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Process Engineer III

Pfizer


Location:
Andover, MA
Date:
02/01/2018
2018-02-012018-03-04
Pfizer
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Job Details

**ROLE SUMMARY**



The Process Engineer role is accountable for operational representation of the Technical team within Polysaccharides manufacturing and delivery of the elements associated with facility/equipment or process change.







**ROLE RESPONSIBILITIES**







+ Responsible for in plant manufacturing operations to ensure the on time delivery of high quality drug substance for commercial use (Polysaccharides manufacturing-Drug substance intermediate for Prevenar 13 vaccine).



+ Lead troubleshooting of manufacturing equipment and control systems.



+ Manage change to equipment, automation, and procedures in the manufacturing area



+ Represent Operations on cross functional projects to improve performance of the site



+ As applicable serve as SMEs for internal Audits and External Audits (FDA, EMEA etc.)



+ Cross functional collaboration with QA Ops, Site technical services (STS) , Quality Control (Analytical and Micro) and Engineering on interdepartmental and cross site initiatives



+ Support investigations with primary focus on complex investigations such as Contamination or process robustness related investigations as applicable.



+ Lead Operations technical team on Process monitoring related tasks that include assessment of flags and trouble shoot as applicable



+ Represent Technical team as a core team member on facility expansion -shutdown that includes review of facility layout, design changes and other associated activities.



+ Lead for change control activities for polysaccharides manufacturing.



+ Responsible for cross site interactions with other Pfizer sites (Grange Castle Ireland, Sanford, NC)



+ participate in Green Belt/Black belt projects related to process robustness







**BASIC QUALIFICATIONS**



BA/BS in Chemical engineering, Biotechnology, biology, biochemistry or related science or engineering field



Minimum of 4 years relevant experience with engineering degree or , MS +2 yrs



Minimum of 6 years relevant experience with science degree or MS +4 yrs



Familiarity and experience with the following unit operations is essential: mammalian cell culture, centrifugation, tangential flow filtration, column chromatography. Previous experience with scale up of these unit operations is desirable.







**PREFERRED QUALIFICATIONS**







+ Hands on experience with the above unit operations at manufacturing scale is highly desirable.



+ Previous experience in a GMP manufacturing environment desirable.



+ Previous experience with process validation and change management desirable.



+ Project management experience is a plus.



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







**PHYSICAL/MENTAL REQUIREMENTS**







Work will include walking throughout the manufacturing suite including up and down stairs.







An ability to cross reference multiple documents and perform a detailed review of documentation is required.







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







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







**OTHER INFORMATION**



Not eligible for relocation







* This job is a Pfizer U.S. Grade 007







**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:February 12, 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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