Validation Engineer

Pinnaql, Inc.; Holly Springs (NC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a skilled Validation Engineer to lead URS, FAT, SAT and CSV across GMP projects, from equipment design to startup.

You will ensure compliance with GMP, ISO, Lean, and FDA-regulated environments, manage vendors, and deliver documented validation for capital projects.

Qualifications

• 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.

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

Independent work

Leadership

Education

Bachelor's degree in Engineering or Science

Job description

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

This posting is for future opportunities which could be onsite or hybrid. While this is not tied to an immediate opening, we actively review submissions and connect with candidates as project needs arise.

Validation Engineer

Description:

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.

Key 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.

Qualifications:

• 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

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.