Associate. Specialist, Engineering

Reporting to the Associate Director of PTO Engineering, the Associate Specialist, Technical Operations Engineer provides technical support for the packaging and medical device assembly lines at the our Company Manufacturing Division Wilson site. This role supports equipment performance and project execution through hands‑on troubleshooting, data review, document preparation/execution, and coordination with Operations, Quality, Maintenance, and other site or above‑site partners. The Associate Specialist will develop technical capabilities in packaging processes, equipment qualification, change control, deviation investigation, capital execution, and system life cycle documentation while supporting the transfer of new products as well as the procurement, installation, and qualification of new equipment at the Wilson site.

• Providing technical assistance to packaging operations in the troubleshooting and of packaging and device assembly equipment problems for in‑line products.
• -Authoring quality incidents and supporting root cause analysis and deviation investigations for process and equipment related quality events
• Assisting with the design, machinability evaluation, and qualification of new or modified packaging components, packaging formats, and Medical Device and Combination Products.
• Supporting scale‑up, technology transfer, and introduction of new products or processes by assisting with equipment readiness, process demonstration, and process performance qualification.
• Preparing, routing, and completing assigned tasks associated with process change controls and completing tasks to implement packaging and device assembly equipment/process changes.
• Building process understanding and robustness by supporting line trials, analyzing equipment performance data, tracking issues, and performing proactive process monitoring.
• Contributing to the site’s permanent inspection readiness by organizing and preparing technical documentation and providing support during regulatory audits.
  
  -Performing site records management activities and assisting with document archival and retrieval.

• Assisting with project administration activities including issuing purchase orders, reconciling invoices, and managing site work flows for the creation and closure of non‑production process orders.

The basic function of this position is to support shopfloor production, problem‑solving, and engineering project execution. Work requires technical acumen, attention to detail, organization skills, and working knowledge of our company's methods, standards, procedure, and practices. This position is expected to build technical subject matter expertise for the assigned packaging lines while providing reliable hands‑on support, coordinating administrative and documentation tasks tied to technical work, and communicating effectively with cross‑functional partners.

• BS in Engineering or equivalent technical degree.

• Mechanical aptitude and interest in troubleshooting packaging and process equipment issues.
• Ability to collect, organize, analyze, and communicate technical information clearly
• Strong oral and written communication skills
• Demonstrated teamwork skills.
• Ability to manage multiple priorities, track actions, and support project documentation and workflows

• Experience in pharmaceutical industry, GMP manufacturing, or packaging operations.
• Experience in Medical Devices and Combination products.
• Experience with project, expense, and documentation management
• Experience in equipment qualification and working with vendors.
• Experience in the use of Lean Six Sigma tools, data trending, or process monitoring.