Pharma Validation Engineer – FDA Compliance & Validation

Barry-Wehmiller Companies Inc.; Indianapolis (IN); On-site; USD 90,000 - 135,000; Full time

Job summary

Barry-Wehmiller Design Group in Indianapolis, IN is seeking a Validation Engineer III to join our Regulatory Compliance Practice. You will work on pharmaceutical equipment validation, risk assessments, and FDA compliance documentation to support capital projects.

You will travel to client sites, collaborate with engineers and project teams, and deliver validated, compliant solutions while developing as a world-class professional.

Qualifications

• Strong technical writing and oral communications.
• Ability to interact with all levels of management, clients, and vendors.
• Willing and able to travel as necessary for project requirements.
• Minimum of 7+ years project experience in the pharmaceutical or medical device environments.
• Understanding of ICH Q7 through 11, 21 CFR Parts 210, 211, ISPE Baseline Guides, GAMP5, and ASTM E2500.

Responsibilities

• Develop and execute validation and FDA compliance documents/protocols for pharmaceutical equipment.
• Travel to top clients across the country to assist in design and start-up activities.
• Establish user requirement specifications for critical equipment and systems.
• Assess risk across various aspects of systems’ functions and focus on critical quality aspects.
• Prepare validation reports and assist in project planning, scheduling, and coordination.

Skills

Strong technical writing

Communication skills

Interpersonal skills

Travel willingness

Teamwork

Project coordination

Education

B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering

Tools

Microsoft Office

AutoCAD

Microsoft Project

Job description

Barry-Wehmiller Design Group in Indianapolis, IN is seeking a Validation Engineer III to join our Regulatory Compliance Practice. You will work on pharmaceutical equipment validation, risk assessments, and FDA compliance documentation to support capital projects.

You will travel to client sites, collaborate with engineers and project teams, and deliver validated, compliant solutions while developing as a world-class professional.