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Calibration Validation Specialist/Engineer

Applied Molecular Transport
South San Francisco, CA
  • Expired: January 13, 2023. Applications are no longer accepted.
Position Summary:

Perform and appropriately document the calibration, qualification, troubleshooting, and repair of a variety of analytical, manufacturing, and facility equipment. Assist in the development of in-house qualification, calibration and maintenance procedures; and provide knowledgeable customer service to equipment owners. Responsible for the execution of the metrology functions required to support the facility and process equipment. Perform calibrations and schedule vendor calibrations of instrumentation and equipment. Repair and troubleshoot electronics and instrumentation as well as other equipment as able. Design and prepare all protocols and reports related to diverse validation activities. Focus on Cleaning, Equipment, Utilities, and Software Validation.

Key Responsibilities:

  • Adhere to Good Manufacturing Practices (GMPs), including adherence to all company SOPs and documentation standards
  • Design, develop, implement and maintain calibration processes and procedures for new and existing equipment and instrumentation and train key personnel on proper use.
  • Coordinate and perform calibration of instrumentation necessary for maintaining production equipment, laboratory equipment and other auxiliary measurement systems.
  • Perform routine calibrations and requalifications as required, as well as non-routine calibrations and requalifications as business needs dictate
  • Maintains detailed calibration records.
  • Maintain clear, concise, and compliant records of all work performed for the purpose of documenting the control of all equipment and utilities
  • Review calibration documents for accuracy and completeness
  • Execute and report temperature mapping studies of controlled storage equipment
  • Write and execute equipment qualification protocols for laboratory, manufacturing, and facility equipment and report protocol execution results
  • Clearly communicate calibration/requalification schedules and equipment status with Equipment Owners
  • Maintain metrology standards in working condition and ensure that they are used within their calibration intervals
  • Schedule and escort contract calibration and validation providers, and review their documents for accuracy
  • Assist in gathering and shipping equipment that requires off-site calibration.
  • Write and/or review calibration procedures, calibration specifications and calibration worksheets.
  • Provide guidance to Equipment Owners regarding the selection and maintenance of equipment.
  • Move and install equipment, when required
  • Perform both scheduled and unscheduled maintenance on laboratory, facility, and manufacturing equipment, when required
  • Assist in calibration and validation document management, including data entry and filing
  • Apply engineering principles to generate solutions to problems.
  • Assist in programming, maintenance and troubleshooting of programmable logic controllers and process/environmental monitoring systems.

  • Apply cGMP guidelines to all aspects of validation.
  • Established procedures with some supervision.
  • Write, execute, and approve validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of new and existing processes, equipment, systems, etc.
  • Write summary reports, following good documentation practices.
  • Use Kaye Validator or other dataloggers to perform mapping studies.
  • Analyze statistical data to verify acceptable criteria.
  • Develop testing strategies and rationale for equipment/systems.
  • Provide technical support/troubleshooting for process and equipment issues.
  • Maintain close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation.
  • Investigate/resolve deviations associated with validation studies.
  • Assist with commissioning, FATs, and SATs.
  • Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
  • Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues.
  • Critically review complex data to ensure completeness, accuracy, and compliance.
  • Write and revise SOPs and Master Plans biennially or as part of process improvements.
  • Assist in cleaning validation activities and plans associated with projects at the site.

Preferred Experience/Education:
  • Bachelor's degree in engineering / related discipline with 2-5 years' experience or High School diploma with 5-10 years' experience
  • Job experience in a pharmaceutical manufacturing environment required.
    Experience in industrial/pharmaceutical metrology setting preferred

Knowledge, Skills and Abilities:
  • Detailed knowledge of calibration procedures and basic knowledge of programmable logic controllers is preferred
  • Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and cGMP manufacturing is very desirable.
  • Experience with Blue Mountain Computerized Maintenance Management Software is preferred
  • Strong organization and communication skills; high level of personal/departmental accountability and responsibility.
  • Ability to manage multiple priorities and tasks in a dynamic environment.
  • Excellent written and verbal skills.
  • Ability to exercise judgment to determine appropriate corrective actions.
  • Ability to use computer programs such as Microsoft Office, EDMS, and SAP.
  • Ability to work in a team environment.
  • Ability to make sound decisions regarding compliance-related issues with moderate supervision and guidance.

AMT is an equal opportunity employer. In accordance with applicable law, AMT does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

South San Francisco, CA Pay Range

$88,847 - $104,299 USD

Applied Molecular Transport


South San Francisco, CA
94083 USA