Senior Validation Engineer - GMP Compliance Lead

cGMP Consulting Inc.; Cincinnati (OH); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting Inc. seeks an experienced senior leader to manage multiple validation and qualification projects across equipment, utilities, facilities, systems, and processes in a GMP environment.

The role offers significant autonomy and cross-functional leadership to influence operations in a fast-paced, regulated manufacturing setting. The ideal candidate brings deep cGMP experience, FDA regulatory knowledge, and a track record of delivering thorough protocols, reports, and CAPA-driven

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 5+ years in GMP manufacturing including drafting SOPs, protocols, and reports; familiar with FDA.
• Expertise in cleaning validation, aseptic filling/formulation equipment, and packaging qualification.
• Hands-on experience with temperature validation equipment (e.g., Temptales, Kaye).
• Strong technical writing, critical thinking, and organizational skills.

Responsibilities

• Lead development and authorship of specifications and documentation (URS, RA, FS) for new processes, equipment, and systems.
• Oversee engineering projects from concept to execution with technical leadership.
• Direct equipment commissioning activities with cross-functional teams.
• Design and review validation/qualification studies for utilities, equipment, and manufacturing processes.
• Manage concurrent qualification initiatives and communicate with stakeholders for alignment.
• Lead cross-functional meetings and ensure timely follow-up on action items.
• Contribute to capital project forecasting and long-term resource planning.
• Provide oversight for analytical instrumentation and environmental qualifications.

Skills

GMP manufacturing

Technical writing

Project leadership

Communication skills

Interpersonal skills

Analytical thinking

Regulatory knowledge

Education

Bachelor's degree in Engineering/Science

Tools

Temptales

Kaye

eDMS

QMS

Microsoft Office

Job description

cGMP Consulting Inc. seeks an experienced senior leader to manage multiple validation and qualification projects across equipment, utilities, facilities, systems, and processes in a GMP environment.

The role offers significant autonomy and cross-functional leadership to influence operations in a fast-paced, regulated manufacturing setting. The ideal candidate brings deep cGMP experience, FDA regulatory knowledge, and a track record of delivering thorough protocols, reports, and CAPA-driven