Validation Engineer

Thermo Fisher Scientific Inc. Rockville, MD

Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Validation Engineer 1 is responsible for acquiring the skills to perform testing, troubleshooting, calibration/ certification of storage units, devices and temperature monitoring probes. This position ensures that all instruments are in a qualified state. This position requires participation in environmental engineering studies, use programs/applications to collect and evaluate temperature with the scope for travel as needed to client and offsites as the subject matter experts (SME’s). The instrumentation equipment works at temperatures ranging from ambient (room temperature) to below freezing. This position uses database applications and standard precautionary procedures to work independently, be self-directed, communicate effectively, and use good judgment when making decisions. Internal or external client interaction occurs under the guidance of experienced professional or technical staff.

Essential Duties and Responsibilities:

Validation Engineer 1 duties:

Ensure all GMP equipment/instruments and devices are in a qualified/certified state. Responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements. As required, prepares reports/summaries of validation testing/metrics for tracking and reporting purposes. Is able to work independently and able to apply validation principles to work assignments, reviews and approves documents and resolves problems. Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel. Certify FBS environmental monitoring/recording devices. Participate, facilitate and/or support validation training and project management activities as required. Maintains all documentation pertaining to validation Participates on cross-functional project teams like Operations, Facilities, and Quality Assurance groups. Coordinates assigned projects and represents department on project teams. Must be able to provide day-to-day project completion guidance. Serves as an information resource to contractors and vendors. Resolves validation issues of moderate scope with limited direct supervision. Participate in process improvement activities. Assure compliance to cGMP parts 210 and 211 and company quality systems. Follow standard operating procedures (SOPs), facility safety guidelines, and Food & Drug Administration (FDA) requirements which may include compliance with cGMP CFR parts 210 and 211 where applicable. May be required to travel to other facilities to meet business needs. 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.

Requires ability to communicate effectively 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 preferred. Valid driver’s license and good driving record if required to travel to other locations.

Education/ Experience:

Requires a High School Diploma; Associate’s degree in Engineering/life science field preferred. Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries. Prefer experience with Current Good Manufacturing Practices (cGMP). Prefer ability to perform NIST traceable temperature and humidity measurements with a variety of temp/humidity measurement devices. Prefer Validation experience with Cleaning Validation; Equipment Validation; Critical Utility Systems Temperature Mapping/ Kaye Validation platform/ Controlled Temperature Units/ Freezers/Data Loggers. Prefer Qualification experience with IQ/OQ/PQ protocol development/writing/execution; GAMP; Facilities; Utilities/HVAC; Process Equipment; Final Reports. Prefer basic knowledge of refrigerator and freezer operation and temperature distribution patterns in storage spaces.

Supervisory Responsibility:

None. May train peers.

Work Schedule:

8AM to 5PM core hours, additional hours as required. Requires ability to travel on a local level. May be required to occasionally travel nationally.

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, 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. Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C). Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day. Must be able to use a computer up to 6 hours per day. Must be able to travel to client sites as needed and assigned.

Job Category Quality Country / State – City US - Maryland - Rockville Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.