CQV Validation Project Lead (Life Sciences)

Barry-Wehmiller; Indianapolis (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Design Group in the United States seeks a Validation Project Manager to lead CQV validation work for capital projects in life sciences. You will coordinate teams, develop validation plans, and ensure compliance with cGMP and FDA methods while partnering with clients to deliver high-quality solutions.

You will mentor staff, contribute to business development in the life sciences sector, and travel as needed for project start-up and client meetings. A BS in Engineering or related field is required.

Qualifications

• Minimum of 7 years in validation/quality service and project management for life sciences or FDA-regulated projects.
• Experience with project management, good documentation practices, and engineering document reading.
• Familiarity with EPCMV, risk-based validation approaches and data integrity expectations.

Responsibilities

• Coordinate validation activities across multiple functional areas for capital projects.
• Lead the validation of utility, facility and process equipment within life sciences projects.
• Develop scope statements, estimates and proposals and manage project milestones and costs.
• Mentor teams, engage with clients, and expand regional life sciences engagements.
• Deliver sound, compliant validation approaches and lead protocol execution when needed.
• Travel as required for project installation, start-up activities, and client meetings.

Skills

Project management

Validation

Quality by Design

FDA validation methods

cGMP

Risk assessment (FMEA/HAZOP)

Reading engineering docs

Client liaison

Education

BS Degree in Engineering or related technical degree

Tools

GAMP methodologies

21 CFR Part 11

Job description

Design Group in the United States seeks a Validation Project Manager to lead CQV validation work for capital projects in life sciences. You will coordinate teams, develop validation plans, and ensure compliance with cGMP and FDA methods while partnering with clients to deliver high-quality solutions.

You will mentor staff, contribute to business development in the life sciences sector, and travel as needed for project start-up and client meetings. A BS in Engineering or related field is required.