Process Engineer

The Spear Group Full-Time Opportunity with Corporate BenefitsPosition: Process Engineer (Drug Substance - Fermentation & Single Use, min 5 years exp)Location: Carteret, NJPosition Summary:The Spear Group has an exciting career opportunity for an experienced and knowledgeable Process Engineer dealing with drug substance and fermentation processes utilizing some single use methods. This position supports our big pharmabiopharma partner in the Carteret, NJ area with agile and progressive processing pipeline operations. This position requires an experienced Process Engineer with a minimum of 5 years' experience using fermentation processing methods using single use bioreactors.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.Utilize single use technology.Challenge traditional practices to make way for innovativecreative 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 processbusiness 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.5-7 + years of experience with drug substance process engineering involving fermentation.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 innovativecreative 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 processbusiness system improvements.Extensive experience with pensation based on relevant experienceEQUAL OPPORTUNITY EMPLOYERThe 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.

Created: 2025-02-14