WuXi Biologics · 1 week ago
Principal Engineer l, Upstream Manufacturing
Cranbury, NJ
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expWuXi Biologics is a leading biopharmaceutical company, and they are seeking a Principal Engineer to lead a team in the manufacture of biological products. The role involves ensuring quality and regulatory compliance while developing team performance and overseeing day-to-day operations.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
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
Preferred
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
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
2026-01-17
Company data provided by crunchbase