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Senior Principal Process Engineer

A very senior level Process Engineer role is available with global organization. The Senior Principal Process Engineer will operate on delivery side, no design in this position.
Senior Principal Process Engineer for Device and Combo Products will provide leadership in the following areas:
?Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.
?Reviewing and providing feedback and technical/scientific support.
?Lead change management and implementation for changes to device products and provides training for technical staff on these changes.
?Manage changes to delivery devices together with third party and internal sites to meet regulatory requirements.
?Develop technical impact assessments for related changes; develop execution plan.
?Leadership on technical team for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures
?Perform trending/monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process variance.
?Ensure project deliverables meet their quality, safety, and functional goals, and satisfy the customer.
?Facilitate, support, and/or execute verification of device components/system, including risk assessments, risk mitigation strategies and risk plans.
?Participate in start-up efforts of new equipment, software or processes in manufacturing. Serving as a scientific and technical representative for process-related issues at the facility.
?Identify and lead process/product /device improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
?Establish experimental protocols, conduct experiments, analyze results, and document the information.
QUALIFICATIONS
?BS degree in Engineering with a MS or PhD degree preferred.
?Minimum of 12 years' experience in Device Development, Engineering and pharmaceutical industry
?Familiar with global regulations on devices, drugs, validation/qualification requirements.
?Experience leading teams
Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.


 

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