Validation Engineer

Validation Engineer (Design Group)

Join one of our 45 offices in the US, be part of a committed team of over 1500 professionals and work directly with clients in capital projects, remediation, change management, and regulatory compliance. In this role you will help deliver high‑quality solutions, ensuring accuracy and consistency across life‑science projects.

• Work individually and in teams to support capital projects, remediation efforts, and change management for our clients.
• Assist in the development of new programs, best practices, and program implementation for industry’s biggest names and technology‑driven companies entering into commercial manufacturing.
• Deliver Commissioning and Qualification (C&Q) solutions and services for client facility, utility, process, and equipment.
• Develop and execute a variety of validation and FDA compliance related documents/protocols.
• Author specifications, assessments, and test protocols across a diverse life‑science market (Pharmaceuticals, Biotechnology, Cell & Gene Therapy, Medical Device).
• Assist in the development and implementation of Quality Management System (QMS) procedures in harmony with regulatory standards such as ICH Q1, CFR 21 Part 210 and 211, CFR 21 Part 820, ICH Q8, ICH Q9, ICH Q10, and 21 CFR Part 11.
• Collaborate with teams to perform investigations, diagnose problems, and troubleshoot validation issues.
• Prepare detailed written validation reports.
• Communicate progress to project stakeholders and manage project deliverables to agreed schedule and scope.
• Travel as necessary for project requirements, including installation, start‑up, client meetings, training, and industry conferences.

• Passion for a career in the life‑science industry.
• Excellent communication and interpersonal skills; ability to interact with all levels of management, clients, and vendors.
• Bachelor’s degree in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical field (preferred).
• Project experience in a cGMP environment (pharmaceutical, biotech, or medical device facility).
• Experience authoring and executing validation protocols for automation/computerized systems, QC laboratory equipment, packaging systems, and/or utilities and facilities.
• Proficient computer skills (Microsoft Office, Microsoft Project, AutoCAD).
• Strong written and verbal technical communication, including report generation and presentation.
• Willingness and ability to travel as required.

Barry‑Wehmiller is an equal opportunity employer. M/F/D/V. This organization uses E‑Verify. Applicants may be subject to pre‑employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.