Job title - Engineer ll, Upstream Manufacturing
Work Location - Cranbury NJ
Job Summary:
The primary responsibility of this role will be to support and deliver on process and equipment operation activities during manufacturing operations. As a MFG Engineer II, you will be expected to be a key operator in all Upstream process and support on upstream equipment from engineering perspective. Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP.
Responsibilities:
- Perform all core production tasks in the areas of upstream 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 upstream tech. transfer documents generated by MSAT and PD. Write, 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.
- Support cGMP manufacturing from process engineering perspectives, with responsibilities of troubleshooting process equipment, deviation investigation, CAPA implementation.
- Communicate and coordinate with ENG on equipment installation, start-up, operation and troubleshooting. Work with cross functional teams to facilitate the development and validation of Upstream Manufacturing.
- Support the implementation of new technologies, automation systems, and digital solutions to enhance the organization's efficiency, productivity, and innovation.
- Communicate and coordinate with ENG or other department about MFG upstream equipment maintenance system development, including spare parts inventory, calibration and preventive maintenance program, and continuous validation requirements.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Lead.
- 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.
Qualifications:
- Master’s or bachelor’s degree in biology, Chemistry, Chemical/Pharmaceutical Engineering, or other related Science/Engineer major.
- Minimum 2-year large scale biologics manufacturing hands on experience or biologics process development hands on experience for Master degree;
- Minimum 4-year large scale biologics manufacturing hands on experience or biologics process development hands on experience for Bachelor’s degree.
- Basic knowledge of regulatory GMP requirement for production of biopharmaceutical Drug Substance.
- Experience in CRDMO company would be a plus.
- Good communication skills, good multi-tasking ability, fast learning and competent for fast-pace work environment.
- Strong awareness of teamwork with an optimistic work attitude.
- Willing to travel as required internationally to fulfil the responsibilities of the position.
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.
WuXi Biologics is 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