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Computer System Validation Manager Jobs in Kentucky

kindeva

Sr. Validation Engineer

Lexington, KY

Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment. Preferred Qualifications: * Familiarity with validation of automated systems and ...

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment. Preferred Qualifications: * Familiarity with validation of automated systems and ...

kindeva

Sr. Validation Engineer

Lexington, KY · On-site

Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment. Preferred Qualifications: * Familiarity with validation of automated systems and ...

kindeva

Sr. Validation Engineer

Lexington, KY

Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment. Preferred Qualifications: * Familiarity with validation of automated systems and ...

Catalent, Inc.

Validation Specialist

Winchester, KY · On-site

Draft protocols and reports for Computerized Systems Validation, and/or Automated Production ... Obtaining approval signatures from the Catalent management and as required from customers.

kindeva

Manager, Validation Engineer

Lexington, KY · On-site

As a Validation Engineer Manager, you will lead and direct validation strategy across manufacturing processes, equipment, utilities, and computerized systems within a regulated pharmaceutical ...

Stefanini Group

IT Support Analyst II

Owensboro, KY

... Management, Open+, Logistic supply chain) * Actively participate in the implementation of new ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini Group

IT Support Analyst II

Owensboro, KY

... Management, Open+, Logistic supply chain) * Actively participate in the implementation of new ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini Group

IT Support Analyst II

Owensboro, KY

... Management, Open+, Logistic supply chain) * Actively participate in the implementation of new ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

Stefanini Group

IT Support Analyst II

Owensboro, KY · On-site

$32 - $35/hr

... Management, Open+, Logistic supply chain) * Actively participate in the implementation of new ... Strong background in GMP, GAMP, and Computer System Validation (CSV) * Hands-on experience ...

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Computer System Validation Manager information

See Kentucky salary details

$41.3K

$91.6K

$139.4K

How much do computer system validation manager jobs pay per year?

As of Jun 1, 2026, the average yearly pay for computer system validation manager in Kentucky is $91,556.00, according to ZipRecruiter salary data. Most workers in this role earn between $64,700.00 and $114,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Computer System Validation Manager, and why are they important?

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a Computer System Validation Manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What does a Computer System Validation Manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are the most commonly searched types of Computer System Validation jobs in Kentucky? The most popular types of Computer System Validation jobs in Kentucky are:
What are popular job titles related to Computer System Validation Manager jobs in Kentucky? For Computer System Validation Manager jobs in Kentucky, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Kentucky look for? The top searched job categories for Computer System Validation Manager jobs in Kentucky are:
What cities in Kentucky are hiring for Computer System Validation Manager jobs? Cities in Kentucky with the most Computer System Validation Manager job openings:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Kentucky as of May 2026, with employment types broken down into 24% Full Time, 68% Part Time, and 8% Contract. Highlights an 85% Physical, and 15% Remote job distribution, with an average salary of $91,556 per year, or $44 per hour.

Sr. Validation Engineer

kindeva

Lexington, KY

Other

Posted 15 days ago

Kindeva rating

6.8

Company rating: 6.8 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activities—including equipment, utilities, facilities, and process validations—to ensure our operations remain compliant and inspection-ready. Your expertise in cGMP, risk-based validation, and technical writing will directly impact the safety, efficacy, and consistency of the drug products we deliver. This is a highly visible, hands-on role ideal for a detail-oriented professional passionate about quality and continuous improvement in a dynamic, fast-paced environment

Responsibilities:

Validation Strategy & Execution

  • Develop, execute, and maintain validation protocols and reports (IQ, OQ, PQ) for equipment, utilities, and manufacturing processes.
  • Support commissioning and qualification (C&Q) activities for new equipment and facilities, ensuring compliance with FDA, EU, and global regulatory expectations.
  • Author and review validation lifecycle documentation, including plans, protocols, deviations, and final reports.
  • Partner with Engineering, Manufacturing, Quality, and Regulatory Affairs to ensure effective cross-functional validation planning and execution.
  • Perform periodic reviews and revalidation activities in accordance with lifecycle requirements.

Compliance & Risk Management

  • Lead risk assessments (FMEA, gap assessments) to determine validation strategy and appropriate testing requirements.
  • Provide validation input during change control, deviation investigations, and CAPA execution.
  • Ensure data integrity and good documentation practices in all validation records.
  • Act as subject matter expert (SME) during internal and external audits and inspections.

Continuous Improvement

  • Evaluate validation program effectiveness and recommend process improvements to enhance compliance, efficiency, and scalability.
  • Stay current with industry best practices and evolving regulatory guidance to ensure validation activities remain aligned with expectations.

Qualifications:

  • Bachelor’s degree in engineering, life sciences, or a related technical field.
  • 5 or more years of validation experience; or 3 years with a Master’s degree 
    in a regulated pharmaceutical, biotech, or medical device environment.
  • Demonstrated knowledge of FDA, EU, and ICH regulatory requirements including 21 CFR Part 11 and Annex 15.
  • Experience in developing and executing validation documentation (IQ/OQ/PQ, protocols, reports).
  • Strong organizational, communication, and technical writing skills.
  • Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment.

Preferred Qualifications:

  • Familiarity with validation of automated systems and computerized system validation (CSV).
  • Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation.
  • Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva).
  • Lean Six Sigma or other continuous improvement training/certifications.

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