Job Description

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) coordination and technical development of projects within the Packaging IPT, and (2) management of the Packaging Artwork program and portfolio.

Additional areas of responsibility may 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.

Responsibilities of this role include:

Projects

• Providing leadership to the coordination and technical development of projects within the Packaging IPT.

• Managing 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.

• Summarizes project progress, delays, and improvement opportunities.

• Authors Change Requests and performs impact assessments and technical reviews of Change Requests within the Packaging IPT.

• Requesting master data changes in SAP in support of change control activities.

Artwork

• Managing all aspects of West Point Packaging Artwork, including site support as the QMS Topic 6.9 Sub-System Owner.

• Coordination and execution of Packaging Artwork workflow processes and projects in support of new and revised artwork.

• Ensuring component artwork meets critical supply requirements/deadlines by understanding supply chain and material movement, supporting the use of SAP to update component Revision tables and submit/process required BOM updates for Artwork workflows to include processing master data changes in SAP.

• The role will include support to the Packaging Component Artwork workflow approval process and associated requirements include ensuring appropriate specifications and details in the GLAMS system for printed components via workflows are complete.

• Collaboration with Planning, Quality, Data COE and the market to ensure On-Time delivery of printed components and final packaged material while maintaining compliance.

• Technical Operations lead for serialization.

General

• Collaborating effectively with the area Operators/Mechanics, support groups, Quality, and Planning.

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations, as required.

• Supporting team and IPT safety, environmental, and compliance objectives.

• Actively using and championing the use of our Company Production System (MPS) 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.

• 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.

Required Education / Experience:

• Bachelor's degree in chemical engineering, mechanical engineering, biological sciences, packaging science or related discipline.

• Minimum 4-years experience in pharmaceutical manufacturing, packaging, or equivalent experience.

Strongly Preferred Experience:

• Minimum 2-years experience in the Change Control Process

• Minimum 1-year experience in the Artwork development/approval processes

• IPI, MEDS, MIDAS, GLAMS

• SAP Master Data submission experience

• Technical writing (e.g. change control, technical protocols/reports)

• Experience in Protocol Development

• Experience in applying our Company Production System (MPS) tools and mindset, both in problem solving and day-to-day operational activities

• Experience in application of serialization requirements

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

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.

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 positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:09/27/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R313040