Validation Engineer at Validation & Engineering Group, Inc. in Greenville, NC

Job description

• We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
• Validation Engineer
• The role demands deep technical expertise across the full validation lifecycle — including URS development, FAT/SAT execution, and Computer System Validation (CSV) — as well as hands-on experience with systems and controls integration. The candidate will drive end-to-end project implementation: from equipment design and installation through startup, commissioning, and qualification.

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.

Requirements

• Bachelor's degree in Engineering or Science.
• Minimum 4 years of engineering experience in pharmaceutical and/or medical device industries.
• Demonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).
• Proven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.
• Strong experience executing 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

Skills

Required

• Computer System Validation (CSV)
• Statistical analysis and SPC systems
• FMEA