Validation Engineer

Barry-Wehmiller • Indianapolis, IN

7d

About The Position

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm serving clients in food and beverage, life sciences, industrial, and advanced technology. The Validation Engineer joins the Regulatory Compliance Practice and works with technical experts and clients on capital projects and manufacturing solutions. The role develops and executes validation and FDA-compliance documentation and protocols for pharmaceutical equipment and processes, and may travel to client sites across the country. The position includes opportunities for professional development, mentorship, and career growth.

Requirements

• At least 7 years of project experience in pharmaceutical or medical-device environments.
• Bachelor of Science in Bioengineering, Biomedical Engineering, Chemical Engineering, or a related technical discipline.
• Strong technical writing and oral communication skills.
• Good communication and interpersonal skills, flexibility with tasks, and ability to interact with management, clients, and vendors at all levels.
• Ability to work independently and as a team member on a large project team.
• Strong computer skills, including Microsoft Office, Microsoft Project, and AutoCAD.
• Willingness and ability to travel as needed for project requirements.
• Understanding of ICH Q7 through Q11, 21 CFR Parts 210, 211, and 11, ISPE Baseline Guides, GAMP5, and ASTM E2500.

Responsibilities

• Establish user requirement specifications for critical equipment and systems.
• Assess risk across system functions and focus efforts on critical quality aspects.
• Develop and execute validation and FDA-compliance documents and protocols for pharmaceutical equipment and processes, including process equipment, facilities and utilities, and cleaning and processes.
• Work with teams to investigate and troubleshoot validation issues.
• Analyze qualification data and recommend corrective actions.
• Develop and perform impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverables.
• Prepare validation reports.
• Assist with project planning, scheduling, and coordination.
• Provide routine project status and communication updates to project leadership and clients.
• Travel to client sites as required for project work, including installation and startup activities, meetings, trainings, and industry events.

Benefits

• Professional development resources and mentorship, including the First-Year Experience program, Individual Development Plans, and Career Path resources and tools.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior