Senior Validation Engineer: GMP, CSV & Equipment Startup

Veg Group; Beloit (OH); On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a talented Validation Engineer to drive the full validation lifecycle in GMP settings. You will develop URS, lead FAT/SAT/CSV, and oversee equipment integration from design through startup and qualification, ensuring safety, regulatory, and quality standards are met.

The role includes coordinating with procurement and vendors, preparing engineering documentation, and driving process improvements to reduce costs and improve manufacturability.

Qualifications

• Bachelor's degree in Engineering or Science.
• 4+ years of engineering experience in pharmaceutical and/or medical device industries.
• Experience across the full validation lifecycle (URS, FAT, SAT, CSV).
• Proven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.
• Experience leading capital projects within GMP-regulated manufacturing environments.
• Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.
• Ability to work independently and lead solutions under general direction.
• Strong organization and communication skills.

Responsibilities

• Develop User Requirement Specifications (URS).
• Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.
• Drive process design for new equipment and ensure product design requirements are met.
• Execute commissioning and qualification activities for new and existing equipment.
• Provide technical oversight to ensure equipment meets safety, regulatory, and operational standards.
• Manage suppliers and external vendors on capital projects, controlling scope, cost, and lead time.
• Collaborate with Procurement and Legal on vendor contracts.
• Create and maintain engineering documentation (URS, assembly instructions, bill of process, etc.).
• Optimize equipment design for manufacturability, cost reduction, maintainability, and efficiency.
• Lead design reviews, risk assessments, and FMEA to ensure reliability and performance.
• Ensure compliance with all safety regulations and quality policies, procedures, and GMP standards.
• Apply statistical analysis and SPC systems to support data-driven decision-making.
• Manage multiple priorities and maintain equipment qualification schedules.

Skills

Communication skills

Organizational skills

Independence

GMP familiarity

ISO standards familiarity

Education

Bachelor's degree in Engineering or Science

Job description

Validation & Engineering Group, Inc. seeks a talented Validation Engineer to drive the full validation lifecycle in GMP settings. You will develop URS, lead FAT/SAT/CSV, and oversee equipment integration from design through startup and qualification, ensuring safety, regulatory, and quality standards are met.

The role includes coordinating with procurement and vendors, preparing engineering documentation, and driving process improvements to reduce costs and improve manufacturability.