Spclst – Engineering-Off Shift
| Company | Merck |
|---|---|
| Location | North Wales, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Junior, Mid Level |
Requirements
- B.S. degree in Engineering or Science field such as chemical engineering, biochemical engineering, mechanical engineering, biological system engineering.
- Strong troubleshooting and problem-solving skills.
- Demonstrated technical, analytical, and organization skills.
- Strong verbal and written communication skills; interpersonal and team skills; and collaborative skills.
- Ability to manage assignments, working towards deadlines within a schedule.
Responsibilities
- Serves as a subject matter expert (SME) for Live Virus Vaccines (LVV) drug product manufacturing at our company’s West Point Processing Facility.
- Monitors process and equipment performance, and partners with maintenance/operations/reliability engineering to proactively identify and implement process improvements.
- Provides assessment of impact for proposed changes to manufacturing steps or equipment.
- Supports or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
- Collaborates effectively with the area, operators/mechanics, support groups, Quality, planning, project teams, and external component and equipment vendors.
- Provides direct on-shift shopfloor support and responds to shop floor events and process deviations.
- Leads or supports technical discussions and maintains technical process documentation.
- Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, protocols, and change control.
- Supports team safety, environmental, and compliance objective.
- Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies.
- Authors deviation reports and/or events’ information as needed.
- Manages timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
Preferred Qualifications
- Minimum of 2 year experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Engineering, and/or Maintenance.
- Experience in supporting vaccine manufacturing or sterile processing.
- Demonstrated ability to proactively identify and implement process improvements.
- Strong leadership skills.