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Computer System Validation Csv Pharmaceutical Jobs in Georgia

Clarkston Consulting

LIMS Consultant

Atlanta, GA · On-site +1

... CSV teams, and IT to gather requirements, design technical solutions, and support system validation ... Experience working in regulated environments such as pharmaceuticals, biotechnology, or food safety

Janus Rx

PRN Pharmacist, Janus RX Augusta, GA

Augusta, GA · On-site

$54.75 - $65.75/hr

... Pharmaceutical Education; Baccalaureate or PharmD degree required. • Current and valid ... computer systems. 8. Physical Demands: • Reasonable accommodations may be made to enable ...

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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.

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

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

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Computer System Validation Csv Pharmaceutical jobs near you

LIMS Consultant

Clarkston Consulting

Atlanta, GA • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 10 hours ago

Key responsibilities

  • Configure LIMS modules to support workflows such as assay development, sample management, and analytical testing processes

  • Design, configure, and validate assay workflows in compliance with scientific requirements and regulated environments

  • Develop and maintain scripts for workflow automation, business rules, calculations, instrument integration, and data transformation

Job description

This job is posted in multiple locations. When not at a client site, consultants work from their home office. Relocation is not required.

Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a LIMS Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the life sciences, consumer products, and retail industries.

Together, we can find the answers to our clients' most challenging business problems through a combination of our industry expertise, business process knowledge, and consulting excellence.

What You'll Do

As a LIMS Consultant at Clarkston you will:

  • Configure LIMS modules to support workflows, including assay development, plate results, sample management, stability, and analytical testing processes
  • Design, configure, and validate assay workflows within, ensuring alignment with scientific requirements and regulated (GxP) environments
  • Develop and maintain scripts for workflow automation, business rules, calculations, instrument integration, and data transformation within LIMS
  • Develop project documentation and conduct demos of configuration to clients
  • Collaborate with scientists, QA/CSV teams, and IT to gather requirements, design technical solutions, and support system validation activities (URS, FRS, DS, IQ/OQ/PQ)
  • Ensure configurations comply with 21 CFR Part 11 and other validation procedure
  • Collaborate with a team of LIMS consultants working across various sites for LIMS deployment

How You'll Grow
Beyond your day-to-day responsibilities, throughout your career at Clarkston you will:

  • Receive the support and mentorship of your Clarkston colleagues and leaders
  • Expand your existing skillset with internal and external professional development opportunities

Requirements

What We're Looking For:

  • Minimum of 2 years of hands-on experience working with LabWare or LabVantage LIMS
  • Experience configuring and customizing LabWare or LabVantage LIMS to support laboratory workflows
  • Proven ability to design, configure, and validate assay workflows
  • Experience developing and maintaining scripts for workflow automation, business rules, calculations, instrument integrations, and data transformations
  • Solid understanding of laboratory operations and end-to-end lab processes
  • Proficient in developing comprehensive project documentation and delivering configuration demonstrations to clients
  • Excellent attention to detail with strong analytical and problem-solving skills
  • Effective communication and collaboration skills, with the ability to work across cross-functional teams
  • Experience working in regulated environments such as pharmaceuticals, biotechnology, or food safety
  • Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements
  • 4-year degree in Life Sciences, Information Technology, or a related discipline

Travel Requirement
Travel is an integral part of this role and is estimated to average 30-50%. This may vary based upon client and project needs. When not traveling, consultants work from their home office. Relocation is not required.

More About Clarkston

Founded in 1991, Clarkston Consulting delivers technology and management solutions to market leaders in the life sciences, consumer products, and retail industries. At Clarkston, we cultivate success - for our clients, for our people, and for our firm. We utilize a team approach leveraging our collective expertise and industry knowledge to solve our clients' business challenges.

AI Statement

Clarkston values thoughtful and responsible AI use for resume writing, interview preparation, and research. However, real-time use of AI to generate or script answers during interviews - including video or live conversations - is strictly prohibited and will lead to disqualification. We seek candidates who show authenticity, good judgment, and genuine engagement throughout the process.

Benefits

Our benefits include:

  • Comprehensive Health and Wellness Benefits (Medical, Dental, Vision, and more)
  • 401k with company contributions
  • Paid vacation, personal days, holidays, and sick leave
  • Paid Parental Leave and Family Building Benefits (Adoption, Surrogacy, and Infertility Support)
  • Life and Disability Insurance
  • Training and Professional Development investments, Tuition Assistance, and more

We strive to ensure that every candidate has an equitable and accessible experience. If you are selected to move forward in the interview process, we will share information about how to request any accommodations. You may also request support at any point during the hiring process.

Visit Careers at Clarkston to learn more about our culture, benefits, and opportunities.

Clarkston Consulting is an equal opportunity employer. We are committed to ensuring our firm is rich in diverse skills, competencies, strengths, personalities, and culture. We foster an inclusive environment that embraces the unique contributions of our people to further our purpose. Please visit Diversity @ Clarkston to learn more about our diversity initiatives.

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