Process Engineer - Fermentation , Small Molecule Drug Substance
Job Description
Job Description
The Spear Group Full-Time Opportunity with Corporate Benefits
Position: Process Engineer (Drug Substance - Fermentation & Small Molecule) Min 6 years with this type of drug substance processing
Location: Carteret, NJ
Position Summary:
The Spear Group has an exciting career opportunity for an experienced and knowledgeable Process Engineer dealing with small molecule drug substances and fermentation processes. The ideal candidate has a minimum of 6 years' experience with fermentation process engineering and OEB experience, dispense, isolator experience, solid handling API experience, small molecule experience, and OSD experience. This position supports our big pharma/biopharma partner in the Carteret, NJ area with agile and progressive processing pipeline operations. This position requires an experienced Process Engineer with a minimum of 6 years’ experience using fermentation processing methods.
Key Responsibilities:
- Demonstrates a strong understanding of GMPs and provides Process Engineering and Project Engineering support End to End in highly regulated pharmaceutical facilities. Candidates should have demonstrated experience with drug substance / bioprocessing manufacturing processes.
- Apply biopharma innovative enthusiasm and bioprocessing technical skills as a member of a multidisciplinary team.
- Design and Startup qualification.
- Design, startup and qualification of Fermenters, Bioreactors, Downstream purification.
- Challenge traditional practices to make way for innovative/creative solutions. Process improvement focus.
- Support the manufacturing of product engineering and validation lots.
- Support technical investigations.
- Support commissioning and qualification of new equipment.
- Support regulatory submissions.
- Drive process/business system improvements.
Required Experience and Education:
- Bachelor of Science Degree in engineering – chemical engineering, biomedical engineering, biological engineering, biochemical or biomolecular engineering, or any related engineering major.
- 6 + years of experience with drug substance process engineering involving fermentation,and OEB experience, dispense experience, isolator experience, solid handling API experience, small molecule experience, and OSD experience. REQUIRED.
- Experience with design and startup qualification.
- Experience with the design, startup and qualification of Fermenters, Bioreactors, Downstream purification.
- Experience with utilizing single use technology.
- Experience challenging traditional manufacturing practices to make way for innovative/creative solutions. Experience impacting process improvement.
- Experience supporting the manufacturing of product engineering and validation lots.
- Experience supporting technical investigations.
- Experience with the commissioning and qualification of new equipment.
- Experience supporting regulatory submissions.
- Experience with driving process/business system improvements.
- Extensive experience with GMP.
Compensation based on relevant experience
EQUAL OPPORTUNITY EMPLOYER
The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.