WuXi Biologics · 5 hours ago
Principal Engineer I
Cranbury, NJ
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expWuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics. As Principal Engineer I, you will be responsible for leading a team in hands-on manufacturing processing, providing technical support, and ensuring compliance with GMP standards while fostering a culture of continuous learning and development.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Serve as a SME to support cGMP hands-on manufacturing activities, providing instruction, training, guidance and technical support to the MFG team, fostering a culture of continuous learning and professional development
Troubleshoot process equipment, and lead deviation investigation and CAPA implementation
Collaborate with internal stakeholders and external partners to support technology transfer, scale-up, and production activities for downstream MFG processes. Provide feedback during technology transfer meetings on technical or operational challenges
Provide input and support on equipment installation, start-up, operation and troubleshooting to support the introduction of new equipment. Work with cross functional teams to facilitate the development and validation
Lead the implementation of new technologies, automation systems, and digital solutions to enhance the organization's efficiency, productivity, and innovation
Develop and drive team performance, training, communication, delivery of objectives, direction, goals, and performance management
Support manufacturing process equipment maintenance system development, including spare parts inventory, calibration and preventive maintenance program, and continuous validation requirements
Perform engineering assessments, root cause analyses, and troubleshooting to resolve technical issues, improve process performance, and ensure product quality and compliance
Lead change controls and emergency change controls where required
Makes informed technical decisions where appropriate and escalates issues promptly
Key member of manufacturing execution team for WuXi Biologics USA. Will play an important role in the execution of the business plans, ensuring cross functional collaboration
Perform all core production tasks and all ancillary tasks that related to production activities
Conducts all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, and controlled documents., etc
Collaborate with production shifts for continuous process improvement for both on floor operations and manufacturing process, reducing the production cost and enhance productivity
Review technical transfer documents generated by MSAT and PD
Draft, Review and Revision of GMP documents including but not limited to BOM/SOP/OJT/MBR/Batch report/URS/FAT/SAT
Participate in the drafting and reviewing of template or project batch records to ensure smooth on-floor activities. Provide insight on new practices or new equipment on project meetings if needed
Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Supervisor
Shift working may be required. The shift pattern may be varied according to business requirements and will typically require weekend work
Will be flexible to take overtime work and may work during holidays
May require standing for long periods of time
Will act as a role model for the manufacturing function and the wider organization in adherence to the WuXi corporate core values and PROUD culture
Qualification
Required
Technical expertise of bioprocessing/biotechnology and/or biologics process development
Master's or bachelor's degree in Biology, Chemistry, Chemical/Pharmaceutical Engineering, or other related Science/Engineer major
Minimum 5 years large-scale biologics manufacturing hands-on experience or biologics process development hands-on experience
Extensive knowledge of regulatory GMP requirement for production of biopharmaceutical Drug Substance
Knowledge of current Good Manufacturing Practices (GMP)
Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs
Excellent communication, interpersonal and presentation skills
Fast learning and competent for fast-pace work environment
Strong awareness of teamwork with an optimistic work attitude
Collaborative and inclusive approach to work and your colleagues
Excellent problem solving and troubleshooting skills
Flexible approach to work and a positive attitude will be a good fit within the team dynamic
Engage cross functionally in conjunction with a site-based team
Autonomous and a self-starter who will use their initiative to drive actions forward
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations
Willing to travel as required internationally to fulfil the responsibilities of the position
Must be willing to work varying shifts to accommodate client requirements
Preferred
Experience in CRDMO company would be a plus
Company
WuXi Biologics
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
10001+ employees
H1B Sponsorship
WuXi Biologics 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
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-06-13IPO
2017-01-01Series Unknown
Leadership Team
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
Recent News
South China Morning Post
2026-01-23
South China Morning Post
2026-01-19
Company data provided by crunchbase