Lead Validation Engineer — cGMP & CSV Expert

BW Design Group; Columbus (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

BW Design Group is seeking a Validation Engineer to lead validation activities across equipment, utilities, processes, and computerized systems in a regulated environment. You will author protocols, coordinate qualification activities, and provide SME guidance to cross-functional teams.

The role requires strong technical writing, cGMP knowledge, and experience supporting regulatory inspections. On-site work at our Columbus, OH location with potential for project-based travel supports capital and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required.
• Master's degree (MS/MSc) preferred.

Responsibilities

• Author, review, and approve validation protocols and reports.
• Establish and maintain validation master plans and lifecycle documentation.
• Execute IQ/OQ/PQ protocols for equipment, utilities, and systems.
• Review documentation for cGMP, ALCOA+ data integrity.

Skills

Process mapping

Quality management

Equipment qualification

Cleaning validation

CSV validation

Process validation

Environmental monitoring

Technical writing

Education

Bachelor's degree in Eng/Life Sciences

Master's degree preferred

Job description

BW Design Group is seeking a Validation Engineer to lead validation activities across equipment, utilities, processes, and computerized systems in a regulated environment. You will author protocols, coordinate qualification activities, and provide SME guidance to cross-functional teams.

The role requires strong technical writing, cGMP knowledge, and experience supporting regulatory inspections. On-site work at our Columbus, OH location with potential for project-based travel supports capital and