Process Engineer III

How will you make an impact?

We are searching for a Process Engineer3witheducation andexperience in biopharmaceutical processingor a related field. This member of our team provides technological input in thedevelopment, validation,andtransfer of manufacturing processes.AProcessEngineer3routinely supportstheProcess Engineering team astechnical ownersof customerprograms inamanufacturingenvironmentandwillbe highly involvedand act as a subject matter expertindefiningand shapingThermo Fisher Scientific’s own technology programs.This role willcollaborateinternally withsupervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Developmentand with the clientasa ProcessEngineer program lead. These activities areconductedin projects and involve teamwork with experts across functional groups to ensure project success.

What will you do?

• Draft,reviewand approveStandard Operation Procedures, and Job Aidsand consult internally to ensure scientifically sound and robust procedures.

• Collaboratewiththeprocessdevelopment todevelopstandardized methodologiesand learn/explorenew methodologiesfor conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.

• Contribute to Internal and Customer meetings based upon sound evidenceguided byminimalsupervision.

• Manages internal projectsand tasksandleadclientprojects andmanagetimelines withminimalsupport from supervision.

• Activelyidentifyerror proofing opportunities andinitiateanddrive engineering initiatives to improve practices and procedureswith minimal supervision.

• Provide scientificexpertisefor GMP deviationsby assessing,reviewingand approvingthe impact of major deviations on both the product quality and the validation of the process. 

• Lead changes to equipment and processdesign, proactively and with minimal supervision.

• Draft,reviewandapproveManufacturing Batch Records,PerformanceQualifications,ProcessValidation protocols, process flow diagrams, automation methods,andBill of Materials,ensuring the process is technicallyaccurateanddesigned for Manufacturing.

• Draft, review, and approveProcess control documents, campaign summaryreportandprocessvalidation reports 

• Reviews,analyzesand trends process data withoutsupervision

• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.

• Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.

• Support our MSAT team withadditionaltasks to improve the site, ensure patient safety, and deliverforour customers.

• Provides development and trainingforProcess Engineers/Scientists.

How will you get here?

Education

• Bachelor’s degreerequiredin a scientific field, preferably an engineering field. 

• 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree in a scientific field +3years' experience or Ph.D.).

Experience

• 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree in a scientific field + 3 years' experience or Ph.D.). 

• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment.

• Ability to self-motivate, prioritize work and time.

• Demonstrates a foundation in general scientific practices, principles,and concepts.

• Writesandcommunicateseffectively.

• Ability to work both independently and as part of a team.

• Knowledge of current Good Manufacturing Practices and US/EU regulations.

• Intermediateknowledge of statistical methods used for Pharmaceutical Process Analysis is a plus. 

• Proficient in Microsoft Word and Excel.

• Ability to stand for prolonged periods of time and gown into manufacturing areas.

Relocation Benefits

This position does not offer relocation benefits.

Our Mission is to enable our customers to make the world healthier, cleaner,and safer. Watch as our colleagues explain5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity,Innovation,and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminateon the basis ofrace, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status,disabilityor any other legally protected status.

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