Validation Engineer II

Validation Engineer II

Position within BW Design Group's Regulatory Compliance Practice, responsible for developing and executing validation and FDA compliance documents for pharmaceutical equipment and processes.

• Develop and execute validation and FDA compliance related documents and protocols for pharmaceutical equipment and processes including Process Equipment, Facility / Utilities, and Cleaning / Process.
• Establish user requirement specification for critical equipment and systems.
• Assess risk across various aspects of system functions and focus on critical quality aspects.
• Perform investigations and troubleshoot validation related issues.
• Analyze qualification data and recommend corrective actions.
• Develop and perform impact assessments, traceability matrices, system risk assessments, and other risk‑based validation documentation deliverables.
• Prepare validation reports and assist in project planning, scheduling, and coordination.
• Provide routine communication and status updates to project leadership and clients.
• Travel to clients nationwide for project installation, start‑up, meetings, trainings, and industry events.

• Minimum of 3years project experience in the pharmaceutical or medical device environments.
• Good communication and interpersonal skills; flexible with tasks and ability to interact with all levels of management, clients, and vendors.
• Ability to work as an individual contributor and team player on large project teams.
• Strong technical writing and oral communication skills.
• Proficiency with Microsoft Office, Microsoft Project, and AutoCAD.
• Understanding of ICH Q7–Q11, 21
  
  CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME
  2500.
• BS in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.
• Willingness and ability to travel as required for project activities.

Barry‑Wehmiller is an equal opportunity employer. M/F/D/V. The organization uses E‑Verify. Applicants may be subject to pre‑employment screening including drug testing, reference checks, background screening, and skills assessments. Please let us know if you require reasonable accommodations during the interview process.