Process Engineer - Drug Substance - The Spear Group

Position: Process Engineer (Drug Substance)

Location: Carteret, NJ

Position 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. Further your bioprocessing career supporting our top-tier BioPharma client in the Carteret, NJ area. This position requires an experienced Process Engineer to make an impact from the design phase to start-up qualification.

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 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, mechanical engineering, biological engineering, biochemical or biomolecular engineering, or any related engineering major.
• 7-15 years of experience with drug substance process engineering.
• 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.