27 days old

Senior Manufacturing Engineer Gene Therapy

Pfizer
Sanford, NC 27330
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**ROLE SUMMARY**

The Senior Manufacturing Engineer serves as an operations and technical expert supporting gene therapy drug substance and drug production. The incumbent should posses expertise in multiple areas that include:

Upstream



+ DeltaV

+ Single Use Technology

+ Cell culture production from roller bottle to 2,000 scale



Downstream



+ DeltaV / Unicorn

+ Single Use Technology

+ Column Chromatography

+ Ultrafiltration

+ Homgenization



Drug Product



+ Rockwell Automation

+ Formulation / Sterile Vial Filling

+ Isolator Technology

+ Packaging and labeling



The incumbent is expected to have both substantive experience and knowledge that can be used to troubleshoot and solve problems on the floor. The incumbent will partner with the operations manager and operations specialists to ensure the area is in continuous state of audit readiness and should have experience in handling regulatory inspections.

The Senior Manufacturing Engineer will develop operators by sharing knowledge of operations and process design and coaching on ways to reduce waste and variability. In addition the Senior Manufacturing Engineer will have responsibility for identifying areas of high risk and proactively implementing improvements, interfacing with site engineering and technical operations to implement facility and process improvements, leading complex process-related investigations, implementing CAPA, and managing overall change in the area.

The incumbant must be able to work independently with limited direction, role model leadership behaviors, and be capable of filling in for the Operations Manager.

The incumbent is expected to maintain GMP documentation and documenting the manufacture of clinical ad commercial material. The incumbent must comply with applicable safety, occupational health, loss prevention and environmental requirements.



**ROLE RESPONSIBILITIES**

Troubleshoot and solve operational, automation, and process-related problems. Champion and implement improvements to business and GMP manufacturing processes that improve flexibility, eliminate waste, and reduce variability and risk. Develop operators knowledge and skillset in GMP operations and process engineering Identify areas of high risk for equipment failure and human performance errors and proactively implement improvements Interface with site engineering and technical operations to implement facility and process improvements Leading complex process-related investigations, implementing CAPA, and managing overall change in the area. Maintain inspection readiness of area Role model leader behaviors Partner with EHS to build processes, tools, and mindsets that ensure a zero injury workplace.



**QUALIFICATIONS**

A minimum of a BS degree + 5 years of experience; MS + 3 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering discipline.



**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.



+ Last Date to Apply for Job: 5/10/2020Eligible for Employee Referral BonusEligible for Relocation Package



**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.



Manufacturing
Posted: 2020-04-30 Expires: 2020-05-31
Sponsored by:
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Senior Manufacturing Engineer Gene Therapy

Pfizer
Sanford, NC 27330

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