Sr. Process Engineer

Sr. Process Engineer Architecture & Engineering Fremont, CA, US Pay Rate Low: 55.00 | Pay Rate High: 60.00 Added - 28/10/2024 Apply for Job Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Senior Process Engineer to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference! Location: Fremont, CA Responsibilities: Oversee the transfer and implementation of internal and external contract manufacturing processes into our multi-product facility Serve as the technical lead for at-scale manufacturing of upstream and/or downstream processes, including bioreactor operations, cell culture, and bulk formulation Provide scientific and technological support during process transfers, product launches, and initial supply Collaborate with cross-functional teams and external clients to meet project timelines and quality requirements while identifying and mitigating risks Author and maintain technical documentation, including process descriptions, campaign performance summaries, and regulatory submissions (BLA filings) Design and develop data repositories for monitoring, analyzing, and reporting process trends to enhance efficiency and compliance Mentor and coach junior team members while leading continuous improvement initiatives Qualifications: Bachelor's Degree in Biochemical Engineering or related field 6+ years of professional experience in biopharmaceutical manufacturing or 10+ years of equivalent technical/design experience Strong understanding of biopharmaceutical manufacturing processes, including upstream and downstream operations Experience in project management, technical writing, and regulatory filings Knowledge of aseptic processing, buffer preparation, and GMP practices Excellent communication and teamwork skills, with the ability to work independently and in high-pressure environments Competency in MS Office programs and data visualization tools INDH #LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Created: 2024-10-31