CQV Consultant (Utilities & GMP Equipment)

Sacramento, CA, US • Posted 1 day ago • Updated 1 day ago
Contract W2
Contract Corp To Corp
12 Months
No Travel Required
Able to Sponsor
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • Commissioning Qualification Validation
  • CQV
  • GMP
  • CSV
  • IQ/OQ/PQ protocols
  • Utility Systems
  • Validation & Compliance
  • Regulatory
  • Equipment

Summary

**** Onsite Role ****

 Position Summary

The selected candidate will be responsible for commissioning, qualification, and validation activities related to GMP utilities, manufacturing equipment, process systems, and supporting infrastructure within a regulated biotech environment. The role requires strong expertise in qualification lifecycle management, GMP compliance, equipment validation, and cross-functional collaboration with Engineering, Manufacturing, Quality Assurance, and Validation teams.

Key Responsibilities

  • Commissioning, Qualification & Validation (CQV)
  • GMP Compliance & Documentation
  • Cross-Functional Collaboration
  • Computer System Validation (CSV)

Required Qualifications

  • Bachelor’s degree in engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related discipline.
  • Minimum 5+ years of experience in CQV within pharmaceutical, biotechnology, or regulated manufacturing environments.
  • Hands-on experience executing IQ/OQ/PQ protocols.
  • Experience with GMP manufacturing equipment and utility qualification.

Technical Skills

Equipment Qualification

  • Bioreactors
  • Fermenters
  • CIP/SIP Systems
  • Chromatography Systems
  • Process Vessels
  • Filling Equipment
  • Packaging Equipment

Utility Systems

  • Purified Water Systems
  • Water for Injection (WFI)
  • Clean Steam Systems
  • HVAC Systems
  • Compressed Air Systems
  • Nitrogen Systems
  • Environmental Monitoring Systems

Validation & Compliance

  • Qualification Lifecycle Management
  • Risk Assessments
  • Change Control
  • Deviation Management
  • CAPA
  • Validation Documentation

Regulatory Knowledge

  • cGMP
  • 21 CFR Part 11
  • GAMP 5
  • ICH Q9
  • ICH Q10

 Preferred Qualifications

  • Biotechnology manufacturing experience.
  • Experience with automation systems and SCADA interfaces.
  • Exposure to DeltaV, Rockwell, Siemens, or similar control systems.
  • Prior experience supporting FDA, EMA, MHRA, or other regulatory inspections.
  • Knowledge of Computer System Validation (CSV) and Computer Software Assurance (CSA).
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: SMARNJ
  • Position Id: 8985813
  • Posted 1 day ago
Contact the job poster
Adithya Sastrulavari

Adithya Sastrulavari

Recruiter @ SmartIMS Inc.
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