Calibration/Validation Technician

Department
Validation, Calibration, Maintenance (VCM)

Location
San Diego

Summary Description
The Calibration/Validation Technician will be responsible for activities related to the lifecycle of qualified equipment and systems, ensuring calibration activities meet requirements to meet and maintain regulatory compliance. The position will require hands-on equipment calibration and validation activities, and the supervision of calibration/validation contractors.

Responsibilities:

  • Follow all Calibration and Validation Policies
  • Ability to assess and evaluate various types of laboratory equipment for proper calibration requirements
  • Monitor and Trend calibration data
  • Maintain equipment database for calibration and validation activities.  Coordinate calibrations and schedules with equipment owners and ensure calibration/validation activities are performed on schedule
  • Supervise/escort contract service providers when necessary
  • Work closely with Quality, Process Development, Facilities, and Production to investigate and resolve deviations associated with equipment calibration
  • Assist in providing responses to audit observations and CAPA commitments related to calibration activities
  • Author/Assist in the development, writing, and revising of calibration related Standard Operating Procedures (SOP), forms, specifications and other required documents
  • Maintain calibration and validation standards
  • Ability to work within cleanroom environments to perform calibration/validation activities

Qualification Requirements:

  • 3 or more years of relevant experience in calibration activities in a biopharmaceutical manufacturing environment
  • Willingness to learn and perform some basic equipment qualification procedures including temperature mapping of controlled temperature units
  • Able to communicate efficiently and effectively among VCM team, other PaxVax department members, and any outside contract service providers/vendors
  • Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity

Technical Skills and Knowledge:

  • GMP calibration experience associated with process equipment, utilities, and laboratory equipment
  • Proven skill in performing calibration checks for various types of equipment and instrumentation used in research and manufacturing
  • Experience with deviations and investigations into calibration failures and determination of product impact potential, root cause, and corrective action
  • Excellent technical writing and verbal communications skills
  • Ability to read/interpret engineering drawings and design documents
  • Ability to work as part of a high performing team and collaborate effectively with staff at all levels
  • Demonstrated ability to execute multiple activities while maintaining a high level of organization
  • Demonstrates initiative, ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals.
APPLY FOR THIS JOB