Senior Validation Project Manager – Life Sciences

BW Design Group; Indianapolis (IN); On-site; USD 110,000 - 165,000; Full time

Job summary

BW Design Group is seeking a Validation Project Manager to lead teams in validation/quality service for life sciences projects. You will interface with clients, develop project scope, estimates, and proposals, and guide commissioning, qualification, and validation activities.

We value leadership, strong communication, and a track record of delivering compliant solutions under cGMP and FDA methods. Occasional travel to client sites will be required as projects demand.

Qualifications

• Bachelor's degree in engineering or a related technical field.
• Minimum 7 years in validation/quality service and project management in life sciences or FDA-regulated projects.
• Experience with EPCMV, Quality by Design, data integrity, 21 CFR Part 11.
• Ability to travel as necessary for project requirements.

Responsibilities

• Lead validation teams and interface with clients on projects.
• Develop scope statements, estimates, and proposals.
• Manage multiple projects simultaneously from planning to delivery.
• Provide Subject Matter Expert guidance in commissioning, qualification, and validation.
• Mentor teams and coordinate external consultants.

Skills

Project Management

Validation & QA

FDA Validation Methods

cGMP

Risk Assessment (FMEA/HAZOP)

Leadership

Client Communication

Documentation & GMP Records

Process Equipment Validation

Education

BS Degree in Engineering or related technical degree

Job description

BW Design Group is seeking a Validation Project Manager to lead teams in validation/quality service for life sciences projects. You will interface with clients, develop project scope, estimates, and proposals, and guide commissioning, qualification, and validation activities.

We value leadership, strong communication, and a track record of delivering compliant solutions under cGMP and FDA methods. Occasional travel to client sites will be required as projects demand.