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Gene Therapy Senior Process Engineer

Company: Pfizer
Location: Sanford
Posted on: October 16, 2020

Job Description:

ROLE SUMMARYThe Senior Manufacturing Process Engineer, Downstream serves as an operations and technical expert supporting gene therapy drug substance purification. The incumbent should possess expertise in multiple areas that include:Downstream / Purification* DeltaV / Unicorn* Single Use Technology* Column chromatography and experience leading column packing activities* Ultrafiltration / Diafiltration* Virus clearanceThe incumbent is expected to have both substantive experience and knowledge that can be used to troubleshoot and solve problems on the floor independently. 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 incumbent is expected to have excellent written and oral communication skills.The Senior Manufacturing Process 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 Process Engineer will have responsibility for identifying areas of high risk and proactively implementing improvements, interfacing with site engineering, maintenance/calibrations, and technical operations to implement facility and process improvements, leading complex process-related investigations, implementing CAPA, and managing overall change in the area.The incumbent must be able to work independently with limited direction, role model leadership behaviors, ability to influence across multiple functional groups and/or levels of the organization and be capable of representing the Operations Manager in cross-functional forums.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 RESPONSIBILITIESTroubleshoot 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 concepts. Identify areas of high risk for equipment failure and human performance errors and proactively implement improvements. Independently interface closely with external vendors driving operational needs and resolution. 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. Ability to author and execute studies and protocols for downstream operations. Maintain inspection readiness of area. Role model leader behaviors. Partner with EHS to build processes, tools, and mindsets that ensure a zero-injury workplace.QUALIFICATIONSA minimum of a BS degree 5- 8 years of experience; MS 3-5 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering discipline.* Last Date to Apply for Job: 10/19/2020* Eligible for Relocation Package* Eligible for Employee Referral Bonus* #LI-PFESunshine ActPfizer 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 EligibilityPfizer 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

Keywords: Pfizer, Sanford , Gene Therapy Senior Process Engineer, Engineering , Sanford, Florida

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