1+ months

Senior Process Engineer

Pfizer
Sanford, NC 27330
**ROLE SUMMARY**

As a member of the Gene Therapy Manufacturing Technical Services Team the Senior Process Eng -Drug Product will play a pivotal role in process validation, launch and commercial production of Gene Therapy Drug Products manufactured in Sanford, NC. 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 BLA submission authoring, process performance monitoring, support for change controls and deviations as well as identification of process improvements.



**ROLE RESPONSIBILITIES**



+ Author process and equipment descriptions, process flow diagrams

+ Design technical and engineering studies, author protocols, write technical reports summarizing study results

+ Author process validation protocols and reports

+ Lead risks assessments.

+ Establish an effective Continuous Improvement feedback loop between Operations, Project teams and the fill finish equipment vendor(s) to incorporate lessons learned

+ Support change management and implementation for changes to the manufacturing processes and associated systems.

+ Support for regulatory submissions and PAI readiness

+ Mentor and train junior colleagues



**QUALIFICATIONS**



+ Degree in Bioprocessing, Engineering, Molecular Biology or related discipline

+ BS with a minimum of 5-8 years or MS with 3-5 years of aseptic Fill Finish unit ops experience in biopharmaceutical industry

+ An in-depth knowledge of Fill Finish unit operations including aseptic processing, and visual inspection

+ Drug Product Process Transfer and Validation experience

+ 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.



**Preferred**



+ Knowledge of statistical tools (e.g. six sigma, process capability, control charting, etc.)

+ PAI readiness experience

+ Experience with Single Use Systems



+ **Last Date to Apply for Job: 5/15/2020**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



**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

Categories

Posted: 2020-05-04 Expires: 2020-08-05

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Senior Process Engineer

Pfizer
Sanford, NC 27330

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