About Us
WuXi Biologics is a world-class biologics services provider, offering expertise from discovery to commercialization for global clients in the biopharmaceutical and healthcare industries.
We are one of the world's top three contract development and manufacturing companies for biopharmaceuticals, providing our clients with a world-leading open access technology platform.
We enable our clients to research, develop, and manufacture drugs from the concept phase to commercial manufacturing.
We currently employ over 12,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies.
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Job Description
As a TechOps Process Engineer, you will be part of an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
You will report to the TechOps Team Lead and be responsible for supporting the activities of the Manufacturing Technology team.
Your primary focus will be on providing engineering support to the ongoing requirements for Manufacturing 6 & 7 as well as supporting any future tech transfer projects into MFG 6 & 7.
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Key Responsibilities
* Assist in site start-up and project-related activities
* Support package owners on vendor management and equipment or process-related activities and queries
* Generate equipment verification and validation protocols and reports as required
* Review vendor documentation for completeness and accuracy
* Participate in FAT and vendor-related activities
* Support issue resolution during equipment installation, commissioning, and qualification phases
* Participate in verification and validation-related activities as required
* Support CQV execution team as needed
* Evaluate and ensure that equipment meets the requirements of the process
* Implement equipment CAPAs and performance improvements
* Provide equipment technical support and troubleshooting
* Support the implementation of Global Requirement Program tools and techniques within the Operation Unit
* Identify equipment improvement projects for Core Engineering Unit
* Champion and Support Energy saving programs/projects within the Operating Unit
* Conduct Investigation Trending, Change Control write up and close out
* Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented
* Participate in cross-functional project teams as applicable and support audit preparation
* Develop and maintain a database for investigations, or other required department tracking and data analysis needs, as applicable
* Perform all duties in accordance with cGMP requirements, SOP's and controlled documents
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Requirements
* Third-level qualification in a Science or Engineering related subject
* Thorough knowledge of current Good Manufacturing Practices (cGMP)
* Computer Literacy
* Experience and knowledge of DeltaV MCS platform preferred
* Familiarity with Chromatography and Ultra filtration production operations is desirable
* Minimum of 5 years experience in a large-scale in a Biopharmaceutical/pharmaceutical facility
* Ideal experience working in a TechOps team in a greenfield context of similar size and scale
* Excellent interpersonal, verbal, and written communication skills
* Able to think critically and demonstrate troubleshooting and problem-solving skills
* Self-starter and self-motivated; organized with good attention to detail
* Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
* Collaborative and inclusive approach to work and colleagues
* Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations
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Additional Information
Must be willing to travel as required internationally to fulfill the responsibilities of the position.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
Reach beyond yourself and discover your true potential.