Overview

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.

Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

Our parent company, WuXi AppTec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally WuXi AppTec spans to more than 39,000 employees with 32 facilities in 9 countries.

The Manager of Engineering Strategizes and manages capital and process engineering projects to increase the capability and capacity of WuXi ATU in cell and gene therapies. Applies project management and engineering skills, and GMP knowledge in manufacturing of Advanced Therapy Medicinal Products (ATMPs) for all aspects of project delivery from feasibility studies, detailed design, construction, equipment optimization and introduction, commissioning, qualification, and hand over to the end users. Establish best project engineering standards and practices for capital project execution.

Leads team of engineers responsible assisting in tech transfer from Process Development to Manufacturing. Establishes commissioning and qualification strategies for utilities, building mechanical, electrical and monitoring systems. Coordinates and manages the requirements of other functional groups such as EHS, QA, Manufacturing, Testing Operations, Facilities, Metrology and Validation for overall project delivery. Directly responsible for managing project engineering project costs, and schedules.

Responsibilities
• Manage multiple capital and renovation projects from conceptual through detailed design, commissioning and qualification.
• Manage outside engineering consultants, construction managers and contractors.
• Establish RFP, Bid Analysis and cost estimating standards and practices for capital project execution for both facilities and process equipment.
• Establish design basis for GMP laboratories and GMP ATMP manufacturing suites.
• Strategize on HVAC, BAS, and electrical commissioning and qualification of clean utilities.
• Manage multiple singe-use process equipment projects from conceptual through detailed design, commissioning and qualification for ATMP manufacturing.
• Provide technical guidance and project management support to Project and Process Engineers.
• Review and approve design documentation including engineering calculations, specifications and drawings for process equipment, HVAC, piping/plumbing, and electrical.
• Review and approve commissioning and qualification protocols.
• Provide troubleshooting support for facility equipment and utility systems.
• Coordinates project engineering support to other departments
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards .
• Assists process engineers with equipment trouble shooting.
• Perform job specific tasks in compliance with applicable Regulations,

Qualifications
• 8+ years as Biopharmaceutical Project Engineer
• Personnel coaching, supervisory and management experience.
• Bachelors' degree in Mechanical Engineering. PE preferred.

Knowledge / Skills / Abilities:
• Proficient in Oral & Written communication skills
• Must be able to read, write and understand English fluently.
• Proficient in Microsoft Word, Excel, and Projects
• Ability to prioritize multiple demands in project management

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.