Overview

Lead and manage process equipment introduction and process improvements to increase the capability and capacity of WuXi ATU in cell and gene therapies. Apply process engineering principles and GMP knowledge in manufacturing of Advanced Therapy Medicinal Products (ATMPs) to improve and troubleshoot current processes. Directly responsible for meeting user requirements and project schedule for project delivery from feasibility through commissioning/qualification, and hand over to the end users. Coordinate with other functional groups such as EHS, QA, Manufacturing, Testing Operations, Process Development, Facilities, Metrology, Validation, and IT for project delivery. Directly responsible for tracking cost, schedule, targets and achievements.

Responsibilities

• Manage multiple single-use process equipment projects from conceptual through detailed design, commissioning and qualification for ATMP manufacturing.• Perform troubleshooting of process equipment.• Applies sound biopharmaceutical process engineering knowledge to optimize current process of high complexity with a multidisciplinary team.• Support end users to define process equipment User Requirements, and establish Design Basis.• Issue Request for Proposals (RFP) to equipment vendors. Specify equipment performance and design requirements. Perform technical and commercial bid evaluations and recommend a vendor. Manage outside engineering consultants, and equipment vendors.• Review and approve design documentation including engineering calculations, specification and drawings (e.g. Process Flow diagrams, P&IDs) for process equipment/systems.• Support, review and approve process equipment/system commissioning and qualification protocols.• Manage manufacturing suite and testing operations laboratory changeovers.

Qualifications

• 5 ~ 10 years of sterile drug manufacturing experience• Working knowledge of current Good Manufacturing Practices (cGMP)• Bachelors’ degree in Chemical Engineering, or Mechanical Engineering. Masters’ or PE preferred, or equivalent experience

New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying your vaccination status or approving an exemption request prior to your start date. If you wish to be considered for a medical or religious exemption, request an exemption by notifying WuXi as soon as possible, but no later than one week before your start date.

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.