Senior CQV Engineer

Thousand Oaks, CA, US • Posted 60+ days ago • Updated 9 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Startups
  • Editing
  • Manufacturing
  • Quality Control
  • Quality Assurance
  • Leadership
  • Management
  • Root Cause Analysis
  • Life Sciences
  • Pharmaceutics
  • Computerized System Validation
  • Good Manufacturing Practice
  • GAMP
  • Documentation
  • Analytical Skill
  • Conflict Resolution
  • Problem Solving

Summary

Job Summary :
  • The Senior CQV Engineer will play a critical role in the successful startup and qualification of a new early-phase clinical biomanufacturing facility, encompassing cleanrooms, utilities, and a wide range of systems and equipment.
  • This position is responsible for planning, executing, and documenting commissioning, qualification, and validation (CQV) activities to ensure all systems meet stringent regulatory and client-specific requirements
  • Roles & Responsibilities:
  • uthoring, editing, and executing technical commissioning, qualification and validation documentation for facilities, utilities, and standard equipment/systems/software
  • ctively consulting clients on regulatory validation processes and standard industry acceptable practices
  • Collaborating with cross-functional teams including Manufacturing, Facilities, Quality Control and Quality Assurance to ensure validation activities are properly scoped and executed
  • Taking independent leadership role on project(s)
  • Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities- including ability to complete root cause analysis.
  • Education & Experience :
  • Bachelor's degree in engineering, Life Sciences, or a related field
  • 5+ years of relevant experience in validation within a regulated industry (e.g., pharma, biotech)
  • Experience with facility, utility, equipment, and computer system validation. Preferably in start-up of early-phase clinical biomanufacturing facilities
  • Strong knowledge of validation principles, cGMP, FDA regulations (21 CFR Part 11, Part 210/211), and industry guidelines (e.g., ISPE, GAMP)
  • Experience working with start-up clients, without well established company procedures and standards
  • Excellent documentation, analytical, and problem-solving skills
  • bility to work independently and as part of a team
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: 72d3db6529e29fa8717a8f412a04cdb7
  • Posted 30+ days ago
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