Senior Specialist, Engineering

MSD•Wilson, NC

About The Position

Reporting to the Associate Director of PTO Engineering, the Senior Process/Project Engineer is responsible for providing technical support to Manufacturing Division–Wilson packaging operations (including oral solid dose and bottle packaging lines) as well as medical device assembly lines. This role involves planning, designing, and implementing technical projects while serving as a subject matter expert (SME) for assigned packaging lines and associated processes. The position requires strong technical expertise, project management capability, and knowledge of company standards, procedures, and practices.

Requirements

Minimum of 5 years of relevant industrial experience
Experience working in a GMP pharmaceutical environment
Demonstrated leadership and teamwork skills
Strong analytical and problem-solving ability
Excellent oral and written communication skills
Ability to work effectively with limited supervision
Strong mechanical aptitude with the ability to troubleshoot equipment issues
Device Packaging
Equipment Qualification
Good Manufacturing Practices (GMP)
Packaging
Packaging Engineering
Packaging Operations
Product Packaging
Technical Writing

Nice To Haves

Experience in the pharmaceutical industry
Experience with oral solid dose and bottle packaging systems
Project management experience
Experience with equipment qualification (IQ/OQ/PQ)
Familiarity with Lean Six Sigma tools and methodologies
Current Employees apply HERE
Current Contingent Workers apply HERE
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Responsibilities

Specify, procure, install, and qualify new packaging and medical device assembly equipment.
Provide ongoing technical support, performance monitoring, and troubleshooting for packaging and device assembly equipment.
Partner with site and above-site teams to support the transfer of new products and processes from R&D or other manufacturing sites to Wilson.
Independently or as part of a team, plan, design, and execute technical projects related to packaging and device assembly equipment and processes.
Lead or contribute to project sub-teams, ensuring effective communication and execution.
Drive implementation of new technologies and applications of existing systems.
Serve as the technical lead/SME for assigned packaging lines, providing recommendations and decision support.
Support scale-up and technology transfer of processes from pilot to commercial production, including: Equipment design and qualification, Process demonstration and performance qualification, Process validation (including packaging systems).
Lead and support equipment qualification activities (IQ/OQ/PQ) and ensure adherence to validation standards.
Author and maintain technical documentation, including process descriptions and change controls.
Provide technical assistance to operations for equipment issues and in-line product support.
Lead root cause investigations and support resolution of equipment-related quality events.
Drive process improvements to enhance quality, efficiency, and productivity.
Evaluate data, conduct experiments, and develop scientifically sound justifications for process changes.
Support regulatory and quality activities, including site inspections, audits, and preparation of technical documentation (e.g., NDA supplements, FDA responses).
Ensure all activities comply with company policies, site procedures, safety, and regulatory requirements.
Maintain accurate and up-to-date process documentation and packaging process descriptions.
Review industry literature to identify new technologies and process improvements.
Support evaluation of materials, specifications, and methods for packaging and device assembly.
Provide technical guidance and training to less experienced team members.