Senior Specialist, Engineering

* Responsible for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing site at Wilson.  This includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation.
* 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.
* Provides written scientific justification for proposed changes by conducting literature search, designing and executing experiments, analytically reviewing current and past data, and demonstrating the impact of process changes on product quality, production efficiency, or productivity.
* Provides technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues.
* Responsible for the accuracy of Packaging Process Descriptions.  This requires a thorough knowledge of the packaging operations, the hazards involved, and the in-process controls necessary to obtain reproducible results.
* Responsible for completing all process engineering/process development activities with the highest regard for all of our Company Divisional policies and Wilson site procedure for safety, quality, and regulatory compliance.
* Review literature pertaining to pharmaceutical packaging in order to introduce new profitable/productivity ideas into the packaging operation.
* Provides technical support in critically evaluating quality standard specifications and methods for raw materials and intermediate and final products.
* 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.
* 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 communication skills.
* 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 the use of Lean Six Sigma tools.
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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