Packaging Component Engineer

Job Description

Job Description

Job Description:

Responsible for supporting packaging and component engineering capabilities for the Wilson site focused on effective component life cycle management, related quality investigations, lines projects, and packaging continuous improvement projects.

Responsible for process performance support and troubleshooting products packaged at our Wilson location and working closely with other site and above-site groups for the introduction of new products, network transfers and processes as well as external suppliers, packaging commercialization, and global support functions.

This position will report to the Associate Director of Packaging Technical Operations (PTO Component Engineering) and will have frequent interaction with other business units at the site as well as external suppliers, packaging commercialization, and global support functions. The team will also support other engineering activities at the site as well as quality risk management.

Primary Responsibilities:

• Author new and revise specifications for components with cross-functional team and align performance requirements to maintain consistent performance.
• Work with component vendors to develop new/test components to support equipment qualifications, stability, distribution studies, and product launches for various global markets.
• Assist with design transfer process from packaging commercialization team and partner with above site Packaging Technical Operations team to provide input to upcoming changes and strategic initiatives.
• Act as Change Initiator/Project Manager for component related changes and SME for impact assessments/tasks on all site changes for assigned area.
• Initiate/maintain workflows in GLAMS (Global Artwork Management System) for printed component structural drawings for usage by Print Coordinators and global markets in product artwork development.
• Troubleshoot line issues potentially related to component performance (including potential for weekend and off-shift work); Initiate/manage events in the supplier Incident Management System (IMS) for supplier investigations.
• Technical support to set and improve run standards based on component capability and variability.
• Partner with Procurement and Supplier Management teams for supplier performance monitoring, technical assessments, and new vendor introduction.
• Facilitate machine trials and provide technical assessments for packaging component introduction and changes throughout product lifecycle.
• Provide technical SME support for component related deviations and customer field complaints.
• Author quality event investigations for site component related deviations to prevent deviation recurrence; includes determination of event scope, impact assessments, root cause, identifying corrective/preventative actions, and remediation steps/final dispositions.
• Directly supports regulatory inspections and audits; Provide engineering support to packaging operation assuring technical site readiness and regulatory agency observations.
• Participate in Design Requirements Specifications, Design Reviews, Review of Purchase Specs and Functional Spec.
• Participate on FATs and execution of IQ/OQ/PQ with focus on component interaction and packaging system integrity.
• Support quality risk management assessments related to packaging operations and components.

Education Minimum Requirements:

• Bachelor of Science degree in packaging sciences or engineering related field

Preferred Experience and Skills:

• A minimum of two (2) years' experience in packaging operations, pharmaceutical unit operations, or process design.
• Prior Co-Op/Intern experience with comprehensive background in packaging process and components.
• Experience working in GMP environment.
• Effective analytical and decision-making ability.
• Knowledge of formal problem-solving techniques such as root cause analysis and/or Lean Six Sigma.
• Technical writing and document review experience (deviations, change requests, standard operating procedures, protocols, etc.).

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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Search Firm Representatives Please Read Carefully
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):

Requisition ID:R250340