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Computer System Validation Manager Jobs in Illinois

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

This role supports system validation strategy, audit readiness, CAPA management, and risk-based ... Bachelor's degree in business, information systems, computer science, engineering, or equivalent ...

Position Overview We are seeking experienced IT Validation Leads to drive GxP computer system ... to manage validation deliverables and drive testing execution to completion * Identify compliance ...

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

Senior System Validation Engineer DUTIES: Validating complex embedded software interactions ... Bachelor's degree (or foreign equivalent) in Computer Science, Computer Engineering or related ...

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Showing results 1-20

Computer System Validation Manager information

See Illinois salary details

$46K

$102.2K

$155.5K

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

As of Jul 27, 2026, the average yearly pay for computer system validation manager in Illinois is $102,150.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,200.00 and $127,900.00 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 Illinois? The most popular types of Computer System Validation jobs in Illinois are:
What are popular job titles related to Computer System Validation Manager jobs in Illinois? For Computer System Validation Manager jobs in Illinois, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Manager jobs in Illinois look for? The top searched job categories for Computer System Validation Manager jobs in Illinois are:
What cities in Illinois are hiring for Computer System Validation Manager jobs? Cities in Illinois with the most Computer System Validation Manager job openings:
Infographic showing various Computer System Validation Manager job openings in Illinois as of July 2026, with employment types broken down into 57% Full Time, and 43% Contract. Highlights an 100% In-person job distribution, with an average salary of $102,150 per year, or $49.1 per hour.
Manager, Facilities & Software Validations

Manager, Facilities & Software Validations

PCI Pharma Services

Rockford, IL • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 11 days ago


PCI Pharma Services rating

6.7

Company rating: 6.7 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

439th of 535 rated manufacturers


Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
The Facilities and Software Validations Manager is responsible for coordinating and managing all validation efforts related to Facility/Utility and Computer Equipment at multiple facilities. The Validations Manager is responsible for designing, maintaining and continually improving the validation system. The Validations Manager is responsible for implementation and ongoing improvements of the validation policies, protocols and testing. Provide technical expertise and guidance to customers, the Validations department as well as working with the range of internal departments. Coordinate with other departments to communicate validations and provide resources to implement protocol executions. The Facilities and Software Validations Manager assures customer requirements are accurately incorporated into PCI systems and assures validation protocols adhere to cGMP requirements.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
  • Oversees and manages Validations Supervisor(s), engineers, and, as required, other Validations personnel Manage, identify, hire, and develop staff.
  • Create and maintain employee and organizational development.
  • Oversee proper training, goal setting and effective organizing and assigning of work.
  • Reviews and approves validation and change control documentation, including protocols, summary reports, etc., for validation activities, process parameters, and validation work practices.
  • Manage and develop facility, utility, and computer validations program that is in compliance with regulatory and customer expectations, which includes developing and maintaining Validation Master Plan and policy and work practices. Design, maintain and continually improving the validation system in line with current national and international standards.
  • Assist with validation harmonization among sites across the PCI Pharma Services organization.
  • Provide Validation technical expertise and guidance to the groups within the organization and customers on validation policies and procedures and the implementation of those within the Operations and Quality Assurance (QA) functional areas.
  • Develops and administers budgets, schedules and performance requirements and evaluations.
  • Plan, execute, and oversee validation of facilities, cleanrooms, and utilities (HVAC, compressed air, water systems, gases).
  • Develop and approve validation documentation including URS, risk assessments, IQ, OQ, PQ, and validation summary reports.
  • Ensure facility changes are evaluated through change control and revalidation activities as required.
  • Support environmental monitoring programs and facility qualification strategies.
  • Lead CSV activities in accordance with GAMP 5, FDA, and ISO requirements.
  • Define validation strategies based on system impact, intended use, and risk.
  • Review and approve system lifecycle documentation (URS, FS, DS, risk assessments, test scripts, traceability matrices).
  • Ensure data integrity principles (ALCOA+) are applied across computerized systems.
  • Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various product quality systems such as Change Control and CAPA.
  • Participates, present and provide rationale for the validation program during periodic audits and regulatory inspection and customer visits/conference calls as required.
  • This position may require overtime and/or weekend work. Performs other duties as assigned by Director.the

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
  • Minimum of 6-8 years of experience in facilities, utilities, and computer system validation in a regulated industry (medical devices, pharmaceutical, or biotechnology).
  • Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
  • Prior experience supervising or leading validation personnel preferred.
  • Strong understanding of validation lifecycle activities (URS, risk assessments, IQ, OQ, PQ, and validation reports).
  • In-depth knowledge of Computer System Validation (CSV) and GAMP 5 methodology.
  • Working knowledge of FDA regulations (21 CFR Parts 820, 210/211, and 11).
  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
  • High Standard of Report Writing

Preferred:
  • Ability to effectively present information to various people as the job requires.
  • Ability to identify and resolve problems in a timely manner.
  • Ability to display original thinking and creativity.
  • Ability to show success in managing employees.
  • Ability to demonstrate attention to detail.
  • Ability to set and achieve challenging goals.

The hiring rate for this position is $108,960.00 -$122,580.00 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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