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.

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

Knowledge / Skills / Abilities:

• Must be able to read, write and understand English fluently.

• Proficient in Oral & Written communication skills

• Proficient in Microsoft Excel and Project.

• Able to set up experiments for process improvements.

• Ability to prioritize multiple demands in project execution

• Ability to work in a team environment and independently as required.

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.

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Job Locations US-PA-Philadelphia

Job ID 2024-12720