Senior Validation Engineer

Barry-Wehmiller•Carmel, IN

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 Senior Validation Engineer joins the Regulatory Compliance Practice and works with technical specialists, subject matter experts, project teams, and clients to deliver consulting services and support capital projects. The role prepares and executes commissioning and qualification documents for pharmaceutical, biotech, and medical device utilities, facilities, and process equipment, applying industry best practices and a quality-focused consultant mindset. The position also supports client relationships and project delivery through clear communication and collaboration. The company describes professional development resources and mentorship, including a First-Year Experience program, Individual Development Plans, and Career Path resources and tools.

Requirements

At least 10 years of demonstrated experience with commissioning, qualification, and validation (CQV) of pharmaceutical, biotech, or medical device processes, systems, and equipment.
Experience developing and executing GMP lifecycle documentation in the life sciences industry, such as FAT, SAT, IQ, OQ, PQ, risk assessments, and URS.
Excellent organizational and leadership skills, including the ability to manage and execute multiple project responsibilities simultaneously.
Excellent communication and interpersonal skills, with the ability to interact with all levels of management, clients, and vendors.
Strong computer skills.
Willingness and ability to travel as required by project needs.
Bachelor’s degree in electrical engineering, mechanical engineering, chemical engineering, or an equivalent technical degree.

Nice To Haves

CQV experience in automation, packaging, cleaning, computer systems, utilities, and/or facilities.

Responsibilities

Prepare and execute commissioning and qualification documents for pharmaceutical, biotech, and medical device utilities, facilities, and process equipment.
Support capital projects and implement solutions for clients, working individually and in teams.
Communicate project status, technical questions, and concerns to project team leadership, both verbally and in writing.
Contribute to the delivery of technical consulting services and help strengthen relationships with clients and teams.
Travel as necessary for project requirements, including installation and start-up activities, client and company meetings, training, and industry events.