Validation Engineer

Barry-Wehmiller • Carmel, IN

6d

About The Position

BW Design Group is hiring a Validation Engineer to join its Regulatory Compliance Practice and support pharmaceutical and medical-device clients. The role works individually and as part of project teams to support capital projects and implement solutions. The engineer develops and executes validation and FDA-compliance documentation and protocols for pharmaceutical equipment, processes, facilities, and utilities; travels to client sites across the country; and helps with manufacturing-process design, project management, and facility development. The position offers the opportunity to work with technical specialists and subject-matter experts on client projects while developing technical and leadership skills with support from professional-development resources and mentorship.

Requirements

• At least 7 years of project experience in pharmaceutical or medical-device environments.
• Strong technical writing and oral communication skills.
• Good communication and interpersonal skills, with flexibility across tasks and the ability to interact with all levels of management, clients, and vendors.
• Ability to work both as an individual contributor 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 necessary for project requirements.
• Bachelor’s degree in Bioengineering, Biomedical Engineering, Chemical Engineering, or a related technical field.
• 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, utilities, 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 communication and status updates to project leadership and clients.
• Travel as needed for project requirements, including installation and start-up activities, client meetings, company-sponsored meetings, training, 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