Principal Engineer

Job Summary

As Principal Engineer I, you will be expected to be a subject matter expert in biologics processing and in-process equipment. Detailed knowledge of the process will be vital to ensure optimum operations, with a high level of understanding of GDP. You will lead a team responsible for hands‑on manufacturing processing and technical support, support technology transfers and troubleshoot during GMP manufacturing, communicate project status to internal teams and clients, and lead quality events that occur during GMP production.

The Principal Engineer will develop the team to consistently deliver on the KPIs and meet customer expectations.

• Serve as a SME to support cGMP hands‑on manufacturing activities, providing instruction, training, guidance and technical support to the MFG team.
• 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 input and support on equipment installation, start‑up, operation and troubleshooting to support new equipment launches.
• Lead the implementation of new technologies, automation systems, and digital solutions to enhance efficiency, productivity, and innovation.
• Develop and drive team performance, training, communication, delivery of objectives, and performance management.
• Support manufacturing process equipment maintenance system development, including spare parts inventory, calibration, preventive maintenance, and continuous validation requirements.
• Perform engineering assessments, root cause analyses, and troubleshooting to resolve technical issues and improve process performance.
• Lead change controls and emergency change controls where required.
• Makes informed technical decisions and escalates issues promptly.
• Key member of the manufacturing execution team for WuXi Biologics USA, ensuring cross‑functional collaboration.
• Perform core production tasks and all ancillary tasks related to production activities.
• Conduct all activities in accordance with Company policies & SOPs, WuXi values, and global regulatory guidelines (e.g., cGMP/cGLP/cGCP).
• Collaborate with production shifts for continuous process improvement, reducing production cost and enhancing productivity.
• Review technical transfer documents generated by MSAT and PD.
• Draft, review, and revise GMP documents including BOM/SOP/OJT/M /Batch report/URS/FAT/SAT.
• Participate in drafting and reviewing template or project batch records to ensure smooth on‑floor activities.
• Be flexible to take on additional tasks and responsibilities at the discretion of the MFG Supervisor.
• Shift working may be required; weekend and holiday work may be necessary.
• Ongoing overtime and standing for long periods may be required.
• Act as a role model for manufacturing and the wider organization, adhering to WuXi corporate core values and PROUD culture.

• Technical expertise in bioprocessing/biotechnology and/or biologics process development.
• Master’s or bachelor’s degree in Biology, Chemistry, Chemical/Pharmaceutical Engineering, or related field.
• Minimum 5 years of large‑scale biologics manufacturing or process development hands‑on experience.
• Extensive knowledge of regulatory GMP requirements for biopharmaceutical drug substance production.
• Experience in a CRDMO company is a plus.
• Knowledge of current Good Manufacturing Practices (GMP).
• Knowledge of biotech manufacturing processes and translation into documentation such as batch records and SOPs.
• Excellent communication, interpersonal and presentation skills.
• Fast learning and ability to work in a fast‑paced environment.
• Strong awareness of teamwork and optimistic work attitude.
• Collaborative and inclusive work approach.
• Excellent problem‑solving and troubleshooting skills.
• Flexible approach and positive attitude fit for team dynamics.
• Engagement cross‑functionally with a site‑based team.
• Autonomous and self‑starter who uses initiative to drive actions forward.
• Strong ethics in adhering to company procedures, regulatory standards, and customer expectations.
• Willingness to travel internationally as required.
• Must be willing to work varying shifts to accommodate client requirements.
• When absent from the site, duties will be delegated to:
  • Job Title:
    
    MFG Engineer
  • Job Title:
    
    MFG Supervisor
  • Job Title:
    
    MFG Manager/Senior Manager

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. All qualified applicants for employment will be given consideration without regard to identical characteristics, and employment decisions will be based only upon qualifications and skills.