Manager, Validation and Calibration (V&C)

Location
San Diego, CA, United States
Posted
Jul 18, 2018
Ref
1-167
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Position: Manager, Validation and Calibration (V&C)

Department: Validation and Calibration, Technical Operations

Reports to: Senior Director Technical Operations

Location: San Diego, California

Company Description

PaxVax develops, manufactures and commercializes innovative specialty vaccines against existing and emerging infectious diseases. PaxVax has commercial vaccines for typhoid fever (Vivotif®) and cholera (Vaxchora®), and vaccines at various stages of preclinical and clinical development for adenovirus, anthrax, chikungunya, hepatitis A, HIV and Zika. PaxVax is focused on traditionally overlooked markets, such as travel, and as part of its social mission, PaxVax is also working to make its vaccines available to broader populations most affected by these diseases. PaxVax is headquartered in Redwood City, California and maintains research and development and Good Manufacturing Practice (GMP) facilities in San Diego, California and Bern, Switzerland and other operations in Europe. More information is available at http://www.PaxVax.com.

Summary Description of Role:

The Manager of Validation and Calibration (V&C) will be responsible for activities related to the lifecycle of validated equipment and systems, including the planning, execution and documentation of validation and calibration activities, ensuring all cGxP equipment and systems are maintained in a validated and calibrated state. This position includes supervision of both, contract service providers and PaxVax personnel, as well as executing hands-on equipment validation and calibration activities.

Responsibilities:

  • Equipment, systems and process validations performed at the San Diego site
  • Manage the annual budget for the San Diego site's validation and calibration expenses
  • Develop, maintain and execute the San Diego site's Validation Policy and Validation Master Plan
  • Responsible for the scheduling and coordination of validation, calibration and maintenance activities required for cGxP equipment, systems and processes
  • Lead projects associated with validation and calibration responsibilities
  • Author validation plans, protocols and reports
  • Oversee validation and calibration activities performed by contract service providers
  • Perform IOQs and PQs of equipment, systems and processes
  • Assist with writing, reviewing and executing FATs, SATs, IOQs and PQs for equipment, systems and processes
  • Work closely with Quality, Process Development, Facilities, and Production to investigate and resolve deviations through determining root cause, product impact, and appropriate corrective and preventive actions related to equipment or validated process parameters
  • Assist in providing responses to audit observations and manage audit related CAPA commitments
  • Develop, write, and edit document such as Standard Operating Procedures (SOP), forms, checklists, protocols and reports applicable to calibration and validation related activities. Documents include SOPs for operation and maintenance of manufacturing process equipment, facilities and automation systems.
  • Responsible for the supervision, performance management and development of San Diego's validation and calibration team


Requirements:

  • Bachelor's Degree in science or engineering, or equivalent education and experience, from an accredited university or college
  • Six (6) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof
  • Two (2) or more years of supervisory/team leadership and performance management experience
  • Desirable cGxP validation experience includes Process Equipment, Utilities (including HVAC), Laboratory, Automation, Computer Systems (LIMS, Delta V, Automation Systems, BMS and MES), Sterilization, and Automated Drug Product Filling Systems
  • Proven skill in the use of thermal mapping equipment (GE/Kaye Validator 2000 a plus) in validating temperature controlled units
  • Proven skill in the use of standard calibration tools (e.g., digital multimeters, RPM meters, temperature baths, weights and measures, etc.)
  • Validation experience using risk based approaches (FMEA, PHA, etc.)
  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions
  • Excellent technical writing and verbal communication skills
  • Experience in authoring protocols, reports, User Requirements Specifications (URSs), procedures, and similar technical documents
  • 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 manage multiple activities while maintaining a high level of organization
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation 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