CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497)

3 Key Consulting

  • Thousand Oaks, California
  • 17 days ago
  • Remote

    Highlights

    The role partners with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to assess equipment performance, maintenance history, calibration status, deviations, change controls, and overall lifecycle management. Primarily responsible for planning, coordinating, executing, and documenting periodic reviews of GMP equipment to ensure continued state of validation, compliance with regulatory requirements, and suitability for intended use.

    Numbers & Facts

    LocationThousand Oaks, California (
    Remote
    )
    Website3keyconsulting.com/careers

    Description

    Job Title: CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497)
    Location: Thousand Oaks, CA. 91320
    Employment Type: Contract
    Business Unit: Engineering Systems
    Duration: 12+ months with likely extensions and/or conversion to permanent
    Posting Date: 06/16/2026
    Pay Rate: $46 - $52/hour W2 with benefits
    Notes: Fully Remote.

    3 Key Consulting is hiring a C&Q Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

    Job Description:
    Primarily responsible for planning, coordinating, executing, and documenting periodic reviews of GMP equipment to ensure continued state of validation, compliance with regulatory requirements, and suitability for intended use.  The role partners with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to assess equipment performance, maintenance history, calibration status, deviations, change controls, and overall lifecycle management.

    Key skills and requirements:
    • Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV/validation maintenance role.
    • Knowledge of cGMP commissioning/qualification/validation practices.
    • Familiarity with biotech/pharmaceutical manufacturing equipment.
    • Familiarity with Kneat Gx Platform or other digital C&Q systems.
    • Experience working with cross-functional stakeholders.
    • Knowledge of quality assurance principles including deviations and change control systems.
    • Effective communication skills, both verbal and written.
    • Able to think analytically with the ability to resolve issues.
    • Able to manage own time efficiently.
    Position could be extended to up to 3 years

    Why is the Position Open?
    Planned Project.

    Top Must Have Skills:
    Experience in commissioning/qualification/validation, experience in a GMP environment, knowledge of biotech/pharmaceutical manufacturing equipment

    Day to Day Responsibilities:
    • Execute periodic reviews of GMP equipment according to approved procedures and schedules. Assess
     equipment records including work orders, deviations, and change control records.
    • Evaluate equipment records to verify continued fitness for intended use.
    • Generate and/or revise periodic review reports.
    • Collaborate with Manufacturing, System Owners, Validation, and Quality teams as needed.
    • Schedule and lead review meetings as needed to resolve issues.
    • Ensure reviews are completed within established timelines and regulatory expectations.
    • Maintain periodic review trackers and metrics.
    • Identify opportunities to improve the equipment periodic review process.
    • Other duties may be assigned to this role.

    Basic Qualifications:
    Master degree or Bachelor degree and 2 years of experience or Associate degree and 6 years of experience or high school diploma / GED and 8 years of experience

    Employee Value Proposition:
    Industry experience.

    Red Flags:
    Short tenures at previous jobs (<2 years)
    No experience in commissioning/qualification/validation


    Interview process:
    1-2 Stages of interview | Video interview (Teams)

    We invite qualified candidates to send your resume to 

    resumes@3keyconsulting.com

    .  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
     

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