Validation Engineer
Validation & Engineering Group, Inc
Job Description
Job Description
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.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- 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.
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