Packaging Technical Operations - Specialist-Engineering

Specialist, Technical Operations Engineer

Position Overview

Reporting to the Associate Director of PTO Engineering, the Specialist, Technical Operations Engineer provides technical support for the packaging and medical device assembly lines at the our Manufacturing Division Wilson site. This role is responsible for equipment performance through providing on-site support and troubleshooting of packaging and device assembly operations. The Specialist works closely with Wilson and above-site departments to support the transfer of new products and processes from our Research & Development Division or other of our Manufacturing Division sites to the Wilson site.

In addition, the role collaborates with site and global Packaging Technology as well as Global Engineering Services teams to specify, procure, install, and qualify new packaging and medical device assembly equipment.

Primary Activities

• Providing technical assistance to packaging operations in the resolution of packaging and device assembly equipment problems for in-line products.
• Leading root cause analysis and authors deviation investigations for process and equipment related quality events.
• Providing technical support for the design, machinability evaluation, and qualification of new or modified packaging components and Medical Device and Combination Products.
• Providing technical support for the scale-up and technology transfer of pilot processes to production scale. This includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation.
• Leading small-scale and supporting large-scale capital projects by partnering with Packaging Technology and Global Engineering Services, respectively, on activities including equipment design, procurement, and qualification.
• Authoring process change controls and completing tasks to implement packaging and device assembly equipment/process changes.
• Building and enhancing process robustness through designing and conduct line trials, analyzing equipment performance data, and implementing proactive process monitoring strategies.
• Contributing to the site's permanent inspection readiness by authoring and reviewing technical documentation and providing support during regulatory audits.

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 assembly 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 complex equipment installation and qualification is desired for leading implementation of new technology or new applications of existing technology.

This position requires the engineer to be the technical subject matter expert for the assigned packaging lines and to make recommendations for decisions associated with these lines and their associated products. Strong communication skills are required to lead project sub teams or be a key contributor on site and above-site sub teams.

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.

Required Skills:

Capital Projects, Global Engineering, Lean Six Sigma (LSS), New Product Development, Packaging Optimization, Packaging Processes, Procurement, Project Management, Six Sigma, Teamwork, Technical Projects, Written Communication

Preferred

Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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