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Process Engineer II

Pfizer


Location:
Andover, MA
Date:
12/06/2017
2017-12-062018-01-06
Pfizer
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Job Details

**ROLE SUMMARY**







The manufacturing scientist/engineer is responsible for execution of the manufacturing process in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance. Participate in the execution of pharmaceutical manufacturing processes, and provide engineering guidance and planning within the assigned Asset Group as a Subject Matter Expert (SME). Provide manufacturing activity guidance as an SME, including product operations, suite clearance and changeover, equipment processing, solution formulation, manufacturing batch record review and special sample coordination. Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities. Provide investigations support, analyze process data and identify and implement process improvements. Provide SME support of process of experimental design with regard to system mixing, mass transfer, and other pertinent aspects of bioprocess system control. As an SME, design, specify, and purchase new or modified equipment based on technology innovation and process needs. Author, approve, and present comprehensive technical presentations, procedures, policies and processing instructions. Successful candidates will be flexible and adaptable, willing to work in a fast-paced, dynamic environment.







**ROLE RESPONSIBILITIES**







+ Executes routine manufacturing activities.



+ Proactive and real-time RFT support of critical operations.



+ Communicate and resolve operational variances.



+ Process monitoring including real time review of process parameters and process data/trend analysis. Communicate process performance across shifts and departments.



+ Implement process enhancements, measure and respond to equipment capability and implement new technologies.



+ Author, review, and approve documentation such as batch records, procedures, and validation reports.



+ Provide input, review, and approval for investigations, commitments, and change controls to ensure changes are value added and processes and equipment are robust.



+ Perform skills training and provide subject matter expertise to training materials.







+ Collaborate cross-functionally to resolve issues and drive improvement.



+ Promote a culture of Innovation and Continuous improvement. Drive changes that support Right First Time, Efficiency, and/or reduced costs.



+ Collaborate with site tech services (STS) to develop programs and strategies for real time process monitoring and right first time.



+ Provide Audit support as SME







**QUALIFICATIONS**



BS or MS in chemical engineering, biology, biochemistry or other related science or engineering field



Engineering degree: BS +2yrs, MS +0yrs (related)



Non Engineering Degree: AS +6yrs, BS +4yrs, MS +2yrs



Familiarity and experience with mammalian cell culture, protein purification and/or solution formulation is not essential, but is highly desirable.



Previous experience in a GMP manufacturing environment desirable.



Previous experience with manufacturing-scale bioreactors/fermenters, centrifuge, column chromatography and/or tangential flow filtration (UF/DF) a plus.



Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.



Previous leadership skills a plus.







**PHYSICAL/MENTAL REQUIREMENTS**



Role tasks will include moving equipment, frequent bending, climbing, lifting (up to 50 pounds) and twisting motions.



Ability to stand for several consecutive hours.



Ability to walk throughout the manufacturing suite, including up and down stairs.







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



2nd Shift, Rotating A/B shift.



The role requires work in a GMP manufacturing suite, which requires gowning.







**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.







**Other Job Details:**







+ **Last Date to Apply for Job: December 18, 2017**



+ **This job is Pfizer Exempt US Grade: 004**



+ US/PR colleagues who are issued an Incident Final Warning (IFW) disciplinary action are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.







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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