Validation Engineer Thermo Fisher Scientific – Rockville, MD, USA
This position is responsible for performing 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).
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.
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.
As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
Independently applies 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.
Develop and execute cold chain engineering studies geared towards client specific and internal FBS projects.
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.
May provide day-to-day guidance and training to validation technicians.
Serves as an information resource to contractors and vendors.
Resolves validation issues of moderate scope with limited direct supervision.
Key Qualifications and Education – 4+ years of hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries
Bachelors degree or higher in Engineering, Life Sciences or related discipline (Engineering, Chemical Engineering, Chemistry, Biology, etc.), preferred
Business Experience – 4+ years technical and/or manufacturing experience preferred.
Validation- Process Validation; Cleaning Validation; Equipment Validation; Critical Utility Systems Temperature Mapping/ Kaye Validation platform/ Controlled Temperature Units/ Freezers/Data Loggers; Validation Master Plans (VMP).
Qualification- IQ/OQ/PQ protocol development/writing/execution; G& Facilities; Utilities/HVAC; Process Equipment; Final Reports, etc.
Current Good Manufacturing Practices (cGMP) knowledge
Excellent oral and written communication skills
Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
Skilled in performing NIST traceable temperature and humidity measurements with a variety of temperature/humidity measurement devices
Developed computer skills
Basic knowledge of refrigerator and freezer operation and temperature distribution patterns in such storage spaces
Must have strong ability to organize and manage multiple tasks in a fast-paced, but exciting environment
Working Conditions –
Environment – Office and warehouse
Physical Requirements – Must be able to use a computer for up to 8 hours per day; Must be able to stand for up to 8 hours per day; Must be able to work fully gowned- in laboratory coverall, hair cover, face-mask, and gloves for up to 8 hours per day; Must be able to walk for up to 4 hours per day; Must be able to lift up to 50 lbs; and must be able to work on 2º to 8ºC, –30º to -10ºC, –40º to -80ºC refrigerators/freezers for extended periods.