Pfizer Process Scientist/Engineer II (Cell Culture) in Andover, Massachusetts
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.
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, biology, biochemistry or other related science or engineering field. - 2-6 years relevant experience. - Familiarity and experience with purification processes, mammalian 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.PHYSICAL/MENTAL REQUIREMENTS:- Daily routine may require moving heavy equipment, standing for long periods of time, and/or significant walking throughout the suite including up and down stairs. - Requires the moving of heavy equipment and the ability to lift 50 pounds.- The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:- 2nd shift, 2PM -2AM, rotating including weekends
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.
Process Scientist/Engineer II (Cell Culture) Andover, Massachusetts 1034515