Pfizer Gene Therapy Operations Specialist II in Sanford, North Carolina
The Gene Therapy Operations Specialist works as part of a team to execute batch activities in a new state of the art gene therapy manufacturing facility in Sanford, NC. The incumbent is will be responsible for performing GMP activities in an assigned area, but is expected to have the flexibility to perform operations across multiple areas (cell culture, purification, solution prep, formulation/fill, pack/label) and products. In addition to operating equipment the operations specialist will be responsible for:
• Completing GMP documentation
• Performing operator care activities
• Identifying ways to improve work and implementing solutions
• Leading and participating in investigations that address increasingly more complex issues
In addition, the operations specialist will be assigned as a team member on cross functional teams and be given project assignment to develop problem solving, technical expertise, and leadership capability.
The Operations Specialist has demonstrated an ability to troubleshoot equipment and automation related issues on the floor and to manage multiple project assignments while balancing primary responsibility of executing batch activities.
The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.
Execute batch activities on-time and without injury or defect.
Troubleshoot equipment and automation issues.
Monitor the status of training and complete all required training prior to performing associated tasks.
Update and maintain information in manufacturing support systems used for planning, variance tracking, and continuous improvement.
Proactively implement improvements to business and manufacturing processes that improve flexibility, eliminate waste, and reduce variability.
Maintain the accuracy of all documentation needed for operations including SOPs, batch records and compounding records.
Execute and sustain the components of the lean management system such as 5S, standard work, and visual management.
Role model OWNIT! behaviors.
Perform pre-task safety checks and demonstrate commitment to developing and maintain a safe workplace.
Execute assigned activities associated with the operator care program.commitment to developing and maintain a safe workplace.
Execute assigned activities associated with the operator care program.
0-2 years experience in Biotech Operations with a MS degree in any of the following disciplines: Biology, Biochemistry, Biotechnology, Chemistry, Chemical Engineering, Microbiology or equivalent science related or engineering discipline.
3 - 5 years experience in Biotech Operations with a BS degree in the above preferred disciplines.
A minimum 6 - 8 years experience with a 2 year associates degree in the above preferred disciplines.
Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing. Other job functions require working in an office setting where sitting and computer usage would be the norm.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
It may be necessary to work shifts according to the manufacturing schedules.
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.
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- Last Date to Apply for Job: 26 March, 2018
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.