Validation Engineer

Pinnaql, Inc.

Atlanta (GA)

Hybrid

USD 90,000 - 120,000

Full time

7 days ago
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Job summary

Validation & Engineering Group, Inc. in the Atlanta area is seeking a Validation Engineer for future opportunities. The role covers the full validation lifecycle—from URS development through FAT, SAT, and CSV—assessing equipment integration, startup, and qualification.

This is a future postings scenario with on-site or hybrid expectations. The ideal candidate will lead design reviews, risk assessments, and supplier management for capital projects, ensuring safety and regulatory compliance.

Qualifications

  • URS development and validation lifecycle experience.
  • Leadership of validation lifecycle activities including FAT, SAT, CSV.
  • Experience with GMP, ISO standards, and FDA-regulated environments.

Responsibilities

  • Develop URS.
  • Lead validation lifecycle activities: FAT, SAT, CSV, equipment integration, startup.
  • Drive process design for new equipment and ensure design requirements are met.
  • Execute commissioning and qualification for new and existing equipment.
  • Provide technical oversight for 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 for reliability and performance.
  • Ensure compliance with safety regulations and GMP standards.
  • Apply statistical analysis and SPC to support data-driven decisions.
  • Manage multiple priorities and equipment qualification schedules.

Skills

URS development
FAT/SAT/CSV
GMP compliance
Equipment qualification
Regulatory standards
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.

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.

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