Work Schedule

Environmental Conditions

Job Description

COMPANY:                            Thermo Fisher Scientific Inc.

LOCATION:                            168 Third Avenue, Waltham, MA 02451

TITLE:                                    Engineer III, Validation

HOURS:                                  Monday to Friday, 8:00 am to 5:00 pm

DUTIES:                                 •           Draft validation protocols for method crossovers and performance qualification for QC instruments; 
•           Create instrument qualification packages using Kneat (e-validation software); 
•           Draft Unit Operational Procedures (UOPs), Qualification package (IQ/OQ/PQ) for the new QC lab instrument and equipment in Kneat and engineering change requests in Agile;
•           Review and compile the documentation for the QC lab instrument and equipment; 
•           Maintain, supervise and review documentation for the execution of IQ and OQ activities for vendors;
•           Perform statistical analysis using Minitab on historical data to support the site; 
•           Independently plan and execute experiments, data analysis and interpretation;
•           Collaborate with other teams to coordinate and resolve quality related issue; 
•           Maintain and troubleshoot laboratory equipment and instrumentation as needed; 
•           Support activities for lab expansions, scale-ups, and process improvement projects;
•           Produce and present original technical communication materials for internal and external stakeholders. 

TRAVEL:                                Up to 10% domestic or international travel required. Can work remotely or

telecommute.

REQUIREMENTS:                  MINIMUM Education Requirement:
•           Master’s degree, or foreign equivalent, in Industrial Engineering, Mechanical Engineering or a related field of study.

MINIMUM Experience Requirement: 
•           3 years of experience in instrument qualification, software validation or related experience.
 

Alternative Education and Experience Requirement: 
•           Bachelor’s degree, or foreign equivalent in Industrial Engineering, Mechanical Engineering, or a related field of study plus 5 years of experience in instrument qualification, software validation or related experience.  

Required knowledge or experience with: 

•           Minitab, Kneat and Agile; 
•           SPC, t-tests, ANOVA using Statistical data analysis (Minitab, JMP) for qualification and method transfer activities for QC Method; 
•           Instrumental analysis including analytical HPLC, spectroscopy, FTIR and Particle size; 
•           Manufacturing Practices (cGMP), 21 CFR Part 11 and ISO 13485 compliance requirements;
•           Continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.

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