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Biotech Process Engineer, Tech Transfer Focus; 1st shift M


Andover, MA
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Job Details

Job Title Biotech Process Engineer, Tech Transfer Focus; 1st shift M

JobID 1047377-1852

Location: Andover, MA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

The Technical Project Lead role is accountable for operational representation and delivery of the elements associated with facility/equipment or process change in Suites C and D. This includes tech transfer of products/ processes to and from the facility, product re-entry, and changes to improve process robustness and facility capability.#LI-SA1


*Complete site assessment including process flow diagrams, equipment selection, material planning, and operations schedule for clinical and/or commercial products to be manufactured in the suites C and D. *Act as the operations lead for tech transfers to and from the suites C and D. This work includes interface with the donating or receiving organization as well as operations staff. It also includes technical oversight of campaigns. *Manage change to equipment, automation, and procedures in the manufacturing area.*Author and/or reviews manufacturing batch records, solution formulation records, and standard operating procedures.*Represent operations on cross functional projects to improve performance of the site.*Drive continuous improvement in the work processes associated with tech transfer, product entry to the manufacturing area, and change management.


BA/BS in chemical engineering, biology, biochemistry or related science or engineering fieldMinimum of 4 years relevant experience with engineering degree or , MS 2 yrsMiniumum of 6 years relevant experience with science degree or MS 4 yrsFamiliarity 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. 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, change management, and tech transfer desirable. 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.The role requires occasional off shift support of manufacturing operations.

*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.

*Biotech Process Engineer, Tech Transfer Focus; 1st shift M*
*Andover, Massachusetts*

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