CQV Consultant

Sacramento, CA, US • Posted 1 day ago • Updated 1 day ago
Contract Independent
Contract W2
Contract Corp To Corp
6 Months
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • Biotechnology
  • Life Sciences
  • Manufacturing
  • GAMP
  • GMP
  • IQ
  • Pharmaceutics
  • OQ
  • Computerized System Validation
  • CSV
  • Regulatory Compliance
  • ICH
  • 21 CFR
  • Quality Assurance

Summary

Onsite in Sacramento, California

CQV Consultant .

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.

Computer System Validation (CSV)

  • Support CSV activities associated with equipment software, automation systems, and equipment-to-system interfaces.
  • Review software configuration documentation and validation evidence.
  • Assist in validation of GMP computerized systems associated with manufacturing operations.

Required Qualifications

Education

  • Bachelor s degree in engineering, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related discipline.

Experience

  • 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.
  • Exposure to commissioning and startup activities

Regulatory Knowledge

  • cGMP
  • 21 CFR Part 11
  • GAMP 5
  • ICH Q9
  • ICH Q10
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: 8985855
  • Posted 1 day ago
Contact the job poster
Vishal Jadhav

Vishal Jadhav

Recruitment Specialist @ SmartIMS Inc.
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