Process Development Engineer I

Process Development Engineer I at Redbock - an NES Fircroft company Process Development Engineer I at Redbock - an NES Fircroft company in West Valley City, Utah Posted in 2 days ago.

Type:

full-time

Job Description:

Our client, an innovative biotechnology company focused on developing therapies for neurodegenerative diseases, is seeking a Contract Manufacturing Science and Technology (MSAT) Engineer to support cell culture operations within their early-stage Technical Operations organization. This individual will contribute to lab-scale process execution, technology transfer activities, data analysis, and technical documentation in support of advancing biopharmaceutical manufacturing processes. This is an excellent opportunity for an early-career engineer to gain hands-on experience in MSAT, process scale-up, and technology transfer within a collaborative and fast-paced biotechnology environment. Key Responsibilities Responsible for cell culture operations in the MSAT lab. This includes, but is not limited to, actual lab operations and any associated lab testing. Perform routine monitoring, data collection, analysis, and documentation of process runs, maintaining accurate and compliant lab notebooks and/or electronic records. Assist with lab management including but not limited to sample and inventory management, processing incoming RMs and consumables as well as outgoing samples and/or GLP material. Support and perform drafting and revising of technical documentation (batch records, SOPs, protocols, recipes, reports, etc.). Prepare technical summaries, reports, and presentations to effectively communicate findings to cross-functional teams as needed. Ensure compliance with lab safety protocols, GxP requirements, and applicable environmental guidelines. Conduct all activities in alignment with company policies, Standard Operating Procedures, and global regulatory guidelines, ensuring adherence to quality assurance standards. Remain up to date on all assigned training and ensure completion of any training required for GxP activities prior to executing those activities. Qualifications Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biotechnology, or a related scientific discipline. 0 to 2+ years of relevant engineering or biopharmaceutical industry experience. Strong organizational skills with attention to detail and documentation accuracy. Excellent written and verbal communication skills. Ability to work effectively in a collaborative, fast-paced environment. Demonstrated ability to adapt to changing priorities and business needs. Must be able to work weekends occasionally. Must be able to travel up to 10%. Preferred Qualifications Experience within the biopharmaceutical industry, particularly supporting protein therapeutics. Hands-on experience with lab or pilot-scale bioprocessing technologies, including mammalian cell culture and aseptic techniques. Experience operating laboratory analytical equipment such as HPLC and other process analytical tools. Familiarity with FDA cGMP/GxP regulations applicable to clinical biopharmaceutical manufacturing. Experience supporting GxP documentation systems, procedures, and compliance activities.