Component Preparation Operator III

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 Pfizers 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 is accountable for knowing understanding demonstrating and ensuring others follow the Pfizers values. Responsibilities may include participating in or providing guidance for investigations as well as assessing existing situations for the purpose of suggesting continuous improvement to increase compliance business effectiveness and innovation. May serve as an assistant team leader and subject matter expert (SME).

Material Handling Assists 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 Ensures proper process parameter compliance while assisting with the production of sterilized materials and components for use in manufacturing of drug product. Communicates effectively all basic technical issues atypical events or deviations instrument malfunctions and methodology problems as they occur. May be responsible for making informed GMP process decisions on behalf of team.

Conducting Assays Accurately performs quality control assays as 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 Ensures proper process parameter compliance while assisting with cleaning sterilizing and assembling critical batch required equipment. Assists in operation and coordination of sterile material transfer 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. May be responsible for making informed GMP process decisions on behalf of team.

Teamwork Participates as a contributing member of the operational support team in sharing the performance of all listed responsibilities including general area maintenance tasks. Works with peers to ensure all required duties are completed in a timely manner and with a high level of quality. Supports mentorship and training of new staff as needed. Conducts frequent cross-departmental communication and promotes collaboration.

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 . Communicates all safety concerns incidents and events as they occur.

Operational Support Actively participates in non-routine activities/projects to support the team goals. May initiate develop and execute project plans for the purpose of continuous improvement within the department. Learns to analyse and interpret project/study/investigation results and findings. Participates in determination of next steps under guidance of supervisor and in compliance with applicable regulations; carries out technical and administrative duties as assigned.

Technical Support Responsible for knowing understanding demonstrating and ensuring others follow the Pfizers values. Experience assisting with investigations to define root cause and provide support with related findings/observations deviations and corrective and preventative actions (CAPA).

• Basic Qualifications

  • A high school diploma or GED with 4 years of relevant experience or an associate degree with 2 years is .

  • International equivalents include 410 years for non-U.S. high school 47 years for vocational school or 14 years for roles needing specialized certifications.

  • Specialized Certifications: 1 to 18 months of relevant experience depending on the certifications depth and relevance

  • Knowledge of biological sterilization methods mathematical calculations and metric system usage.

  Preferred Qualifications

  • Skills training in effective sterilization methods and computerized record keeping desired.

  • 3-6 years of relevant experience in an industrial pharmaceutical production setting preferred.

  • Strong leadership skills and high level of organization desired.

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 without mechanical assistance at least once a shift and lift >50 lbs with assistance.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work in a controlled temperature environment wearing clean room attire. On occasion steam noise chemical odours and fumes may be present; personal protective equipment must be worn for safety reasons.

• Ability to maintain shift work on a 12 hour 2-2-3 rotating schedule. Day or night shift schedule will be .

Relocation assistance may be available based on business needs and/or eligibility.