Senior Specialist, Engineering

Job Description

Reporting to the Associate Director of PTO Engineering, the Senior Process/Project Engineer provides technical support for our Manufacturing Division-Wilson packaging and medical device assembly lines. Responsibilities include specifying, purchasing, installing, qualifying new equipment, supporting and troubleshooting current lines, and leading projects to transfer new products and processes from R&D or other manufacturing sites.

The role plans, designs, and implements technical projects related to packaging and medical device equipment/processes. It requires a strong technical background, project management skills, and knowledge of internal methods and standards. The Engineer serves as a technical subject‑matter expert, recommends decisions for assigned lines, leads implementations of new technologies, and provides leadership and training as needed.

• Scale‑up and technology transfer of pilot processes to production scale, including equipment design, qualification, process demonstration, performance qualification, and validation.
• Manage capital and expense projects for installation and qualification of new packaging and medical device assembly equipment and modifications/optimizations to existing equipment.
• Provide technical assistance to packaging operations for resolving equipment problems and lead root‑cause analysis investigations for equipment‑related quality events.
• Prepare written scientific justification for proposed changes; conduct literature searches, experiments, data reviews, and demonstrate impact on product quality, efficiency, or productivity.
• Support quality and regulatory activities such as site inspections, NDA supplement documents, FDA observation, and environmental process issues.
• Ensure accuracy of Packaging Process Descriptions, maintaining knowledge of hazards and in‑process controls.
• Perform all process engineering and development activities in accordance with Company Divisional policies and Wilson site procedures for safety, quality, and regulatory compliance.
• Review literature on pharmaceutical packaging to introduce profitable and productive ideas into operations.
• Evaluate quality standard specifications and methods for raw materials and products.
• Support design, machinability evaluation, process performance qualification, and qualification of new or modified packaging components and medical device/combination products.
• Authorship of process change controls and implementation of packaging and device assembly equipment/process changes.

• Bachelor of Science in Engineering or related field.

• Minimum of 5 years relevant industrial experience.
• Experience working in a GMP pharmaceutical environment.
• Demonstrated leadership and teamwork skills.
• Excellent analytical ability.
• Proven communication skills (strong oral and written).
• The ability to work under limited supervision.
• Mechanical aptitude to troubleshoot/resolve equipment issues.

• Experience in pharmaceutical industry.
• Experience in medical devices and combination products.
• Project management skills.
• Experience in equipment qualification activities.
• Experience in Lean Six Sigma tools.

Solid line report to:
Associate Director Engineering

Dotted line report to: N/A

Position(s) reporting to this position: N/A

• Adaptability
• Analytical Testing
• Data Analysis
• Detail‑Oriented
• Deviation Management
• Equipment Qualification
• GMP Compliance
• Mechanical Troubleshooting
• Medical Device Management
• Packaging Processes
• Pharmaceutical Management
• Pharmaceutical Packaging
• Process Design
• Process Engineering
• Process Hazard Analysis (PHA)
• Process Optimization
• Project Management
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Strategic Thinking
• Technical Leadership
• Technical Problem‑Solving

• None highlighted beyond those listed above.

We provide accommodations during the application or hiring process for candidates who need them.

We are an equal‑opportunity employer. We prohibit discrimination on the basis of race,…