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 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 is accountable for knowing, understanding, demonstrating, and ensuring others follow the Pfizer's 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 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 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 required. 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 Pfizer's 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 required. + International equivalents include 4-10 years for non-U.S. high school, 4-7 years for vocational school, or 1-4 years for roles needing specialized certifications. + Specialized Certifications: 1 to 18 months of relevant experience depending on the certification's 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 required. Work Location Assignment: On Premise The salary for this position ranges from $25.37 to $42.29 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - North Carolina - Rocky Mount location. Relocation assistance may be available based on business needs and/or eligibility. **Sunshine Act** Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. **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. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Manufacturing