Senior Validation Project Lead – Life Sciences & GMP

Barry-Wehmiller Companies Inc.; Santa Ana (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Barry-Wehmiller Companies Inc. seeks a Sr. Validation Project Manager for our Design Group in Santa Ana, CA. You will lead validation teams, interface with clients, and drive regulatory compliance across utility, facility and process systems.

You will bring 7+ years in validation and project management within FDA-regulated environments, with strong leadership, documentation, and risk-management skills. Travel to client sites is expected as needed.

Qualifications

• Minimum of 7 years’ experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
• This position requires experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
• Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
• Project Management experience in managing scope, cost, schedule, quality, and risk is required.

Responsibilities

• Sr. Project Manager will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
• Lead business development efforts in the region related to engaging with new clients in the life sciences sector and expanding engagements with existing clients.
• Develop project scope statements, estimates and proposals; manage multiple projects simultaneously.

Skills

Project management

Leadership

Verbal communication

Technical writing

Risk assessment

cGMP

FDA validation

Quality by Design

Reading engineering docs

Mentorship

Travel readiness

Education

BS in Engineering

Tools

Microsoft Word

Excel

Job description

Barry-Wehmiller Companies Inc. seeks a Sr. Validation Project Manager for our Design Group in Santa Ana, CA. You will lead validation teams, interface with clients, and drive regulatory compliance across utility, facility and process systems.

You will bring 7+ years in validation and project management within FDA-regulated environments, with strong leadership, documentation, and risk-management skills. Travel to client sites is expected as needed.