Preparation Operator

** Use Your Power for Purpose
** Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.
** What You Will Achieve
*** This incumbent is a member of Component Preparation (CP), operational support, team within the Plant Supply & Logistics focus factory. Under the supervision of the CP team lead, the incumbent may be responsible for material inventory management, general maintenance, cleaning, and testing activities, while also aiding in the preparation and inspection of sterile materials used in drug product manufacturing according to validated parameters.

Incumbent responsibilities will also include cleaning, sterilizing, and assembly of critical batch related equipment, as well as operation of sterilization transfer chambers. All activities shall be performed according to applicable Standard Operating Procedures (SOPs) and/or Batch Records and shall maintain compliance with all relevant regulatory body and license requirements (i.e., FDA, USP, etc.). Accurate records of activities performed will be maintained per data integrity regulations prescribed by current Good Manufacturing Practices (cGMP) and incumbent is responsible for providing communication of all process and specification deviations as they occur.

Incumbent actively participates in teamwork, adheres to safety practices, and routinely performs role functions with minimal supervision. Additional responsibility may include assisting with metrics reporting, as well as initiating and developing project plans for continuous improvements within the department.
* ** Material Handling:
** Participates in management of inventory, transportation, and disposal of all applicable raw materials used in the CP department. Shall receive and maintain fork truck license through safety trainings and certification processes.
* ** Preparing Commodities:
** Assists in the production of sterilized materials and components for use in manufacturing of drug product, as per validated load parameters and applicable procedures. Steps for preparation may include, sterile material transfer, manual equipment loading/unloading, washer and sterilizer operation, vessel operation, and filtration of substances as needed. Communicates effectively, all basic technical issues, atypical events or deviations, instrument malfunctions and methodology problems as they occur.
* ** Conducting Assays:
** Accurately performs quality control assays as required according to provided standard operating procedures. Communicates effectively, all basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems as they occur.
* ** Preparing Equipment:
** Accountable for maintaining a high attention to detail while cleaning, sterilizing, and assembling critical batch required equipment. Routinely operates the sterile transfer of such material into aseptic zones for the purpose of manufacturing. Communicates effectively, all basic technical issues, atypical events or deviations, instrument malfunctions and methodology problems as they occur.
* ** Teamwork:
** Participates as a contributing member of the operational support team in sharing the performance of all listed responsibilities, including general area maintenance tasks such as daily/weekly cleanings and equipment preventative maintenance (PM). Performs data review of peers. Supports mentorship and training of new staff as needed.
* ** Safety Practices:
** Contributes to the housekeeping and cleaning of designated production areas. Safely handles/disposes of chemical and hazardous waste. Complies with all Safety, Environmental, and Security policies as required. Communicates all safety concerns, incidents, and events as they occur.
* ** Operational Support:
** Has opportunity to participate in non-routine activities/projects to support the team goals. May initiate and develop project plans for the purpose of continuous improvement within the department.
** Here Is What You Need** (Minimum Requirements)
* Minimum High School Diploma or GED with 4+ years (+certifications)
* Knowledge of biological sterilization methods, mathematical calculations, and metric system usage
** Bonus Points If You Have** (Preferred Requirements):
* Skills training in effective sterilization methods and computerized record keeping desired.
* 1-4 years of relevant experience in an industrial pharmaceutical production setting preferred.
** PHYSICAL/MENTAL REQUIREMENTS
*** Ability to stand for 10 to 12 hours at a time, sit for 5 to 6 hours at a time, and regularly walk long distances, climb stairs/ladders, walk on catwalks.
* Ability to regularly lift, up to, 50 lbs…