Job Description
Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Sr. Validation Technician is responsible for testing, troubleshooting, calibration/ certification of storage units, devices and temperature monitoring probes. This position ensures that all instruments are in a qualified state. Requires participation in environmental, engineering studies, use programs/applications to collect and evaluate temperature with the scope for travel as needed to client sites. This position requires the ability to work independently, be self-directed, communicate optimally, and use good judgment when making decisions. Internal or external client interaction occurs under the guidance of expert, professional or technical staff.
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General Duties and Responsibilities:
Works under close mentorship of validation engineer(s) to ensure all GMP equipment/instruments and devices are in a qualified/certified state.
Contributes directly to the completion of projects and is responsible for performing qualification/validation of equipment by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (cGMPs) and all other regulatory requirements.
With the guidance of validation engineer(s) prepares reports/summaries of validation testing/metrics for tracking and reporting purposes; provides day-to-day project completion; participates in process improvement activities.
Uses database applications and standard precautionary procedures.
Travels locally to other facilities as needed.
Effectively performs Validation Technician 3 duties which include:
Install/Certify environmental monitoring/recording devices.
Maintain all documentation pertaining to certifications/ qualification performed(Archival Management).
Ensure all GMP equipment/instruments and devices are in a qualified/certified state and track all validation requests. Will participate, facilitate and support validation training and project management activities as the need arises.
Coordinate assigned projects and represents department on project teams.
Serves as an information resource to contractors and vendors.
Other duties may be assigned to meet business needs.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability.
To perform this job successfully, an individual must be able to complete each essential duty.
It requires ability to communicate appropriately verbally and in written form.
Ability to prepare reports using Excel; knowledge of Windows, Word and Access preferred.
Knowledge of Universal Precautions, general laboratory and quality assurance/control needed.
Valid driver's license and good driving record if required to travel to other locations.
Education/ Experience:
Requires High School Diploma; Associate degree in life science field with ASQ or equivalent certifications preferred.
Requires hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries and basic knowledge of refrigerator and freezer operation and temperature distribution patterns in storage spaces.
Supervisory Responsibility:
None. Mentors and trains peers.
Work Schedule:
8AM to 5PM core hours, additional hours as the need arises.
Travel on a local level.
Work Conditions/Physical Requirements:
Must be able to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and marked changes in temperature.
May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
Must use personal protective equipment and adhere to safety protocols.
Must be able to lift and carry up to 50 lbs, and push up to 70 lbs; to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C); work in walk-in freezers or refrigerators periodically for up to 5 hour per day; use a computer up to 6 hours per day; and travel to client sites as needed and assigned.