Validation Engineer

Validation & Engineering Group, Inc.; Atlanta (GA); On-site; USD 80,000 - 100,000; Full time

Job summary

Pinnaql in Atlanta, Georgia is seeking a Validation Engineer with deep technical expertise across the full validation lifecycle. The successful candidate will lead project implementation from equipment design and installation to startup, commissioning, and qualification. A Bachelor's degree in Engineering or Science and a minimum of 4 years of experience in the pharmaceutical or medical device industries are required. The position also calls for strong organization and communication skills along with experience in GMP-regulated environments.

Qualifications

• Minimum 4 years of engineering experience in pharmaceutical and/or medical device industries.
• Demonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).
• Strong experience executing capital projects within GMP-regulated manufacturing environments.

Responsibilities

• Develop User Requirement Specifications (URS).
• Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.
• Provide technical oversight to ensure equipment meets safety, regulatory, and operational standards.

Skills

Deep technical expertise in validation lifecycle

Experience with URS development

Hands-on systems and controls integration

Statistical analysis and SPC

Strong organization and communication skills

Education

Bachelor's degree in Engineering or Science

Job description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier that provides solutions for the pharmaceutical, biotechnology, chemical, food, and medical devices industries in laboratory, compliance, computer, engineering, project management, validation, and other services.

Job Title

Validation Engineer

Role 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.

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.