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

3 Key Consulting
  • Thousand Oaks, California
  • Remote
  • $46–$52 Per Hour
  • Autofill and Review
30+ days ago

Job Description

Job Title: CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497)Location: Thousand Oaks, CA. 91320Employment Type: ContractBusiness Unit: Engineering SystemsDuration: 12+ months with likely extensions and/or conversion to permanentPosting Date: 06/16/2026Pay Rate: $46 - $52/hour W2 with benefitsNotes: 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 yearsWhy 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 equipmentDay 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 experienceEmployee Value Proposition: Industry experience.Red Flags:Short tenures at previous jobs (No experience in commissioning/qualification/validationInterview 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.

Numbers & Facts

LocationThousand Oaks, California (
Remote
)
Salary$46–$52 Per Hour

Skills

  • Analysis Skillsunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • C Programming Languageunmatched
  • Calibrationunmatched
  • Change Controlunmatched
  • Commissioningunmatched
  • Communication Skillsunmatched
  • Consultingunmatched
  • Control Systemsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Documentationunmatched
  • Drug Manufacturingunmatched
  • Equipment Maintenance/Repairunmatched
  • Fitnessunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • High School Diplomaunmatched
  • Manufacturingunmatched
  • Manufacturing Equipmentunmatched
  • Manufacturing Systemsunmatched
  • Metricsunmatched
  • Performance Analysisunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Project Planningunmatched
  • Quality Assuranceunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • System Validationunmatched
  • Writing Skillsunmatched

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