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Key vaccine product franchises are experiencing significant growth requiring staffing. This is a rotational assignment as the candidate will initially be assigned to technical operations at the West Point site within vaccine bulk processing and will then transition to a full time assignment to support active capital projects to increase vaccine bulk manufacturing capabilities.
The Specialist, Technical Services in the BioBacterial Manufacturing End-to-End provides engineering technical support to the manufacture of liquid vaccines while actively supporting, participating in, and embracing an empowered team culture. In this role, the Specialist will work as an individual contributor or as lead to a project. Additionally, this role will contribute to the performance and results of a department, and anticipate and interpret client and/or customer needs to identify and implement solutions. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.
The selected candidate will be responsible for:
- Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations.
- Conducting real time investigations with the goal of fully understanding root cause and product impact
- Performing 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. 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).
- Supporting 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).
- Executing projects and assigned studies in a right-first-time manner.
- Actively using and championing the use of Lean Six Sigma (LSS) and Merck Production System (MPS) tools, both in problem solving and day-to-day operational activities
Education Minimum Requirement:
- B.S. in Engineering Field
Required Experience and Skills:
- Minimum of 2 years relevant work experience
- Engineering or science educational background
- Demonstrated ability to work both independently and as part of a team
- Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills
Preferred Experience and Skills:
- Support of vaccine operations or technical services support.
- Experience with troubleshooting biotech and manufacturing equipment.
- Experience with Trackwise, MIDAS, SAP
- Ability to read Piping and Instrumentation Diagrams
- Support of deviation investigations and/or project work
- LSS/MPS certification / experience