Job DescriptionHow will you make an impact?We are searching for a Process Engineer with experience in biopharmaceutical processing. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes. The Process Engineer is the technical owner of customer programs in a manufacturing environment and will define and shape Thermo Fisher Scientific’s own technology programs. This role will collaborate with customers, supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, line management, and scientists in Process Development. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.What will you do?
Create detailed Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
Collaborate with the process development to develop standardized methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
Demonstrate initiative and an eagerness to learn new systems.
Participate in Internal and Customer meetings guided by supervision.
Lead projects and manage timelines with support from supervision as needed.
Actively drive engineering initiatives to improve practices and procedures.
Provide scientific input for GMP deviations.
Help devise and implement Corrective and Preventative Actions.
Lead changes to equipment and process design.
Draft Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, and Technical Reports, ensuring the process is technically accurate and designed for Manufacturing.
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 with additional tasks to improve the site, ensure patient safety, and deliver for our customers.
How will you get here?Education
Bachelor’s degree required in a scientific field, preferably an engineering field.
Experience
1 years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience.
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.
Writes and communicates effectively.
Ability to work both independently and as part of a team.
Knowledge of current Good Manufacturing Practices and US/EU regulations.
Knowledge 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 BenefitsThis 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 explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.Apply today! http://jobs.thermofisher.comThermo 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.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodation in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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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.