Senior Packaging Component Engineer: Global Impact & GMP

MSD Malaysia; Wilson (NC); On-site; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical

Dental

Vision care and other employee health

401(k) retirement benefits

Paid holidays

Vacation

Sick days

Job summary

Merck, a global health care leader, seeks an experienced Packaging Operations Engineer to drive component changes and packaging system integrity. You will partner with cross-functional teams, manage supplier relationships, and support design transfers for global markets.

The role requires a strong GMP background, project management experience, and hands-on engineering in packaging processes. This position involves some travel and on-site collaboration in US facilities.

Qualifications

• Bachelor of Science (B.S.) degree in engineering or equivalent with minimum 5 years in packaging operations, pharmaceutical unit operations, or process design.
• Master of Science (M.S.) degree in engineering or equivalent with minimum 4 years in packaging operations, pharmaceutical unit operations, or process design.
• Comprehensive background in packaging process and components.
• Experience in GMP environments.
• Project management skills and project implementation experience.
• Strong analytical and decision-making abilities.
• Document writing and review experience (deviations, change requests, SOPs, protocols).
• Knowledge of Medical Device and Combination Product requirements (design control, verification, validation).

Responsibilities

• Author and revise specifications for components with cross-functional teams.
• Collaborate with vendors to develop/test components for GMP and product launches across markets.
• Assist with design transfer and packaging development initiatives.
• Act as Change Owner/PM for component-related changes and SME for site impact assessments.
• Manage GLAMS workflows for component drawings used globally.
• Troubleshoot line issues related to components; manage supplier investigations.
• Provide technical support to improve run standards based on variability.
• Partner with Procurement for supplier performance and new vendors.
• Facilitate machine trials and assess packaging component changes throughout lifecycles.
• Provide SME support for component deviations and customer field complaints.
• Author investigations for site component-related deviations; determine scope, root cause, and corrective actions.
• Support regulatory inspections with packaging engineering input.
• Participate in Design Requirements specs, design reviews, and purchase/functional specs.
• Support FATs and IQ/OQ/PQ with attention to component interaction and packaging system integrity.
• Assist in quality risk management for packaging operations and components.

Skills

Change Control Processes

Coaching Managers

Competency Management

Detail-Oriented

Deviation Management

Engineering Specifications

Packaging Engineering

Packaging Operations

Packaging Processes

Process Design

Risk Management

Lean Six Sigma

Education

Bachelor of Science in Engineering

Master of Science in Engineering

Tools

GLAMS

Job description

Merck, a global health care leader, seeks an experienced Packaging Operations Engineer to drive component changes and packaging system integrity. You will partner with cross-functional teams, manage supplier relationships, and support design transfers for global markets.

The role requires a strong GMP background, project management experience, and hands-on engineering in packaging processes. This position involves some travel and on-site collaboration in US facilities.