Senior Specialist, Engineering - Oral Solid Dose Packaging

About the role

The Senior Specialist Engineer provides technical support for the Manufacturing Division-Wilson packaging and medical device assembly lines. They are responsible for the technology transfer of new products and processes from Research & Development Division or other Manufacturing Division sites to Wilson.

Responsibilities

• Supports the scale-up and technology transfer of pilot processes to production scale for packaging and medical device assembly equipment.
• Manages capital and expense projects for installation and qualification of new packaging and medical device assembly equipment and modifications/optimizations to existing equipment.
• Provides technical assistance to packaging operations in resolving equipment-related or complex quality events.
• Conducts literature searches, designs and executes experiments, and reviews data to justify proposed changes in packaging and device assembly equipment/processes.
• Supports quality and regulatory activities, including site inspections and document preparation for FDA observations.
• Ensures the accuracy of Packaging Process Descriptions and complies with company policies and Wilson site procedures for safety, quality, and regulatory compliance.
• Introduces new ideas into the packaging operation and evaluates quality standard specifications and methods for raw materials and products.
• Supports the design, machinability evaluation, process performance qualification, and qualification of new or modified packaging components and Medical Device and Combination products.
• Authorizes process change controls and implements packaging and device assembly equipment/process changes.
• Supports quality and regulatory activities, including site inspections and document preparation for FDA observations.

Requirements

• Bachelor's degree in Engineering or Industry Technology
• Minimum of 5 years relevant industrial experience
• Experience in Bottle/oral solid dosage form packaging
• Experience working in a GMP Pharmaceutical Environment
• Demonstrated leadership and teamwork skills
• Excellent analytical ability
• Prominent communication skills
• The ability to work under limited supervision
• Mechanical aptitude to troubleshoot/resolve equipment issues

Qualifications

• Device Packaging
• Good Manufacturing Practices (GMP)
• Lean Six Sigma (LSS)
• Oral Solid Dosage
• Pharmaceutical Packaging
• Regulatory Compliance