Sr Principal Engineer (Biomanufacturing)

Fresenius Kabi USA, LLC
$130,000.00 - $140,000.00 / yr
life insurance, 401(k)
United States, Illinois, Lake Zurich
3 Corporate Drive (Show on map)
Aug 19, 2025
Job Summary Highly experienced biomanufacturing engineering position, under minimal or no supervision guides the design, build, and maintenance processes to test, validate, and verify engineering projects related to medical technology. This role will focus on overseeing the technical setup and execution at contract biomanufacturing sites, with a strong emphasis on antibody/protein production (CHO and E. coli), protein conjugation, and purification processes. This position will contribute to technology transfer, process development, and scale-up activities, while ensuring alignment with regulatory and quality standards. This position requires cross-functional collaboration with scientific, regulatory, quality, and supply chain teams, and offers the opportunity to shape future manufacturing strategies and product roadmaps. May assist and mentor experienced engineers. Salary Range: $130,000 - $140,000 per year Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future. Responsibilities Guides tech transfer, process development, optimization, and scale-up activities. Provide direction to contract manufacturing organizations (CMOs) to ensure technical and operational alignment with company standards. Plans, designs, executes, documents, and analyzes a regimen of tests to evaluate, verify and/or validate a system. Provide knowledge in biomanufacturing processes, particularly antibody/protein production (CHO and e coli), protein conjugation, and purification techniques. Interface with scientific/laboratory teams to develop functional tests, experimental protocols, and new target evaluations. Assesses risks and creates test plans around risk priorities; analyzes results, states conclusions, and assesses residual risks after tests are complete; in addition, assesses adequacy of support for conclusions by test results. Displays advanced understanding of regulations, to apply guidance and standards on design verification and design validation to test activities and work products; prepares documentation for compliance with standard operating procedures Inform future manufacturing strategies and product roadmaps Develops and review technical documentation, including standard operating procedures (SOPs), batch records, and validation protocols. Troubleshoot manufacturing challenges and support investigations into deviations or process failures. Collaborate cross-functionally with marketing, quality, regulatory, and supply chain teams to ensure seamless operations. Leads with industry trends and best practices in biomanufacturing and cell therapy production. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements * Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field (Master's or PhD preferred). * 8+ years of experience in biomanufacturing, protein conjugation, or pharmaceutical production. * Strong understanding of bioprocessing and cell processing techniques, including upstream and downstream operations. * Familiarity with cGMP, regulatory requirements (FDA, EMA), and quality assurance practices in biomanufacturing. * Hands-on experience working with contract manufacturing organizations (CMOs) is a plus. * Excellent problem-solving skills and ability to work in a fast-paced environment. * Demonstrates leadership abilities, strong communication and collaboration skills to effectively engage with internal and external stakeholders. * Prior experience in technology transfer and process validation preferred. * Prior knowledge of analytical methods for protein characterization preferred. * Prior involvement in regulatory inspections or audits preferred. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.