Pfizer Process Scientist/Engineer I in Andover, Massachusetts
The engineer/ scientist in manufacturing operations 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. Additional roles include using operational and technical knowledge to lead troubleshooting activities, lead tech transfer and start-up activities, provide investigations support, analyze process data, and identify and implement process improvements.
Executes routine manufacturing activities including Purification, Cell Culture, solution formulation, and equipment preparation (set-up, CIP, SIP).
"First-line" technical support within their assigned Asset Group, collaborating with outside groups as needed.Serve as the operations point of contact for campaign start-up with roles in technology transfer, site assessment, generation of cGMP documentation, suite preparation, process execution, and summary reporting. Coordinate suite clearance and product changeover.
Process monitoring including real time review of process parameters and process data/trend analysis. Communicate process performance across shifts and departments. Implement process enhancements, measures and responds to equipment capability and implements new technologies. Support procurement and validation of new equipment and technologies.
Support or champion compliance investigations, commitments (CAPA), and change controls. Provide support during audits and with audit observation closure.
Perform skills training and provide subject matter expertise to training materials.
BA/BS in chemical engineering, chemistry, biology, or other related science or engineering field and 2 years of relevant experience.
Familiarity and experience with purification processes, cell culture, and support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) is not essential, but is highly desirable.
Previous experience in a GMP manufacturing environment desirable.
Previous experience with manufacturing-scale bioreactors a plus.
Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs a plus.
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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.
Last Date to Apply for Job: 08.26.2019
Eligible for Employee Referral Bonus
R (Rotating) (United States of America)
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