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Computer System Validation Csv Pharmaceutical Jobs in Georgia

Pinnaql

Validation Engineer

Atlanta, GA · On-site

... Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following ... Computer System Validation (CSV) as well as hands-on experience with systems and controls ...

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Atlanta, GA · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Cypress HCM

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 ...

UCB

Technical Lead CRM

Atlanta, GA · On-site

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 ...

System One

Pharmacovigilance Systems Analyst

Athens, GA · On-site

$30 - $34/hr

Execute SQL queries and reports, support computerized system validation activities, and assist with ... Experience supporting GxP-regulated computerized systems within a pharmaceutical, biotechnology, or ...

New

Wellstar Health System

$51.25 - $57.25/hr

General Pharmacy Practice Preparing IV Admixtures, compounding, and repackaging a wide variety of pharmaceuticals Entering and verifying orders into the pharmacy computer system, and proper ...

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Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Georgia?

For Computer System Validation Csv Pharmaceutical jobs in Georgia, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Georgia look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Georgia are:

What cities in Georgia are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Georgia with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you

Validation Engineer

Validation & Engineering Group, Inc

Atlanta, GA • On-site

Full-time

Re-posted 9 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.