Job Opportunity

Job Opportunity

Principal Engineer I

Principal Engineer I

United States Posted 2026-01-27

Job Title – Principal Engineer I

Work Location - Cranbury NJ

WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies

Job Summary:

As Principle 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 process operations, as well as a high level of understanding of GDP. Mainly responsible for leading a team responsible for hands-on manufacturing processing and technical support, the inbumbent will also support project technology transfers and troubleshooting during GMP manufacturing. The candidate will be communicating with internal teams and clients on project status and be responsible to lead any quality events that occurred during GMP production. The Principal Engineer will be responsible for the development of the team to consistently deliver on the specific KPI’s and to meet with the expectations of our customers.

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

Qualifications:

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.
Experience in CRDMO company would be a plus.

Knowledge of current Good Manufacturing Practices (GMP)
Knowledge of biotech manufacturing processes and their translation into documentation such as batch records and SOPs

Behavioural Competencies :

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

Onerous requirements:

Willing to travel as required internationally to fulfil the responsibilities of the position.

Must be willing to work varying shifts to accommodate client requirements.
When absent from the site duties and responsibilities will be delegated to the following designates:
Job Title: MFG Engineer
Job Title: MFG Supervisor
Job Title: MFG Manager/Senior Manager

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs. 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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