Gene Therapy Operations Specialist II

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  Why Patients Need You
  
  Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
  
  What You Will Achieve
  
  Working with Pfizer's dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods and controls to meet desired quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.
  
  As an associate, your focus on the job will contribute in achieving project tasks and goals. It is your domain knowledge, commitment, collaboration and dedication that will help us achieve new milestones and patients across the globe.
  
  How You Will Achieve It
  
  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 Pfizer 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.
  
  Qualifications
  
  Must-Have
  
  
  • 
    2 - 4 years experience in biotech operations with a BS degree in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, Microbiology or equivalent science related or engineering discipline.
    
    
  
  
  Nice-to-Have
  
  Demonstrated experience in a relevant cell culture manufacturing environment
  
  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.
  
  Staffing to 24/7 fixed or rotating 12 hour shifts according to manufacturing schedules.
  
  Last Date to Apply for Job:1/24/2021
  
  Eligible for Employee Referral Bonus
  

Sunshine Act

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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.

Engineering

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