MFG Senior Process Engineer - Buffer at WuXi Biologics
Reporting to the Manufacturing Buffer Lead, the Senior Process Engineer will play a pivotal role in establishing the Manufacturing Buffer team, with responsibility for providing engineering support to the ongoing requirements for MFG at our WuXi Biologics facility in Dundalk.
Department Description
As Senior Process Engineer Buffer, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the MFG Buffer Lead.
Your 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 Buffer.
Implement equipment CAPA’s 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. (for e.g. Operator Care, PdM, PMO, Work Management)
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.
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.
Coach manufacturing team on OpEx 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.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Technology Lead.
Your Profile
The ideal candidate for this position will have the following:
Qualifications
Third level qualification in a Science or Engineering related subject is preferable.
Knowledge/Experience
Minimum of 8 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 DeltaV MCS platform preferred.
Familiarity with Chromatography and Ultra filtration production operations is desired.
Strong leadership competencies with demonstrated management skills.
Excellent communication skills including computer literacy and ability to work independently and in team.
Strong leadership competencies with demonstrated management skills.
Ability 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.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Collaborative and inclusive approach to work and colleagues.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.
Other Requirements
Must be willing to travel as required internationally to fulfil 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! Don’t miss out on this opportunity to join us. Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com
Seniority level: Mid-Senior levelEmployment type: Full-timeJob function: Manufacturing and ScienceIndustries: Biotechnology Research and Pharmaceutical Manufacturing
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