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Process Engineer II
ThermoFisher Scientific • Saint Louis, MO 63112 • Posted 4 days ago
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In-person • Full-time • Mid Level
Job Highlights
Using AI ⚡ to summarize the original job post
The Process Engineer II at ThermoFisher Scientific is responsible for providing technological input in the development, validation, and transfer of manufacturing processes. This role involves supporting the PE team as technical owners of customer programs in a manufacturing environment, collaborating with various departments, and managing internal and client projects. The position requires a Bachelor's degree in a scientific field, preferably engineering, with 2+ years of experience in GMP regulated Biologics/Pharma Industry, or equivalent.
Responsibilities
- Draft Standard Operation Procedures, and Job Aids.
- Collaborate with the process development to assess standardized methodologies and learn new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
- Support Internal and Customer meetings based upon sound evidence guided by supervision.
- Manage internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.
- Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.
- Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.
- Lead changes to equipment and process design.
- Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.
- Draft Process control documents, campaign summary report and process validation reports
- Reviews, analyzes and trends process data with minimal direction
- Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
- Solve 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.
- Provides development and training for Process Engineers/Scientists.
Qualifications
Required
- Bachelor's degree in a scientific field, preferably an engineering field with 2+ years experience.
- 2+ 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 balanced workplace environment.
- Ability to self-motivate, prioritize work and time.
- Demonstrates a foundation in general scientific practices, principles, and concepts.
- Writes and communicates efficiently.
- Ability to work both independently and as part of a team.
- Knowledge of current Good Manufacturing Practices and US/EU regulations.
Preferred
- Master's degree in a scientific field, preferably an engineering field.
- Novice knowledge of statistical methods used for Pharmaceutical Process Analysis.
- Proficient in Microsoft Word and Excel.
- Ability to stand for prolonged periods of time and gown into manufacturing areas.
About ThermoFisher Scientific
Thermo Fisher Scientific is a multinational biotechnology company that provides a wide range of products and services in the scientific research and diagnostics industry. They offer scientific instruments, laboratory equipment, diagnostic testing solutions, and more to customers worldwide in industries such as pharmaceuticals, biotechnology, healthcare, academia, and environmental research. Thermo Fisher Scientific is known for its high-quality products, robust R&D capabilities, and strategic acquisitions that have solidified its position as a leader in the market.
Full Job Description
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**How will you make an impact?**
We are searching for a Process Engineer II with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes. A person in this role routinely supports the PE team as technical owners of customer programs in a manufacturing environment and will assist in defining and shaping Thermo Fisher Scientific's own technology programs. This role will collaborate internally with supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and occasionally with the client. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.
**Standard Job Duties**
+ Draft Standard Operation Procedures, and Job Aids.
+ Collaborate with the process development to assess standardized methodologies and learn new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
+ Support Internal and Customer meetings based upon sound evidence guided by supervision.
+ Manage internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.
+ Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.
+ Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.
+ Lead changes to equipment and process design.
+ Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.
+ Draft Process control documents, campaign summary report and process validation reports
+ Reviews, analyzes and trends process data with minimal direction
+ Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
+ Solve 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.
+ Provides development and training for Process Engineers/Scientists.
**How will you get here?**
**Education **
+ Bachelor's degree required in a scientific field, preferably an engineering fieldwith 2+ years experience.
+ Master's degree in a scientific field, preferably an engineering field.
**Experience **
+ 2+ 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 balanced workplace environment.
+ Ability to self-motivate, prioritize work and time.
+ Demonstrates a foundation in general scientific practices, principles, and concepts.
+ Writes and communicates efficiently.
+ Ability to work both independently and as part of a team.
+ Knowledge of current Good Manufacturing Practices and US/EU regulations.
+ Novice 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 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 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.com ** **
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.
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.
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**How will you make an impact?**
We are searching for a Process Engineer II with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes. A person in this role routinely supports the PE team as technical owners of customer programs in a manufacturing environment and will assist in defining and shaping Thermo Fisher Scientific's own technology programs. This role will collaborate internally with supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and occasionally with the client. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.
**Standard Job Duties**
+ Draft Standard Operation Procedures, and Job Aids.
+ Collaborate with the process development to assess standardized methodologies and learn new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
+ Support Internal and Customer meetings based upon sound evidence guided by supervision.
+ Manage internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.
+ Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.
+ Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.
+ Lead changes to equipment and process design.
+ Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.
+ Draft Process control documents, campaign summary report and process validation reports
+ Reviews, analyzes and trends process data with minimal direction
+ Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
+ Solve 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.
+ Provides development and training for Process Engineers/Scientists.
**How will you get here?**
**Education **
+ Bachelor's degree required in a scientific field, preferably an engineering fieldwith 2+ years experience.
+ Master's degree in a scientific field, preferably an engineering field.
**Experience **
+ 2+ 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 balanced workplace environment.
+ Ability to self-motivate, prioritize work and time.
+ Demonstrates a foundation in general scientific practices, principles, and concepts.
+ Writes and communicates efficiently.
+ Ability to work both independently and as part of a team.
+ Knowledge of current Good Manufacturing Practices and US/EU regulations.
+ Novice 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 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 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.com ** **
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.
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.
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