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Computer System Validation Manager Jobs in Elkhart, IN

Note Tech Industries LLC

Computer Technician

Mishawaka, IN

$17.25 - $22.75/hr

Computer Technician Template We are looking for a motivated and highly technical Computer Technician to manage, monitor, and repair our computer systems, and also ensure that systems are configured ...

Beacon Health System

Senior Systems Analyst

Granger, IN · On-site

... computer system security. Ability to handle the most complex issues. Provides training and acts as a mentor to other Systems Analysts. Perform project management for small to large projects. Utilizes ...

Beacon Health System

Senior Systems Analyst

Granger, IN · On-site

... computer system security. Ability to handle the most complex issues. Provides training and acts as a mentor to other Systems Analysts. Perform project management for small to large projects. Utilizes ...

Safeway Auto Service

Service Manager

Warsaw, IN · On-site

Invoice and record completed work orders in computer system * Oversee employee training and ... Valid driver's license required as well as clean driving record * Professional appearance and work ...

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Computer System Validation Manager information

See Elkhart, IN salary details

$45.4K

$100.9K

$153.6K

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

As of Sep 14, 2026, the average yearly pay for computer system validation manager in Elkhart, IN is $100,861.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,300.00 and $126,300.00 per year, depending on experience, location, and employer.

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 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 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 cities near Elkhart, IN are hiring for Computer System Validation Manager jobs?

Cities near Elkhart, IN 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 Elkhart, IN as of August 2026, with employment types broken down into 87% Full Time, 12% Part Time, and 1% Contract. Highlights an 79% Physical, 3% Hybrid, and 18% Remote job distribution, with an average salary of $100,861 per year, or $48.5 per hour.

Scientist II or III - Metrology Specialist - FSP

Three Rivers, MI • On-site

Parexel
Pharmaceutical and Medicine Manufacturing • 10K+ employees
Learn more about Parexelexternal

Full-time

Retirement, PTO

Re-posted 11 days ago

Key responsibilities

  • Oversee the lifecycle of laboratory equipment, including acquisition, installation, maintenance, calibration, and retirement.

  • Coordinate service activities with vendors and service engineers, and support computer system validation activities.

  • Prepare, review, and approve documentation related to laboratory equipment such as qualification, calibration, and master equipment lists.

Parexel rating

8.2

Company rating: 8.2 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

Job description

When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are looking tofill aScientistIIorIII- Metrology Specialistposition working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clientslocatedinRahway,NJ.This position offers full benefits, sick time, 401K, paid holidays, and paid time off.This position does not offer any sponsorship.

Metrologyspecialistisresponsible for the oversight of regulated and non-regulated laboratory equipment.This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement

Qualifications-B.S./M.S.in Chemistry, Biochemistry, Engineering, or a related discipline

  • Scientist2- B.S. with1-2years of relevant experienceor M.S. with0-1years of relevant experience

  • Scientist 3- B.S. with 3-5 years of relevant experience or M.S. with 1-2 years of relevant experience

Required Skills and Experience

  • Experience working within a regulated (GMP) laboratory

  • Experiencemaintaining, operating, and troubleshooting laboratory equipment including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet-Visible spectroscopy (UV-Vis), dissolution systems, and other specialized computerized systems.

  • Familiarity with standalone computer systemGMPvalidation requirements

  • Highly organized, and capable of multi-tasking to manage a variety of laboratory equipment or system related schedules, documents, and maintenance tasks

  • Capable of working independently under moderate supervision

  • Strong verbal and written communication skills

  • Strong interpersonal skills. Comfortable interacting with a variety of on-site and off-site collaborators

  • Familiarity with authoring relevant instrument standard operating procedures (SOPs)

Responsibilities

  • Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation

  • Coordinate service activities across a variety of vendors and service engineers while building andmaintainingstrong working relationships

  • Gain a working knowledge of laboratory equipment tofacilitatewith troubleshooting and/or perform maintenance or calibration activities

  • Participate in computer system validation activities associated with new or upgraded equipment or software packages

  • Support the purchase, installation, and equipment qualification of new laboratory equipment

  • Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support

  • Originate and progress Notice of Event (NOE) and Change Management (CM) records

  • Perform and document investigations andassistin developing/implementing CAPA plans

  • Represent the laboratory on all aspects of laboratory equipment during audits

  • Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!

#LI-DK1

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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About PAREXEL

Sourced by ZipRecruiter

Bring your Data Management expertise to Parexel's Strategic Partnerships. Although we work globally, each partnership we form is deeply personal. We are as dedicated to every aspect of our client's product development as they are - and work closely with client teams in true partnership to understand both challenges and opportunities. At Parexel we are focused on meeting customer and patient needs through collaborative partnership so that we get treatments into the hands of patients who need them most.

Industry

Pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Waltham, MA, US

Year founded

1983

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