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Computer System Validation Manager Jobs in Missouri

kindeva

Validation Engineer I

Saint Louis, MO · On-site

... systems, incubators, freezers, refrigerators and assembly equipment). * Issue data, memos and ... Perform special projects as assigned by department manager. * Adhere to all company and GMP ...

kindeva

Validation Engineer I

Saint Louis, MO

... systems, incubators, freezers, refrigerators and assembly equipment). * Issue data, memos and ... Perform special projects as assigned by department manager. * Adhere to all company and GMP ...

kindeva

Validation Engineer I

Saint Louis, MO

... systems, incubators, freezers, refrigerators and assembly equipment). * Issue data, memos and ... Perform special projects as assigned by department manager. * Adhere to all company and GMP ...

kindeva

Validation Engineer I

Saint Louis, MO

... systems, incubators, freezers, refrigerators and assembly equipment). * Issue data, memos and ... Perform special projects as assigned by department manager. * Adhere to all company and GMP ...

Endo International

Lead Validation Eng

Saint Louis, MO · On-site

... computer system software and other validation activities as needed to support the Specialty ... Management of data integrity gap assessments and remediation * Performs equipment/system/process ...

Lancesoft

Validation Associate

Kansas City, MO · On-site

$23 - $26/hr

Participate in any tasks associated with system implementation or upgrades as required. * Lead ... Bachelor s Degree in Life Sciences, Physical Science, Computer Science or Engineering field with ...

Lancesoft

Validation Associate

Kansas City, MO · On-site

$23 - $26/hr

Participate in any tasks associated with system implementation or upgrades as required. * Lead ... Bachelor s Degree in Life Sciences, Physical Science, Computer Science or Engineering field with ...

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Computer System Validation Manager information

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$44.6K

$98.9K

$150.6K

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 Missouri is $98,880.00, according to ZipRecruiter salary data. Most workers in this role earn between $69,900.00 and $123,800.00 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 Missouri? The most popular types of Computer System Validation jobs in Missouri are:
What are popular job titles related to Computer System Validation Manager jobs in Missouri? For Computer System Validation Manager jobs in Missouri, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Missouri look for? The top searched job categories for Computer System Validation Manager jobs in Missouri are:
What cities in Missouri are hiring for Computer System Validation Manager jobs? Cities in Missouri 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 Missouri as of May 2026, with employment types broken down into 52% Full Time, 44% Part Time, and 4% Contract. Highlights an 84% Physical, and 16% Remote job distribution, with an average salary of $98,880 per year, or $47.5 per hour.

Product Process Validation Manager

kindeva

Bridgeton, MO

Other

Posted yesterday

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.

The Impact You Will Make

The is an exciting opportunity as Product Process Validation Manager is a key member of the Manufacturing Science & Technology (MS&T) organization, responsible for leading process validation strategy and execution across the product lifecycle. This role oversees the design, authorship, and facilitation of technology transfer activities, Process Performance Qualification (PPQ) protocols and reports, and supporting ongoing Continued Process Verification (CPV). The manager partners closely with Process Development, Quality, Manufacturing, and Regulatory Affairs to ensure robust, compliant, and efficient validation programs. This position reports directly to the Director of MS&T.

Role Responsibilities

Process Validation & PPQ

  • Lead the development, authorship, and execution of process validation strategies in alignment with regulatory expectations (e.g., FDA, EMA, ICH Q8–Q11).
  • Write, review, and approve PPQ protocols, sampling plans, risk assessments, and final reports.
  • Facilitate cross-functional PPQ readiness, including coordinating activities with Manufacturing, Quality Control, and Quality Assurance.
  • Ensure validation deliverables meet internal standards and external regulatory requirements.

Technology Transfer

  • Serve as the MS&T lead for technology transfer of new products, processes, or scale-up activities into manufacturing.
  • Develop and maintain tech transfer plans, process descriptions, and knowledge transfer documentation.
  • Drive process fit-gap assessments, risk analyses, and mitigation strategies.
  • Support equipment and facility readiness, including URS development and process capability assessments.

Continued Process Verification (CPV)

  • Partner with data analytics and quality teams to monitor process performance, identify trends, and drive data-based decision-making.
  • Lead investigations and corrective actions related to process performance deviations or CPV signals.

Cross-Functional Leadership

  • Collaborate with Process Development to translate laboratory-scale processes into robust, scalable manufacturing processes.
  • Support Regulatory Affairs with process validation content for submissions, responses to regulatory queries, and inspections.
  • Provide technical leadership during audits and regulatory inspections.
  • Mentor and guide junior MS&T staff in validation and tech transfer best practices.

Documentation & Compliance

  • Ensure all validation and tech transfer documentation is accurate, complete, and audit-ready.
  • Maintain strong alignment with internal quality systems, change control, and document management processes.
  • Champion continuous improvement initiatives to enhance validation efficiency and process robustness.

Basic Qualifications

  • Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, or related field.
  • 7+ years of experience in biopharmaceutical or pharmaceutical manufacturing, MS&T, process validation, or related technical functions.
  • Demonstrated expertise in PPQ, CPV, and technology transfer.
  • Strong understanding of cGMP regulations and global validation guidelines.
  • Excellent technical writing, communication, and project management skills.

Preferred

  • Experience with biologics, cell therapy, gene therapy, or aseptic manufacturing.
  • Familiarity with statistical tools (e.g., JMP, Minitab) for process analysis.
  • Prior leadership or team management experience.
  • Experience supporting regulatory inspections.

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