Abzena · 9 hours ago
MSAT Engineer I
San Diego, CA
Full-time
Onsite
New Grad, Entry Level
$110K/yr - $125K/yrAbzena is a company specializing in developing biologics and bioconjugates, committed to delivering high-quality products and services. The MSAT Engineer I will provide technical leadership and support technology transfer activities while ensuring compliance with regulatory standards and supporting production issue resolution.
BiopharmaBiotechnologyLife SciencePharmaceutical
Responsibilities
Provide support for production issue resolution and investigation with data analysis, ensuring reliable solutions, safe execution, and regulatory compliance
Provide in-person and real-time manufacturing production support required for project success
Adhere to all GDP, GLP, and cGMP requirements as required while fulfilling duties, responsibilities, and tasks
Demonstrate ownership of the equipment and process you support by being flexible, proactive, and involved. Serve as a responsible engineer to process by possessing a deep knowledge of equipment and unit operation design characteristics and capabilities
Demonstrates technical proficiency, scientific creativity, leadership, and collaboration with others
Ability to manage multiple tasks and projects effectively with support to meet timelines
Accept temporary responsibilities outside of initial job description
Provide training and guidance on process and technical operations to manufacturing personnel and MSAT, with a focus on engineering principles
Collaborate in cross functional activities with development and manufacturing personnel, both internal and external, to support process scale-up, technology transfer, process characterization, and process validation. Provide support to junior engineers in external discussions
Strong interpersonal and presentation skills with the ability to collaborate effectively, influence outcomes, and drive decisions across diverse teams and stakeholders
Support Technology Transfer into cGMP Manufacturing from internal or external process development teams for Downstream operations based on area of expertise
Plan, lead, and/ or implement multiple smaller projects at the same time with support
Initiate and recommend improvements in process and equipment operation with support, based on sound engineering and scientific knowledge, toward increasing process robustness, efficiency, and productivity
Implement new equipment and process technologies in manufacturing area with support and train manufacturing personnel on these technologies
Write, revise, review, and otherwise support the document life cycle for master batch records, BOMs, Specifications, SOPs, Tech Transfer Documents, PFDs, and P&IDs
Analyze, manage, and drive to completion risk assessments and facility fit for process transfer, scale up, and new material introduction
Maintain a strong working knowledge of cGMP raw materials, consumables, assemblies, in-process materials, designs, and part numbers to complete detailed cGMP records
Qualification
Required
Deep knowledge and understanding of cGMPs and how they apply to duties and responsibilities
Knowledge and skill with aseptic technique required: BSC Operations, and aseptic processing, including welding/sealing and/or single use sterile connectors
Large molecule biologics such as: mAb (IgG1, IgG4), fab, IgM, Fusion, VLP, or other
Strong working knowledge of Tangential Flow Filtration (UF/DF) and Harvest Operations is preferred
Understanding of Viral Clearance Validation
Understanding of separations, Clearance, and Purification Systems, such as: Disk Stack Centrifugation, Depth Filtration Chromatography (Affinity, Ion Exchange, HIC, SEC, Mixed Mode), particularly using AKTA systems, Viral Inactivation, Viral Filtration, Tangential Flow Filtration (UF/DF)
Expertise in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook, Teams, Visio, Smartsheet etc
Functions and graphing within Microsoft Excel required
Experience with semi/fully automated manufacturing equipment
Should understand basic statistical methods and their application in tech transfer and product lifecycle
Preferred
Strong working knowledge of Tangential Flow Filtration (UF/DF) and Harvest Operations
Experience with SCADA systems
Company
Abzena
Abzena is a biotechnology company that offers biologic and ADC products from concept to clinic.
Founded in 2001
501-1000 employees
H1B Sponsorship
Abzena has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$139.44MKey Investors
Biospring PartnersProVen VCT
2022-03-31Private Equity· $65M
2020-07-28Private Equity· $10M
2018-08-16Acquired
Leadership Team
Geoffrey Glass
Chief Executive Officer
Daniel Giroux
Vice President, Development
Recent News
Genetic Engineering News
2025-11-08
2025-10-24
Company data provided by crunchbase