22 days old

Principal Scientist, Facilities and Instrumentation Manager

Pfizer
Chapel Hill, NC 27514
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**ROLE SUMMARY**

Principal Scientist, Facilities and Instrumentation Manager role is responsible for the support of manufacturing of GLP and cGMP grade Phase I/II products in accordance with established SOPs, within a cGMP environment. The role will also work with the Manufacturing and Process Development Teams on new equipment start up and routine calibration and maintenance as well as coordinate and support facilities maintenance programs. Additional responsibilities include significantly contributing to the overall operations of the pilot plant and labs, including identifying and implementing improvement initiatives, in order to achieve production goals and timelines. Also responsible for staying current, regarding current Good Manufacturing Practices (cGMPs) guidelines, Good Laboratory Practices (GLPs), and exhibiting best practices within manufacturing, safety, compliance, investigations, and procedures. The role will be responsible for building out a future support staff through the identification, recruitment and management of key resources.



**ROLE RESPONSIBILITIES**



+ Oversight of vendors for vendor performed process / analytical instrument services

+ Supporting Manufacturing team in trouble shooting and repair issues as required

+ Manage future support staff

+ Performing calibrations on process and analytical instrumentation in support of the continuous operation of the gene therapy facility, including manufacturing, utilities and quality control equipment/systems

+ Troubleshooting and repair of instrumentation and related equipment/systems

+ Performing preventative and predictive maintenance on equipment and related instrumentation and equipment

+ Provide capital project support

+ Perform calibrations on process and analytical instrumentation

+ Create Purchase Orders, schedule and oversee vendor services for process area equipment.

+ Maintain calibration equipment and standards

+ Create and follow SOPs as required to support activities in a cGxP environment

+ Document all work order activities in EAMS and relevant equipment logs

+ Troubleshoot and resolve calibration/instrumentation issues in a timely manner utilizing DMAIC techniques

+ Read and follow equipment schematics, logic diagrams and engineering drawings

+ Support engineering projects to select and install appropriate instrumentation

+ Perform duties in a safe manner with a focus on Zero Injuries

+ Lead and/or participate in continuous improvement activities

+ Specific PPE requirements, including clean room gowning, is frequently required.



**BASIC QUALIFICATIONS**



+ Minimum of AAS degree in electrical, electronics, instrumentation or industrial technology with at least 10 years of experience working with instrumentation and calibrations in a GxP environment or a HS diploma with 15 years of relevant experience is also acceptable.

+ Experience working within a cGxP environment while following SOPs



**PREFERRED QUALIFICATIONS**



+ People leadership experience is desirable

+ Experience with building automation controls systems is desireable



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Schedule is primarily day shift (M-F, 8 hrs) however alternative work schedules may be required to support specific project-related activities.



**OTHER INFORMATION**



+ Eligible Employee Referral Bonus: Yes

+ Eligible for Relocation: Yes

+ \#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.



Research and Development
Posted: 2020-05-04 Expires: 2020-06-04
Sponsored by:
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Principal Scientist, Facilities and Instrumentation Manager

Pfizer
Chapel Hill, NC 27514

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