Packaging Technical Operations, Specialist

3 weeks ago

West Point, United States Merck Sharp & Dohme Full time

West Point Technical Operations is seeking highly motivated individuals to provide engineering technical support for a vaccine packaging facility. The focus areas of the role include (1) planning and execution of packaging projects via Change Control processes and (2) packaging Artwork workflow execution and coordination. Additional areas of responsibility include Deviation Management, protocol development and execution, shop floor support of technical issues and management of the update of Packaging Master Batch Records. Limited additional shift or weekend coverage may be required based on specific assignments.

**The individual in this position will be responsible for the following**:

- Authoring and approving Change Control documentation for process, equipment, serialization and product launch projects. Managing on-time implementation and close-out to meet project, production and supply timelines.
- Coordination and execution of Packaging Artwork workflow processes and projects in support of new and revised artwork.
- Performing deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
- Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements, investigation Corrective/Preventative Actions (CAPAs), or value capture projects that seek to improve yield, reduce cost, or lower cycle times.
- Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.
- Supporting team and IPT safety, environmental, and compliance objectives.
- Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.
- Conducts and designs experimental protocols
- Actively using and championing the use of our Company's production system tools, both in problem solving and day-to-day operational activities.
- Authoring and updating technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation
- Authoring notifications to applicable Health Authorities, in response to deviations or complaints, as required.
- Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
- Provides technical support to manufacturing for complex problems and issues including process/equipment.
- Collaborates effectively with the area Operators/Mechanics, support groups, Quality, and Planning.

**Required Education / Experience**:

- Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, packaging, or related discipline, or equivalent work experience.
- Minimum 1-year experience in pharmaceutical research, manufacturing, or packaging

**Strongly Preferred Experience and Skills**:

- Packaging or vaccine/pharmaceutical manufacturing experience (Operations, Technology, or Quality)
- Change Control Projects
- Deviation management
- IPI, MEDS, SAP
- Technical writing (e.g. investigations, technical protocols/reports)
- Investigative tools (e.g. 5-whys, fishbone).

**NOTICE FOR INTERNAL APPLICANTS**

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

VETJOBS

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for position

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