Validation Technician

at  Thermo Fisher Scientific

JOB DESCRIPTION

This remarkable position at Thermo Fisher Scientific allows you to play a role in advancing cell therapy and high-value biologics. Join the Validation team and help deliver the services in Cold Chain management
Location:
14665 Rothgeb Drive
Rockville, MD
8 AM to 5 PM core hours, additional hours as needed.
Job Description:
Travel to various Maryland locations to test, troubleshoot, and calibrate/certify storage units, devices, and temperature monitoring probes.
Requires ability to travel locally and occasionally nationally. Valid driver’s license and good driving record as travel is required.
Ensure that all instruments are in their qualified states.
Participate in environmental and engineering studies and use programs/applications to collect and evaluate temperature data.
Work independently, communicate efficiently, and make use good judgment skit in decision-making.
Develop and modify SOPs and WIs related to the validation process. Write reports, procedures, and protocols for cold chain engineering studies for client-specific and internal projects.
Perform validation on equipment, utility systems, processes, and automation systems in compliance with approved SOPs and regulatory requirements.
Maintain a database of validation, and calibration/certification activities in Maximo.
Complete projects as planned, developing validation change control documents.
Complete assigned projects and represent the department on project teams.
Participate, facilitate, and support validation training and project management activities.
Work closely with multi-functional project teams consisting of Operations, Facilities, and Quality Assurance groups.
Help in resolving validation issues with limited direct supervision.
Have effective communication skills, both verbal and written; be proficient in Excel, Windows, Word, Maximo and TrackWise software.
Have the knowledge of Universal Precautions.
Demonstrate good professional judgment when working with clients and other departments.
Be able to independently accomplish tasks without constant supervision.

Education:

• High School Diploma or equivalent experience is required; but Associate degree in Engineering/Life Science field is preferable.

Experience:

• 2+ years of hands-on experience in cGMP/Biotech/Biopharmaceutical/FDA-regulated industry.

Knowledge & Skills:

• 30% travel.
• Knowledge of conducting temperature mapping studies, including the operation of Validation Temperature data procurement equipment.
• Able to work in cold environments with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents. May push/pull 600 lb. liquid nitrogen dewars and work from a platform ladder. Use personal protective equipment to meet safety protocols.
• Lift and carry up to 50 lbs. and push up to 70 lbs.
• Process and handle materials frozen on dry ice or liquid nitrogen.
• Work in walk-in freezers or refrigerators periodically for up to 5 hours daily.
• Use the computer up to 6 hours daily.

Please refer the Job description for details