Senior Process Engineer Ll

Senior Process Engineer ll

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 jobopportunities 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

We seek a talented and experienced Senior Process Engineer to join our dynamic team of engineers. The Senior Engineer will be designing, developing, and implementing engineering solutions to support our biotechnology research, development, and manufacturing operations. The ideal candidate will have strong engineering principles and a passion for advancing biotechnological solutions.

The Sr. Process Engineer will be responsible for implementing biologics manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process templates, E-Systems deployment, inspection readiness, and training. The Sr. Process Engineer will support product lifecycle management, including commercialization and evolution of biological products, and day-to-day operations to ensure a reliable and high-quality supply. The role collaborates across all functional areas to ensure project advancement, rapid and best-in-class execution, and communication of challenges/opportunities. This position is responsible for designing, supporting, and troubleshooting bioprocessing equipment. The person in this role is expected to have technical expertise in bioprocess equipment manufacturing systems and good knowledge of cGMP operation. They will work closely with function teams and lead the execution of equipment design, validation/life cycle management, and day-to-day operations support from a Process Engineering perspective.

Requirements:

• Lead engineering projects to design, develop, and optimize processes, equipment, and facilities for biotechnology research, development, and manufacturing.
• Collaborate with cross-functional teams, including scientists, researchers, manufacturing specialists, and regulatory experts, to define project requirements, objectives, and timelines.
• Design and execute experiments, feasibility studies, and risk assessments to evaluate novel engineering concepts, technologies, and methodologies.
• Develop detailed engineering specifications, drawings, and documentation for equipment, instrumentation, and facility modifications in compliance with regulatory requirements and industry standards.
• Manage engineering vendors, contractors, and external partners to ensure the successful execution of engineering projects within budget and schedule constraints.
• Perform engineering assessments, root cause analyses, and troubleshooting to resolve technical issues, improve process performance, and ensure product quality and compliance.
• Lead the implementation of new technologies, automation systems, and digital solutions to enhance the organization's efficiency, productivity, and innovation.
• Provide technical expertise, mentorship, and guidance to junior engineers and team members, fostering a culture of continuous learning and professional development.
• Stay current with emerging trends, best practices, and advancements in biotechnology, engineering, and related fields, and apply knowledge to drive continuous improvement and innovation.
• Collaborate with internal stakeholders and external partners to support technology transfer, scale-up, and commercialization activities for new biotechnology products and processes.
• Provide Process Engineering design support by working with operation function and Global Engineering teams to define process operation equipment requirements.
• Lead and support the overall process equipment life cycle management responsibilities from the facility restart phase, including but not limited to the generation of user-required specifications, start-up (FAT/SAT), I/O/PQ validation support, and change management.
• In charge of process equipment maintenance system development, including spare parts inventory, calibration and preventive maintenance program, and continuous validation requirements.
• Serve as an SME to support R&D and cGMP manufacturing from Process Engineering perspectives, with responsibilities of troubleshooting process equipment, deviation investigation, CAPA implementation, and engineering audit/visit by clients and regulatory authorities.
• Ensure potential safety hazards are identified/shared and effective corrective actions are rapidly implemented.
• Completes professional-level engineering assignments related to a specific field or discipline. Participates in projects involving designing, fabrication, validating, and manufacturing complex instrument subassemblies, systems, or processes.
• Analyzes, develops, and recommends design approaches required to meet design and production requirements for new or enhanced instruments. Compiles and evaluates design and test data, prepares technical specifications, and determines appropriate limits and variables for product, process, or materials specifications.
• Achieve best practices that meet the biopharma industry standard, including design control and documentation. Implement and support the creation and execution of process control strategies, including process risk assessments.

Qualifications:

• Ph.D., M.S., B.S. in Engineering, or related biotechnology experience equivalent.
• Minimal 10 years of relevant biopharmaceutical Process Engineer working experience.
• The candidate must possess extensive knowledge and experience in bio-manufacturing engineering and have a solid understanding of cGMP facility requirements for clinical and commercial biomanufacturing operations.
• Proven experience in risk mitigation planning and solving complex manufacturing Process Engineering-related problems—the ability to make appropriate judgments and rapidly troubleshoot issues to achieve cGMP production operation success.
• Excellent communication skills. Great team player who can build positive collaboration with internal stakeholders, vendors, and clients to achieve alignment and work effectively.
• Must work in a self-motivated, highly flexible, well-organized, and detail-oriented style with the requirement of some evening conference call time and occasional international travel.
• Must be able to wear appropriate PPE, be able to stand /sit/walk for long periods, and be able to lift 50 lbs occasionally.
• Experience mentoring/guiding junior engineers.

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.