Process Engineer

WuXi Biologics•Dundalk, MD

49d

About The Position

The Process Engineer will support the activities of the Manufacturing Technology team with responsibility for providing engineering support to the ongoing requirements for Manufacturing 6 & 7 as well as supporting any future tech transfer projects into MFG 6 & 7. As a Process Engineer, you will join an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the TechOps Team Lead.

Requirements

Third level qualification in a Science or Engineering related subject is preferable.
Thorough knowledge of current Good Manufacturing Practices (cGMP).
Computer Literacy.
Minimum of 5 years’ experience in a large-scale in a Biopharmaceutical/pharmaceutical facility.
Ideally, experience working in a TechOps team in a ‘greenfield’ context of similar size and scale.
Excellent interpersonal, verbal, and written communication skills with ability to work independently and as part of a team.
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.
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.
Interested in change, in challenge, and in building a new future together.

Nice To Haves

Experience and knowledge of DeltaV MCS platform preferred.
Familiarity with Chromatography and Ultra filtration production operations is desirable.

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 in 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.
Implement equipment CAPA’s and performance improvements.
Provide equipment technical support and troubleshooting.
Provide routine Automation support, troubleshooting and maintenance.
Support the implementation of Global Requirement Program tools and techniques within the Operation Unit. (for e.g. Operator Care, PdM, PMO, Work Management)
Identify equipment improvement projects for Core Engineering Unit.
Work with 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.
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.
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 TechOps Lead.
Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.