The Validation Engineer is responsible for applying the skills to perform testing, troubleshooting, calibration/certification, and repair on a variety of instrumentation and environmental storage equipment to ensure precision and accuracy. This position requires participation in environmental engineering studies as required. May use programs to collect and evaluate operating data to conduct on-line adjustments to products, instruments, or equipment.
A day in the Life:
*Write Installation, Operational, and Performance Qualification Protocols for storage units. Develop standard operating procedures.
*Ensure all GMP equipment/instruments and devices are in a qualified/certified state.
*Maintain asset management database of PM, validation, and calibration/certification activities
*Responsible for performing validation of equipment, utility systems, facilities, computer systems, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
*Must design, develop and modify SOP's, SWI's related to validation/qualification process, protocols, reports and procedures as the subject matter expert while working in teams.
*Develop and execute cold chain engineering studies geared towards client specific and internal projects.
*Certify environmental monitoring/recording devices.
*Participate, facilitate and/or support validation training and project management activities as required.
Education
*High school diploma; Associate's degree in Engineering/life science field preferred (A-level or equivalent).
Experience
*Hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industry.
*Experience with related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control.
*Knowledge of conducting temperature mapping studies, including the operation of Kaye data loggers, or equivalent.
*Requires ability to work independently using Trackwise software.
Knowledge, Skills, Abilities
*Knowledge of refrigerator and freezer operation and temperature distribution patterns in such storage spaces.
*Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations
