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Computer System Validation Manager Jobs in Minnesota

DivIHN Integration Inc

R&D IT Site Lead

Plymouth, MN · On-site

Experience with IT asset management and compliance. Strong understanding of GxP workstation and IT QA activities, including IQ/OQ and computer system validation. Experience with helpdesk ticketing ...

Marvin

Computer Systems Tech II

Eagan, MN · On-site

System & Network Maintenance * Perform routine maintenance on operating systems, applications, and ... Asset & Inventory Management * Maintain accurate inventory of IT hardware, software, and licenses.

Marvin

Computer Systems Tech II

Eagan, MN · On-site

System & Network Maintenance * Perform routine maintenance on operating systems, applications, and ... Asset & Inventory Management * Maintain accurate inventory of IT hardware, software, and licenses.

Mas Hvac

CAD Manager

Maple Grove, MN · On-site

$90K - $110K/yr

Position Summary The CAD Manager is responsible for leading and developing the Mechanical Design and Drafting team while establishing and maintaining the systems, standards, and processes that ...

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Computer System Validation Manager information

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 are popular job titles related to Computer System Validation Manager jobs in Minnesota?

For Computer System Validation Manager jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in Minnesota look for?

The top searched job categories for Computer System Validation Manager jobs in Minnesota are:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Minnesota as of September 2026, with employment types broken down into 50% Full Time, and 50% Contract. Highlights an 100% In-person job distribution.

Advanced Assay Office/Validation Analyst

Minneapolis, MN • On-site

Bio-Techne
Biotechnology Research and Development • 1 - 5K employees
Learn more about Bio-Techneexternal

$55K - $91K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 5 days ago

Key responsibilities

  • Perform assay value assignment and prepare assay sheet data for entry into templates.

  • Collaborate with the Product Validation Manager to write and review validation summaries and reports.

  • Review product finishing and laboratory records, complete release documents, and prepare Certificates of Analysis (COAs) for OEM customers.

Bio-Techne rating

8.4

Company rating: 8.4 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

Job description

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$55,600.00 - $91,450.00
Position Summary:
The responsibilities of this position include all aspects of assay value assignment and assisting with product validation activities. Responsibilities include organizing, analyzing, and evaluating internal and external data for the assignment of assay values comparing selected assay values to release specifications as well as compiling validation data for report generation.
Key Responsibilities:
  • Perform assay value assignment.
  • Perform appropriate calculations and prepare assay sheet data for entry into assay sheet templates.
  • Maintain product history used for value assignments and monitors quality of assay values.
  • Maintain knowledge of instrument theory and methodology.
  • Write and maintains Assay Office procedures for value assignment and related procedures.
  • Collaborate with Product Validation Manager to write and review validation summaries and reports.
  • Review Product Finishing and Laboratory records and completes release documents.
  • Maintain Batch Records.
  • Prepare COAs for Original Equipment Manufacturer (OEM) customers. Reviews all copies.
  • Proofreading Certificates of Analysis (COAs), assay sheets, and other proofing as needed.
  • Coordinate customer data and QC laboratory testing.
  • Assist with calibration decisions for internal laboratory analyzers during whole blood calibration.
  • Prepare validation documents in accordance with Bio-techne electronic documentation management system protocols. Follows applicable standard operating procedures (SOPs), including a good understanding of quality associated SOPs.
  • Collaborate with Quality Assurance and Regulatory Affairs on validation summaries and reports. Knowledge of CLSI EP05 and ISO 13485 is desired.
  • Maintain confidentiality of records, data, and other information relating to the company's interests.
  • Follow company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.
  • Perform additional duties as assigned.

QUALIFICATIONS
Education and Experience:
  • This position requires a BS degree in Medical Technology or Biological Sciences or equivalent combination of education and related clinical laboratory experience.
  • 3-5 years of related experience in a lab or quality assurance setting.
  • Experience in Hematology preferred.

Knowledge, Skills, and Abilities:
  • Knowledge of laboratory equipment
  • Knowledge of company procedures and practices.
  • Skills in assisting customers in a professional manner.
  • Skills in problem solving; including the ability to identify and appropriately evaluate a course of action.
  • Ability to lead and act independently on routine assignments or projects.
  • Ability to plan, organize and multi-task to complete assignments in an efficient manner.
  • Ability to communicate professionally, both oral and written.
  • Ability to pay attention to details and perform at a high-level accuracy.
  • Ability to work independently and with a team.
  • Ability to work hours that conform to standard business operations.
  • Good communication skills, data analysis skills, and computer skills required.
  • Working knowledge of Microsoft Word and Excel is required.
  • Computer entry and/or typing skills are required.
  • Must be able to work in a fast-paced environment and multitask.

Working Conditions:
  • Standard schedule hours with occasional variation depending on production needs.
  • Onsite work required during standard business hours.

Physical Requirements:
  • Ability to work at a computer for extended periods.
  • Ability to lift and handle materials weighing 5-20 lbs.
  • Ability to work at a computer for extended periods.
  • Minimal physical demands beyond standard office requirements.

Why Join Bio-Techne:
  • We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
  • We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
  • We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
  • We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
  • We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
  • We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact hr@bio-techne.com for assistance.

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