Job: Sr. Validation Engineer – Carlsbad

Title Sr. Validation Engineer – Carlsbad
Categories California
Salary Up to $120K annually
Location Carlsbad, CA
Job Information

Opportunity

Our Client is seeking a Senior Validation Engineer for the Carlsbad Viral Vector Manufacturing Facility. This position is responsible for developing, reviewing, and executing validation activities, and ensuring that the qualification/validation activities are consistent with user’s and manufacturer’s requirements and site quality standards.

Why Work Here

  • An agile organization relentlessly focused on building on our global technology leadership and establishing a reputation for quality, safety and reliability
  • Honored by Encina Wastewater Authority (EWA) with its prestigious Gold Award, which requires that businesses meet stringent discharge limits and undergo unannounced inspections and sampling
  • Received the “Excellent Performance Award” by the world’s largest dedicated semiconductor foundry, Taiwan Semiconductor Manufacturing Company Limited (TSMC)

Responsibilities

  • Develop and validate autoclave sterilization cycles per current regulatory requirements (EN285, etc.)
  • Develop and maintain sterilization and equipment re-qualification program using risk-based approach
  • Create and execute IQ/OQ/PQ protocols/reports for equipment (Manufacturing and Lab equipment) and utilities (CDA, CO2, HVAC, Water Systems)
  • Perform risk assessments/FMEAs for equipment
  • Act as technical lead for a cross-functional projects
  • Support site expansion project to ensure validation activities are completed per site requirements
  • Work with equipment vendors to define requirements and understand functional specifications

Qualifications

  • Bachelor’s degree in Engineering or related scientific field required; Master’s degree preferred
  • 7+ years of experience with BS / 4+ years of experience with MS
  • 4+ years of experience with Equipment and Sterilization validation including autoclave sterilization
  • IQ/OQ/PQ experience for lab/manufacturing equipment and utilities
  • Working knowledge of current regulatory guidelines and standards
  • Expertise with Quality Risk Management concepts
  • Technical writing skills to create plans/protocols/reports/SOPs for validation projects

Preferred Qualifications

  • Experience in Biologics manufacturing
  • Experience supporting validation projects associated with new facilities/expansion
  • Understanding of principles and concepts of Lean Six Sigma to continuously improve qualification program

Benefits

  • Pay is commensurate with experience, $100K-$120K per year ($50-$60 per hour)
  • Optional participation in benefits plan (medical, dental, vision, 401K, etc.)
  • 1-year contract opportunity with potential for extension or direct hire

Apply

If your skills match the requirements for this exciting opportunity, please send us your resume today.

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