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Director Computer System Validation Csv Jobs in Georgia

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 ...

Senior System Validation Engineer

Johns Creek, GA · Hybrid

$96K - $132K/yr

S. in Computer Engineering, Electrical Engineering, or related field. * 5+ years of experience in system validation, memory interfaces, or related semiconductor work. * Must have expertise in high ...

The role focuses on ensuring systems, equipment, automation platforms, and validation documents meet GMP, quality, safety, and regulatory standards . Key Responsibilities * Support CSV and ...

Experience with Computerized System Validation (CSV), SDLC processes, and 21 CFR Part 11 compliance. The reasonably anticipated salary range for this position is $125,600-$164,900 per year. The ...

New

Experience with Computerized System Validation (CSV), SDLC processes, and 21 CFR Part 11 compliance. The reasonably anticipated salary range for this position is $125,600-$164,900 per year. The ...

New

The Technical Director Validation Engineer is a Full-Time position and the candidate will work in ... Provide inputs to FPGA, system, and PCB design requirements. * Support Applications Team in ...

... Director Validation Engineer to join our Memory Interface Chip business unit. Candidates will be ... Provide inputs to FPGA, system, and PCB design requirements. * Support Applications Team in ...

... Director Validation Engineer to join our Memory Interface Chip business unit. Candidates will be ... Provide inputs to FPGA, system, and PCB design requirements. * Support Applications Team in ...

Bachelor's degree in engineering or computer science is strongly preferred * 4+ years' experience ... GAMP5, CSV/CSA, data integrity (ALCOA+), and computerized system validation/assurance.

New

Bachelor's degree in engineering or computer science is strongly preferred * 4+ years' experience ... GAMP5, CSV/CSA, data integrity (ALCOA+), and computerized system validation/assurance.

New

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Full-time

Re-posted 5 days ago


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.
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.