Validation Engineer

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:

• Bachelors 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 youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its 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.

Required Experience:

IC