Principal Validation Engineer

Perform valuation of manufacturing processes, equipment, and systems to ensure compliance with various safety guidelines. Prepare validation protocols for new or modified manufacturing processes. Analyze and document validation studies to determine whether processes meet validation criteria. Coordinate protocol execution activities for equipment. Coordinate validation activities with plan support groups including Operations, Maintenance, Engineering, and Quality.

What You Will Do

Generate final summary report. Plan on time delivery of project engineering schedules and plans. Recommend process improvement activities while ensuring compliance with site, corporate, and regulatory standards.

Why It Might Be a Fit

Must have three (3) years of experience with/in: Working within GMPs or FDA regulated industries such as Medical Device or Pharmaceuticals; Performing process validation using CSV, IQ, OQ, or PQ protocols; Developing validation test cases, process flow diagrams, or standard operational procedures; Applying knowledge of manufacturing technologies such as Lean Manufacturing or Six sigma; Creating and updating manufacturing procedures; Using MS Project and Share Point to manage validation project execution; and Coordinating validation activities with various support groups for high-speed automated equipment, manufacturing, printing, and inspection of medical devices.

Requirements

• Bachelor’s degree, or foreign equivalent degree, in Industrial Engineering, Biomedical Engineering, Manufacturing Engineering or a related field
• Three (3) years of related work experience
• Three (3) years of experience with/in: Working within GMPs or FDA regulated industries such as Medical Device or Pharmaceuticals; Performing process validation using CSV, IQ, OQ, or PQ protocols; Developing validation test cases, process flow diagrams, or standard operational procedures; Applying knowledge of manufacturing technologies such as Lean Manufacturing or Six sigma; Creating and updating manufacturing procedures; Using MS Project and Share Point to manage validation project execution; and Coordinating validation activities with various support groups for high-speed automated equipment, manufacturing, printing, and inspection of medical devices

Benefits

• 40 hours/week, Mon-Fri, 8:30 a.m. - 5:30 p.m.
• Telecommuting permitted up to 2 days per week
• Healthcare
• PTO
• Retirement
• Learning budget
• Parental leave
• Wellness
• Visa/relocation
• Remote flexibility
• Stipends
• Bonus/commission
• Paid holidays