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QA Equipment Validation Engineer (req1904)

Company: Frederick National Laboratory
Location: Frederick
Posted on: July 17, 2021

Job Description:

KEY ROLES/RESPONSIBILITIES

  • Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at the cGMP Vaccine Pilot Plant
  • Write and execute equipment validation (IOPQ) and requalification (RQ) protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards
  • Write and participate in execution of Aseptic Process Simulations in conjunction with manufacturing and Quality Control departments
  • Compile validation packages including protocol deviations and testing documents
  • Write validation summary reports for IOPQ, RQ, and Aseptic Process Qualification protocols as required
  • Assist with validation activities as required including peer review of executed IOPQ, RQ, and Aseptic Process Qualification protocols
  • Assist with factory acceptance testing (FAT) and site acceptance testing (SAT) as required
  • Maintain detailed documentation of all operations performed and comply with FDA current Good Manufacturing Practices (cGMP)
  • Adhere to approved outlined processes and maintain detailed documentation
  • Work closely with, and occasionally supervise, validation contractors
  • Participate in the generation and review of operation, maintenance, calibration, and cleaning SOPs to assure adherence to approved validation procedures

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of two (2) years job related experience to include process, equipment and/or system validation
  • Knowledge of current regulatory expectations and industry standards relating to equipment validation
  • Ability to perform thermal mapping using a standard GE-Kaye Validator 2000
  • Experience with general laboratory equipment (refrigerators, incubators), process equipment (autoclaves, bioreactors, depyrogenation ovens, and/or isolators) and utilities (clean steam, Water for Injection (WFI) and Heating Ventilation and Air Conditioning (HVAC) systems), and aseptic processes
  • Knowledge of mechanical and engineering principles, maintenance, and calibration procedures used for equipment and associated instrumentation
  • Experience troubleshooting systems/equipment
  • Experience with equipment operated by programmable logic controllers (PLC) and human machine interfaces (HMI)
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:
  • Job related experience to include process, equipment and/or system validation
  • Experience in a cGMP environment (Biologics preferred)
  • Experience in sterilization cycle development, cleaning validation, aseptic process qualification, environmental monitoring qualification, conducting FAT and SAT, commissioning, and qualification.
  • Experience with non-conformance documentation including deviations, investigations, Corrective Actions, Preventive Actions, and change controls
  • Experience with facilities work request systems, such as Regulatory Asset Manager (RAM)
  • Ability to meet published timelines

JOB HAZARDS
  • This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job


Keywords: Frederick National Laboratory, Frederick , QA Equipment Validation Engineer (req1904), Other , Frederick, Maryland

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