Principal Engineer Cell & Gene Therapy (Biomanufacturing) - Fresenius Medical Care : Job Details

Job Summary

Experienced biomanufacturing engineering position, under minimal supervision participates in designing, building, and maintaining 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 person 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.* 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.This role will be Remote.* Base salary range: $100,000-120,000.* Position is eligible to participate in an annual bonus plan with a target of 8% 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. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Supports in tech transfer, process development, optimization, and scale-up activities. Work closely with 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.Understands 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 proceduresInform future manufacturing strategies and product roadmapsDevelop 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.Stay up to date with industry trends and best practices in biomanufacturing and cell therapy production.

Requirements

* Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related field (Master's or PhD preferred).* Minimum of 5 years of experience in biomanufacturing, protein conjugation, or pharmaceutical production.* Strong understanding of bioprocessing 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.* 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.