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Job Details

Skills

Science
Quality Assurance
Teamwork
Collaboration
Process Engineering
Cell Culture
Harvest
Management
Process Modeling
Process Flow
Bill Of Materials
Process Control
Reporting
Supervision
Training
GMP
Policies and Procedures
SAFE
Pharmaceutics
Process Analysis
Microsoft Word
Microsoft Excel
Manufacturing

Summary

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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 3 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 Process Engineer 3 routinely supports the Process Engineering team as technical owners of customer programs in a manufacturing environment and will be highly involved and act as a subject matter expert 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 with the client as a Process Engineer program lead. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.

What will you do?

Draft, review and approve Standard Operation Procedures, and Job Aids and consult internally to ensure scientifically sound and robust procedures.
Collaborate with the process development to develop standardized methodologies and learn/explore new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
Contribute to Internal and Customer meetings based upon sound evidence guided by minimal supervision.
Manages internal projects and tasks and lead client projects and manage timelines with minimal support from supervision.
Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures with minimal supervision.
Provide scientific expertise for GMP deviations by assessing, reviewing and approving the impact of major deviations on both the product quality and the validation of the process.
Lead changes to equipment and process design, proactively and with minimal supervision.
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, review, and approve Process control documents, campaign summary report and process validation reports
Reviews, analyzes and trends process data without supervision
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.
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 field.
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.).

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.
Writes and communicates effectively.
Ability to work both independently and as part of a team.
Knowledge of current Good Manufacturing Practices and EU regulations.
Intermediate 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10286239
Position Id: f8a08c77a5760716a419ecda994eea4
Posted 2 days ago

CMC Regulatory Affairs - Small Molecule

Remote

•

Today

Job Title: CMC Regulatory Affairs Specialist/Manager Small Molecules Location: Remote Experience: 10+ Years Job Summary We are seeking an experienced CMC Regulatory Affairs professional with expertise in small molecule drug development to support global regulatory submissions and lifecycle management activities. The candidate will be responsible for preparing, reviewing, and managing Chemistry, Manufacturing, and Controls (CMC) regulatory documentation for investigational and marketed products.

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Contract, Third Party

Depends on Experience

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Process Engineer III, Manufacturing Sciences

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Process Engineer III, Manufacturing Sciences

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