Principal Engineer l, Upstream Manufacturing

WuXi Biologics Group; Northern (KY); Hybrid; USD 150,000 - 190,000; Full time

Job summary

WuXi Biologics Cranbury is seeking a Principal Engineer to lead a high‑performing upstream manufacturing team in a GMP environment. You will develop staff, drive KPI delivery, and ensure GDP/regulatory compliance across shift operations.

Responsibilities include cross‑functional leadership, process optimization, troubleshooting, and ensuring quality systems readiness for new product introductions while maintaining a strong safety culture.

Qualifications

• BS with 8+ years or MS with 6+ years in biopharmaceutical upstream manufacturing.
• Proven leadership of manufacturing teams and staff development.
• Deep knowledge of cGMP, safety and environmental regulations in biotech.

Responsibilities

• Lead a manufacturing team in GMP upstream operations.
• Drive continuous improvement and operational excellence.
• Ensure compliance with GMP, GDP and regulatory requirements.
• Coach and develop staff; manage cross-shift collaboration.
• Review documentation and support change controls as needed.

Skills

Team Leadership

Cross-functional Leadership

Regulatory Compliance

GDP Knowledge

KPI Delivery

Continuous Improvement

GMP Knowledge

Troubleshooting

Education

Bachelor’s degree in biopharmaceutical manufacturing

Master’s degree in biopharmaceutical manufacturing

Tools

DeltaV

AVEVA

Unicorn

LIMS

SAP

TrackWise

Job description

Principal Engineer l, Upstream Manufacturing

United States Posted 2026-01-09

Job Title - Principal Engineer l, Upstream Manufacturing

Work Location - Cranbury NJ

Job Summary

Reporting to the Manufacturing Director in MFG 18, the Principal Engineer is responsible for leading a team of highly trained professionals in the manufacture of biological products in adherence to the highest standards of quality and regulatory compliance. Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP. 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

• Key member of Manufacturing leadership team for WuXi Biologics Cranbury. Will play an important role in the execution of the business plans, ensuring cross functional collaboration and leadership execution.
• Develop and drive team performance, training, communication, delivery of objectives, direction, goals, and performance management.
• Develop, motivate, coach highly functioning manufacturing team.
• Oversee the day-to-day operation of the GMP production, training, communications, assignment and prioritization of work, delivery of objectives, and performance management.
• Ensures that the plant and equipment is operating in a compliant manner and that all activities are conducted to meet GMP regulations, site and corporate quality standards and any additional regulatory requirements as required.
• Provide instruction, training, guidance, and technical support to the shift team during MFG operations.
• Lead the deviation investigation or quality issues and escalate issues promptly.
• Lead change controls and emergency change controls where required.
• Makes informed technical decisions where appropriate and escalates issues promptly.
• Lead cross-functionally and cross-shifts to resolve issues and drive improvements.
• Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products.
• Review and approve of area documents, SOPs, Batch Records, Logbooks and On-The-Job Trainings.
• Drive continuous improvement and operational excellence within the manufacturing process.
• Oversees the review of completed documentation and comment resolution.
• Where necessary assist in Facility and Equipment start up and Validation activities.
• Supports technical transfer activities.
• Flexibility to take on additional tasks and responsibilities at the discretion of the Manufacturing Director.
• Will act as a role model for the manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture Qualificiacatoins
• BS with 8+ years or MS with 6+ years in biopharmaceutical manufacturing with extensive experience in Upstream processing Extensive experience in leading teams, supporting the continued development of employees, motivating and engaging them to achieve their potential.
• Expert experience in dealing with and resolving employee grievances and maintaining a positive and progressive work environment/culture.
• Comprehensive knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry
• Experience of operating automated control systems such as Delta V, AVEVA, Unicorn or similar systems is desired.
• Experience of LIMS, SAP, Trackwise etc. is an advantage.
• In-depth knowledge of relevant cGMP, safety and environmental regulations.
• Expert knowledge and experience of the manufacturing equipment and associated processes.
• Excellent knowledge of the documentation standards and protocols in a pharmaceutical/biopharma manufacturing environment.
• Strong leadership with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
• Excellent verbal and written communication and presentation skills.
• Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
• Ability to work on own initiative and be proactive.
• Results oriented, with the ability to manage multiple priorities in a short period of time.
• Excellent organisational and planning skills and strong attention to detail

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

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 based on disability.