CQV Engineer

Austin, TX, US • Posted 30+ days ago • Updated 3 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Attention To Detail
  • Data Integrity
  • Test Scripts
  • Regulatory Compliance
  • Quality Assurance
  • Manufacturing
  • Corrective And Preventive Action
  • GMP
  • GxP
  • Auditing
  • Inspection
  • Biotechnology
  • Pharmacy
  • Pharmaceutics
  • Life Sciences
  • IQ
  • OQ
  • GAMP
  • Computerized System Validation
  • Communication
  • Analytical Skill
  • Documentation

Summary

Job Summary:
We are seeking a motivated and detail-oriented Validation / CQV Engineer to support qualification and validation activities in a regulated pharmaceutical/biotech environment. The ideal candidate will have hands-on experience in IQ/OQ execution, Computer System Validation (CSV), and validation documentation while ensuring compliance with regulatory standards including 21 CFR Part 11, ALCOA principles, and GAMP guidelines. The role involves working with laboratory systems and environmental monitoring (EM) systems to support compliance, quality, and operational readiness.

Roles & Responsibilities:
  • Execute and document IQ/OQ (Installation Qualification / Operational Qualification) protocols and activities.
  • Support Commissioning, Qualification, and Validation (CQV) activities for laboratory and manufacturing systems.
  • Perform Computer System Validation (CSV) activities in accordance with GAMP methodologies and regulatory requirements.
  • Ensure compliance with 21 CFR Part 11 and ALCOA data integrity principles.
  • Support validation lifecycle documentation including protocols, test scripts, reports, deviations, and change controls.
  • Work with Lab Systems and Environmental Monitoring (EM) Systems to ensure validated state and compliance.
  • Coordinate with Quality Assurance, Engineering, Manufacturing, and IT teams during validation activities.
  • ssist in investigations, deviations, CAPA, and remediation activities related to validation systems.
  • Maintain accurate validation records and ensure documentation follows GMP/GxP requirements.
  • Participate in audits and inspection readiness activities as required.

Education & Experience:
  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or related technical field.
  • Experience in pharmaceutical, biotech, or regulated life sciences industry preferred.
  • Hands-on experience with IQ/OQ execution and validation documentation.
  • Knowledge of 21 CFR Part 11, ALCOA, and GAMP guidelines.
  • Experience with Computer System Validation (CSV) preferred.
  • Familiarity with Lab Systems and Environmental Monitoring (EM) Systems.
  • Strong communication, analytical, and documentation skills.
  • bility to work effectively in cross-functional regulated environments.
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: 91116760
  • Position Id: 7ad8b489697359d0af0d77a7ac50a134
  • Posted 30+ days ago
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