Requisition ID: PAC000314
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
As the primary US packaging site for Merck's Global Pharmaceutical Operations organization, the Wilson team is seeking a highly motivated individual to serve as a Packaging/Component Engineer (Specialist, Engineering). The Packaging/Component Engineer will provide technical support to the Wilson site as part of the site component engineering team. This team will be responsible for providing packaging and component engineering capabilities to the site focused on effective component life cycle management and packaging continuous improvement. This position will report to the Pacakging/Component Engineering Lead 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 process improvement engineering activities at the site as well as quality risk management.
- Individual contributor position on the site component engineering team (2-3 professional staff)
- Makes sound recommendations to support component consistency, cost effectiveness, and reliability
- Provides technical assessments for packaging components
- Recognizes opportunities for continuous improvement, anticipates customer needs, identifies and implements solutions
- Possesses strong technical and problem solving skills
- Works well in a team environment, collaborating well with peers
FUNCTIONAL EXPERTISE / TEAM RESPONSIBILITIES:
- Troubleshoot line issues potentially related to component performance (including potential for weekend and off-shift work)
- Assist with design transfer process from packaging commercialization team
- Support quality risk management assessments related to packaging operations and components
- 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
- Work with component vendors to develop new/test components and initiate distribution studies
- Coordinate spec changes for components with change control team and align Quality Standards to maintain consistent performance
- Work with above site Packaging Technical Operations team to provide input to upcoming changes and strategic initiatives
- Support Technical Operations in equipment/component interaction assessments and qualifications
- Partner with Procurement and Supplier Management teams for supplier performance monitoring, technical assessments, and new vendor introduction
- Provide technical SME support for deviations and customer complaints
- Technical support to set and improve run standards based on component capability and variability
- Directly supports regulatory inspections and audits
- Author/support component related deviations/CAPAs
Education Minimum Requirement:
Bachelor's or Master's Degree in packaging engineering (or mechanical engineering degree with relevant packaging experience)
Required Experience and Skills:
- Bachelor's or Master's Degree in packaging engineering (or mechanical engineering with relevant packaging experience)
- 0-2 years of relevant experience supporting high volume packaging operations
- Highly motivated and possessed excellent interpersonal, problem solving, statistics and technical skills.
Preferred Experience and Skills:
- Knowledge of formal problem solving techniques such as root cause analysis and/or Lean Six Sigma
- Basic working knowledge of cGMP and of regulatory requirements as they apply to pharmaceutical packaging and distribution
- Project management skills and experience implementing projects
- Technical writing and document review experience (deviations, change requests, standard operating procedures, protocols, etc.)
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Visa sponsorship is not available for this position.
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Job: Packaging Engineering
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name: Merck
Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount