Validation Engineer

Barry-Wehmiller•Clearwater, FL

About The Position

BW Design Group is hiring a Validation Engineer II to join its Regulatory Compliance Practice. The role supports capital projects and client solutions, working both independently and with teams alongside technical specialists and subject matter experts. The engineer will develop and execute validation and FDA-compliance documentation and protocols for pharmaceutical equipment, and travel to client sites across the country to support manufacturing-process design, project management, facility development, installation, and start-up activities. The position includes developing and executing FAT, SAT, IQ, and OQ documentation for automated systems in the pharmaceutical industry; supporting quality management system procedures and applicable ICH and CFR requirements; assisting teams with investigations and troubleshooting; and preparing written validation reports. The role offers professional development and mentorship resources, including the First Year Experience program, Individual Development Plans, and Career Path resources and tools.

Requirements

Bachelor of Science in Bioengineering, Biomedical Engineering, Chemical Engineering, or a related technical field.
Good communication and interpersonal skills.
Flexibility with tasks and ability to interact with all levels of management, clients, and vendors.
Strong technical writing and oral communication skills.
Strong computer skills, including Microsoft Office, Microsoft Project, and AutoCAD.
Willingness and ability to travel as necessary for project requirements.

Nice To Haves

At least 3 years of project experience validating automation, packaging, utilities, and/or facilities.
At least 3 years of project experience in pharmaceutical or medical device environments.

Responsibilities

Support capital projects and implement solutions for clients, individually and as part of a team.
Develop and execute validation and FDA-compliance documents and protocols for pharmaceutical equipment.
Develop and execute FAT, SAT, IQ, and OQ documentation for automated systems in the pharmaceutical industry.
Assist in developing and executing QMS procedures and work related to ICH Q1 stability protocols and reports, CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10.
Work with teams to investigate and troubleshoot validation-related issues.
Prepare written validation reports.
Travel to client sites for project requirements, including installation and start-up activities, client meetings, and other business or industry events.