Process Engineer Mfg 7
Wu Xi Biologics is a world-class biologics services provider from discovery, through to commercialisation. We offer global clients in the biopharmaceutical and healthcare industries our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU and Asia. The company currently employs over employees worldwide, and are providing services to over clients globally, including of the top biopharmaceutical companies.
Job description: Senior Process Engineer MFG 7 Reporting to the Manufacturing Technology Lead, the Senior Process Engineer will play a pivotal role in establishing the Manufacturing Technology team, with responsibility for providing engineering support to the ongoing requirements for MFG 7 as well as supporting any future tech transfer projects into MFG 7.
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 & 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/Execute/Lead verification & validation related activities as required.
* Support CQV execution team as needed.
* Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state.
* Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit.
* Main point for communications with the Core Engineering group for MFG 7.
* Implement equipment CAPAs and performance improvements Execute and lead equipment verification, validation & revalidation protocols as required.
* Provide equipment technical support and troubleshooting.
* Provide routine Automation support, troubleshooting and maintenance.
* Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit.
* Drive the use of PI to provide business efficiency Identify equipment improvement projects for Core Engineering Unit.
* Work with the portfolio management process to identify projects/support demands from the Core Units.
* Champion and Support Energy saving programs/projects within the Operating Unit.
* Write equipment assessments to support investigation closure.
* Conduct Investigation Trending.
* Change Control write up and close out.
* Lead / provide SME input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments and summaries.
* 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.
* Provide input and work with the MFG leadership team to deliver the MFG objectives.
* Support audit preparation.
* Coach manufacturing team on Op Ex tools and use OE systems as the basis for identifying improvements.
* Implement and support continuous improvements that reduce cycle times and operational costs.
* Coach production personnel in manufacturing equipment as required.
* Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable.
* Complete biennial review and PQS updates.
* Support the disposition process.
* Ensure all data ready in timely fashion in support of Opu disposition metric.
* Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
Qualifications:
* Third level qualification in a Science or Engineering related subject is preferable.
* Minimum of years experience in a large-scale in a Biopharmaceutical/pharmaceutical facility.
* Ideally, experienced in establishing a Manufacturing Technology team in a greenfield context of similar size and scale.
* Excellent communication skills including computer literacy and ability to work independently and in a team.
* Thorough knowledge of current Good Manufacturing Practices (cGMP).
* Experience and knowledge of Delta V MCS platform preferred.
* Familiarity with Chromatography and Ultra filtration production operations is desired.
Benefits:
* Bonus
* Life Assurance
* Parking
* Pension
* VHI
Others:
* Must be willing to travel as required internationally to fulfil the responsibilities of the position.
* Collaborative and inclusive approach to work and colleagues.
* Engage cross functionally in conjunction with a site-based team.
* Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations.
* Results oriented, with the ability to manage multiple priorities in a short period of time.