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Upstream Process Engineer, Gene & Cell Therapy Technical Support


Sanford, NC
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Job Details


As a member of the Gene and Cell therapy Technical Support Team located in Sanford, NC, the Upstream Process Engineer is technical process owner of assigned Upstream unit operations and serves as a scientific and technical representative for process and equipment related projects.

During the initial phase this role will focus on supporting the Gene Therapy facility start-up, process transfers and process validation. Following execution of process validation the scope of work will include process performance monitoring, support for change controls and deviations as well as identification of process improvements.


+ Designs technical and engineering studies, writes technical reports summarizing study results and generates necessary data to support change impact assessments during process transfers and investigations.

+ Authors process and equipment descriptions, process flow diagrams and risks assessments.

+ Supports change management and implementation for changes to the manufacturing processes and associated systems. Owns change controls related to process changes.

+ Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.

+ Supports process transfers the Sanford Gene Therapy facility.

+ Author and contribute to the Upstream process validation plans, protocols and reports.

+ Benchmark and monitor process performance using statistical tools


+ BS in Bioprocessing, Biomedical Engineering or related discipline is required.

+ 3-6 years of relevant experience in GMP biopharmaceutical industry including Upstream Processing of Mammalian Cells is required

+ Knowledge of bioreactors design is required, knowledge of perfusion cell culture is a plus

+ Experience with cell culture single-use bioprocessing technologies is required

+ Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.

+ Must be self-motivated and work with minimum direction

+ Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.

+ Ability to focus on specific production processes with great attention to details

+ Basic knowledge of Delta Vis a plus


+ No unique physical requirements


-Remains organized &; positive in ambiguous and fast-paced, rapidly changing environment

-Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

-Ability to process complex information and make recommendations with incomplete data set


Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.

Ability to travel- travel time may be up to 20% according to business needs.

**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.

**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.

**Last Date to Apply for Job:** 16 March, 2018

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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