Job Description
In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, this role will be temporarily based in a and exact timing of the departmental move to Rahway, NJ will be communicated at a future date.
The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of deviation management, customer complaints, validation and product franchise. The primary focus of assignments will be in customer complaint investigations.
Position Responsibilities
Performing customer complaint investigations, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment and where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Providing on-the-floor assistance of operational and technical issues; collaborating with the shop floor to provide immediate answers to deviations and potential deviations
Conducting real time investigations with the goal of fully comprehending root cause and product impact within five days of event discovery
Conducting deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment and where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times
Preparing source documentation for regulatory filings, supporting requests for regulatory inspections related to process overviews, investigations, projects and validation
Authoring updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures)
Leading Team safety, environmental and compliance objectives
Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning)
Implementing projects and assigned studies in a right-first-time manner
Actively using and championing the use of Lean Six Sigma (LSS) and our Company Production System (MPS) tools, both in problem solving and day-to-day operational activities
Education
B.S. or B.A. in Mechanical or Chemical Engineering degree or other science degree
Required Experience | Skills
Minimum one year of relevant work
Engineering or science educational background
Work both independently and as a part of a Team
Demonstrated leadership and teamwork skills, excellent analytical abilities, and established written and verbal communication skills
Preferred Experience | Skills
Minimum one year in a GMP environment
Support of vaccine operations or technical services support
Troubleshooting biotech equipment and closed system processing
Trackwise, MIDAS, SAP
Ability to read Piping and Instrumentation Diagrams
Support of deviation investigations and/or project work
LSS/MPS certification