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Cqv Jobs in Minnesota (NOW HIRING)

CAI

CQV Senior Project Manager

Minneapolis, MN · On-site

$120K - $175K/yr

The CQV Senior Project Manager is responsible for leading services delivered to life sciences clients in all aspects of CQV-project execution and capital project Operational Readiness. Skills and ...

CAI

CQV Senior Project Manager

Minneapolis, MN

$120K - $175K/yr

The CQV Senior Project Manager is responsible for leading services delivered to life sciences clients in all aspects of CQV-project execution and capital project Operational Readiness. Skills and ...

Peet's Coffee

Maintenance Manager

Brooklyn Center, MN

$130K - $145K/yr

Direct equipment installation and start-up activities, establishing and enforcing Commissioning, Qualification, and Validation (CQV) standards to ensure regulatory readiness, complete documentation ...

PSC Biotech

Validation Engineer

Minneapolis, MN · On-site

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. * 3+ years of validation, CQV, or qualification experience within pharmaceutical, biotechnology, or regulated ...

PSC Biotech

Cleaning Validation Engineer

Minneapolis, MN

$90K - $105K/yr

Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related technical discipline. * 3+ years of experience in Cleaning Validation, CQV, Validation, or Quality Engineering within ...

PSC Biotech

Cleaning Validation Engineer

Minneapolis, MN · On-site

$90K/yr

Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related technical discipline. * 3+ years of experience in Cleaning Validation, CQV, Validation, or Quality Engineering within ...

PSC Biotech

Validation Engineer

Minneapolis, MN · On-site

$90K - $105K/yr

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. * 3+ years of validation, CQV, or qualification experience within pharmaceutical, biotechnology, or regulated ...

PSC Biotech

Validation Engineer

Minneapolis, MN

Requirements Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. 3+ years of validation, CQV, or qualification experience within pharmaceutical, biotechnology, or ...

All JobsCqv JobsCqv Jobs in Minnesota

Cqv information

What is a CQV?

A CQV (Commissioning, Qualification, and Validation) job involves ensuring that equipment, systems, and processes in industries like pharmaceuticals and biotechnology meet regulatory and operational requirements. CQV professionals develop protocols, execute tests, and document compliance to ensure that facilities maintain safety and efficacy standards. They work closely with engineers, quality teams, and regulatory bodies to achieve validated systems.

What are the most common challenges faced by CQV specialists in the pharmaceutical industry?

CQV specialists in the pharmaceutical industry frequently encounter challenges such as managing tight project deadlines, adapting to evolving regulatory requirements, and coordinating across multi-disciplinary teams. Balancing compliance with operational efficiency demands a thorough understanding of documentation and attention to detail. Working with new or complex equipment can also present learning curves that require problem-solving and collaboration with engineering, production, and quality assurance teams. However, overcoming these challenges offers valuable experience and opportunities to build a robust skill set highly regarded in regulated industries.

What are the key skills and qualifications needed to thrive in the CQV position, and why are they important?

To thrive as a CQV (Commissioning, Qualification, and Validation) specialist, you need a strong background in engineering or life sciences, along with expertise in equipment qualification, validation protocols, and regulatory compliance. Familiarity with industry standards such as cGMP, FDA, and tools like validation software and document management systems is highly valuable. Strong analytical thinking, attention to detail, communication, and teamwork skills are crucial for ensuring project success and regulatory adherence. These skills ensure that pharmaceutical and biotech manufacturing processes meet rigorous quality standards and regulatory requirements.

What are popular job titles related to Cqv jobs in Minnesota? For Cqv jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Cqv jobs in Minnesota look for? The top searched job categories for Cqv jobs in Minnesota are:
Cqv jobs near you
Infographic showing various Cqv job openings in Minnesota as of August 2026, with employment types broken down into 100% Full Time. Highlights an 74% In-person, and 26% Remote job distribution.

Senior CQV Engineer / Validation Lead

Pinnaql

Chaska, MN • On-site

Full-time

Re-posted 25 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
  • Senior CQV Engineer / Validation Lead

Position Summary
The Senior CQV Engineer / Validation Lead will be responsible for the planning, authoring, execution, and completion of Commissioning, Qualification, Validation (CQV), and Process Qualification activities associated with laboratory, manufacturing, and process equipment. This is a hands-on role requiring the individual to independently develop validation documentation, execute qualification protocols, manage deviations, analyze results, and prepare final reports while coordinating activities with Engineering, Manufacturing, and Quality teams.
The resource will support qualification activities for laboratory instrumentation, biosafety cabinets, labeling systems, filling and capping equipment, process equipment, bioreactors, AKTA systems, freezers, lyophilizers, autoclaves, washers, and associated manufacturing systems.
Primary Responsibilities
Validation Planning & Risk Assessment
  • Develop Validation Plans and Qualification Strategies for assigned systems.
  • Conduct System Impact Assessments (SIA) and Risk Assessments.
  • Define CQV deliverables, acceptance criteria, and testing approaches.
  • Participate in project planning meetings and provide technical CQV guidance.
  • Maintain document tracking systems and status reports for validation deliverables.

Protocol Authoring
  • Independently author and revise:
    • FAT Protocols
    • SAT Protocols
    • IQ Protocols
    • OQ Protocols
    • PQ Protocols
    • IOQ Protocols
    • Validation Summary Reports
    • Qualification Traceability Matrices
  • Generate User Requirement Specifications (URS) when required.
  • Develop test scripts, data sheets, and supporting qualification documentation.
  • Route documents through review and approval cycles.

Protocol Execution
  • Execute IQ, OQ, PQ, and IOQ protocols in the field.
  • Perform equipment walkdowns and field verification activities.
  • Coordinate testing with Engineering, Manufacturing, Vendors, and Quality.
  • Document test results and supporting evidence.
  • Support FAT and SAT activities as required.
  • Ensure all testing is performed in accordance with approved protocols and GMP requirements.

Deviation Management & Final Reporting
  • Identify, document, investigate, and resolve deviations encountered during qualification activities.
  • Support CAPAs and Change Controls impacting qualified systems.
  • Analyze qualification results and assess acceptance criteria.
  • Author final qualification reports and validation summary reports.
  • Support system release into GMP operation.

Process Qualification & Characterization
  • Perform characterization studies and process qualification activities.
  • Support qualification of:
    • Filling systems
    • Capping systems
    • Cap inspection systems
    • Labeling systems
    • Check-weighing systems (including Gage R&R activities)
    • Complete fill-line process operations
    • Generate and execute OQ and PQ protocols.
    • Compile and analyze process qualification data.

Documentation Support
  • Develop and revise equipment SOPs.
  • Develop and update manufacturing batch records.
  • Maintain validation lifecycle documentation.
  • Ensure compliance with GMP documentation practices and site procedures.

Specific Activities Included in Scope
The resource may be required to author, execute, and report on activities such as:
  • Desktop Printer IOQ
  • Flat Box Labeler IOPQ
  • CalCheck IOQ
  • Tube Labeler FAT and IOQ
  • SureTorque IOQ
  • BioSafety Cabinet IOQ
  • Filling Line Characterization
  • Capping System Characterization
  • Labeling System Qualification
  • Check Weighing System Qualification and Gage R&R
  • LTP Line OQ and PQ Generation
  • LTP Line OQ and PQ Execution
  • Final Qualification Reporting
  • Equipment SOP Development
  • Batch Record Development

These activities are based on the currently identified CQV work packages and may be adjusted as project priorities evolve.
Required Qualifications
  • Bachelor's Degree in Engineering, Life Sciences, or related technical discipline.
  • Minimum 8-10 years of CQV, Validation, Qualification, or Process Validation experience within pharmaceutical, biotechnology, or medical device environments.
  • Demonstrated experience authoring and executing IQ/OQ/PQ protocols.
  • Strong knowledge of GMP regulations, FDA guidance, ASTM E2500, GAMP, and ISPE methodologies.
  • Experience managing deviations, investigations, CAPAs, and Change Controls.
  • Strong technical writing skills.
  • Ability to work independently with minimal supervision.

Preferred Experience
  • AKTA Systems
  • Bioreactors
  • Biosafety Cabinets
  • Lyophilizers
  • Autoclaves and Washers
  • Labeling Systems
  • Filling and Capping Equipment
  • Laboratory Instrumentation
  • Calibration Systems
  • Freezers and Controlled Temperature Equipment

Work Location
Remote Activities
  • Validation Planning
  • Risk Assessments
  • Protocol Authoring
  • URS Development
  • SOP Development
  • Batch Record Development
  • Final Report Preparation
  • Data Review and Analysis

On-Site Activities
  • Equipment Walkdowns
  • Protocol Execution
  • FAT/SAT Support
  • Field Verification
  • Deviation Resolution
  • Characterization Studies
  • OQ/PQ Execution
  • System Release Activities

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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