Engineer II to support capital projects, developing validation and FDA-compliance documents for pharmaceutical equipment and processes.

You will collaborate with cross-functional teams, perform risk assessments, design qualification plans, execute protocols, and contribute to project planning and client communication.