Senior Specialist, Engineering

** Job Description*
* ** Position Summary*
* Reporting to the Associate Director of PTO Engineering, the Senior Process/Project Engineer is responsible for providing technical support to Manufacturing Division-Wilson packaging operations (including oral solid dose and bottle packaging lines) as well as medical device assembly lines.

This role involves planning, designing, and implementing technical projects while serving as a subject matter expert (SME) for assigned packaging lines and associated processes. The position requires strong technical expertise, project management capability, and knowledge of company standards, procedures, and practices.

** Key Responsibilities*
* + Specify, procure, install, and qualify new packaging and medical device assembly equipment.

+ Provide ongoing technical support, performance monitoring, and troubleshooting for packaging and device assembly equipment.

+ Partner with site and above-site teams to support the transfer of new products and processes from R&D or other manufacturing sites to Wilson.

** Project & Technical Leadership*
* + Independently or as part of a team, plan, design, and execute technical projects related to packaging and device assembly equipment and processes.

+ Lead or contribute to project sub-teams, ensuring effective communication and execution.

+ Drive implementation of new technologies and applications of existing systems.

+ Serve as the technical lead/SME for assigned packaging lines, providing recommendations and decision support.

** Process Support & Validation*
* + Support scale-up and technology transfer of processes from pilot to commercial production, including:

+ Equipment design and qualification

+ Process demonstration and performance qualification

+ Process validation (including packaging systems)

+ Lead and support equipment qualification activities (IQ/OQ/PQ) and ensure adherence to validation standards.

+ Author and maintain technical documentation, including process descriptions and change controls.

** Operations Support & Continuous Improvement*
* + Provide technical assistance to operations for equipment issues and in-line product support.

+ Lead root cause investigations and support resolution of equipment-related quality events.

+ Drive process improvements to enhance quality, efficiency, and productivity.

+ Evaluate data, conduct experiments, and develop scientifically sound justifications for process changes.

** Quality & Compliance*
* + Support regulatory and quality activities, including site inspections, audits, and preparation of technical documentation (e.g., NDA supplements, FDA responses).

+ Ensure all activities comply with company policies, site procedures, safety, and regulatory requirements.

+ Maintain accurate and up-to-date process documentation and packaging process descriptions.

** Additional Responsibilities*
* + Review industry literature to identify new technologies and process improvements.

+ Support evaluation of materials, specifications, and methods for packaging and device assembly.

+ Provide technical guidance and training to less experienced team members.

** Education Requirements*
* + Bachelor's degree in Engineering or Industrial Technology (or related discipline)

** Required Experience & Skills*
* + Minimum of 5 years of relevant industrial experience

+ Experience working in a GMP pharmaceutical environment

+ Demonstrated leadership and teamwork skills

+ Strong analytical and problem-solving ability

+ Excellent oral and written communication skills

+ Ability to work effectively with limited supervision

+ Strong mechanical aptitude with the ability to troubleshoot equipment issues

** Preferred Experience & Skills*
* + Experience in the pharmaceutical industry

+

Experience with oral solid dose and bottle packaging systems

+ Project management experience

+

Experience with equipment qualification (IQ/OQ/PQ)

+ Familiarity with Lean Six Sigma tools and methodologies

*
* Required Skills:

*
* Device Packaging, Equipment Qualification, Good Manufacturing Practices (GMP), Packaging, Packaging Engineering, Packaging Operations, Product Packaging, Technical Writing

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current…