Engineering Specialist

Job Description

Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to:

• Reporting to the Associate Director of PTO Engineering, the Specialist, Technical Operations engineer is responsible for providing technical support of our Manufacturing Division-Wilson packaging and medical device assembly lines. Responsible for specifying, purchasing, installing, and qualifying new packaging and device assembly equipment. Also responsible for packaging and device assembly equipment performance, support, and troubleshooting for products packaged at our Manufacturing Division-Wilson. Works closely with Wilson and above-site departments for the transfer of new products and processes from our Research & Development Division or other our Manufacturing Division site to our Manufacturing Division-Wilson.

Primary Activities:                                                   
Primary activities include, but are not limited to:

• Responsible for managing 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 the resolution of packaging and device assembly equipment problems for in-line products. This involves leading root cause analysis investigations for equipment-related quality events.

• Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified packaging components and Medical Device and Combination products.

• Technical support for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing Division-Wilson. This includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation.

• Responsible for authoring process change controls and completing tasks to implement packaging and device assembly equipment/process changes.

• Provides technical assistance for quality and regulatory activities including site inspections and preparation of technical documents for FDA observation.

The basic function of this position is to, independently or as part of a project team, plan, design and implement technical projects related to packaging and medical device equipment/processes. Work requires a strong technical background and project management skills, as well as working knowledge of our company's methods, standards, procedure, and practices. Experience in equipment installation and qualification for complex systems. This position requires the engineer to be the technical subject matter expert for the assigned packaging lines and make recommendations for decisions associated with these lines and their associated products. Utilizes strong communication skills to lead project sub teams or be a key contributor on site and above-site sub teams. Leads implementation of new technology and new applications of existing technology.

Minimum education required:

• BS in Engineering or equivalent and minimum of 1 year of experience with packaging/process equipment.

Required Experience and skills:

• Mechanical aptitude to troubleshoot/resolve equipment issues.

• Strong oral and written communication skills

• Demonstrated teamwork skills.

Preferred experience and skills:

• Experience in pharmaceutical industry.

• Experience in Medical Devices and Combination products.

• Project management skills

• Experience in equipment qualification activities.

• Experience in the use of Lean Six Sigma tools.

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