22 days old

Principal Device Engineer MDCP

Pfizer
Rocky Mount, NC 27804
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**ROLE RESPONSIBILITIES**



+ The primary role of the Senior Principal Process Engineer - Device and Combo Products, Technical Services, is to provide leadership in the following areas: Manage changes to delivery devices together with third party and internal Pfizer sites to meet regulatory requirements.

+ Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.

+ Reviewing/providing feedback and technical/scientific support, i.e. remediation initiatives, plan reports, etc.

+ Leading change management and implementation for changes to device products or the associated manufacturing processes and systems, provides training for technical staff on these changes.

+ Develop technical impact assessments for related changes; develop execution plan.

+ Supporting manufacturing, engineering and validation to implement those changes. 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.

+ Collaborates with technical staff to implement process technology initiatives.

+ Input and feedback on concepts/improvements for drug delivery systems. Technical support for equipment and process validation activities conducts process overview training to support implementation of new process technologies and assists in defining the scope of capital projects.

+ Establish experimental protocols, conduct experiments, analyze results, and document the information.

+ Plan and execute studies; write technical reports summarizing results; generating / organizing necessary data to support product impact assessments during discrepancies and investigations.

+ Partnering with manufacturing to meet the production schedules, ensure commercial supply, uphold quality standards, driving towards zero defects



**BASIC QUALIFICATIONS**



+ BS or higher degree in Mechanical, Materials, Biomedical, Chemical or Manufacturing Engineering or related Science is required. MS or PhD degree preferred. Minimum of 7 years experience in Device Development, Engineering, pharmaceutical industry or equivalent education preferred.

+ 5+ or more years in a Manufacturing facility.

+ Familiar with global regulations on devices, drugs, validation/qualification requirements.

+ Excellent communication skills and attention to details.

+ Demonstrated team leadership abilities



+ **Last Date to Apply for Job: 15 April, 2020**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



\#LI-PFE



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Engineering
Posted: 2020-03-17 Expires: 2020-05-04
Sponsored by:
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Principal Device Engineer MDCP

Pfizer
Rocky Mount, NC 27804

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