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- B.S./M.S. degree in appropriate engineering/scientific field
- Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry
- Previous experience in writing investigations for atypical events in a manufacturing environment
- Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
- Demonstrated ability to work both independently and as a part of a cross-functional team
- Excellent written and verbal communication skills Responsibilities:
- Providing 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 within five days of event discovery.
- Performing deviation investigations and customer complaints aimed to prevent deviation/complaint 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.
- Supporting team safety, environmental and compliance objectives.
- Managing investigation and complaint 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)
- 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 Comments/Special Instructions Investigation Writing experience- Top skillset needed Nice to have- previous DM experience, previous customer compliant experience, root cause analysis experience
- ID: #49901352
- State: Pennsylvania Westpoint 19486 Westpoint USA
- City: Westpoint
- Salary: $0.00 - $41 per hour
- Job type: Contract
- Showed: 2023-05-10
- Deadline: 2023-07-08
- Category: Et cetera