Filling Technician II

Pfizer Rocky Mount , NC 27803

Posted 2 months ago

Why Patients Need You

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.

ROLE SUMMARY

The Filling Technician II is responsible for the operation of production equipment, performing routine maintenance, preventative maintenance, change over's, adjustments, and repairs of production and process equipment, for the facility and/or utility equipment. .

ROLE RESPONSIBILITIES

  • This position must adhere to all SOPs, cGXPs, and plant quality, safety, and documentation systems requirements.

  • Other related duties essential to these operations or special assignments as required.

  • Operates equipment that has the capability of Isolator Technology, automatic stopper loading and a demonstrated working knowledge of HMI operation.

  • Understands all aspects of the washing, filling, component sterilization (Hydrogen Peroxide and Steam Sterilization) process and operation of the process equipment within this respective area.

  • Operates in Grade A, B, C, D environments and conduct routine aseptic interventions (in a conventional Aseptic or Isolator).

  • Filling Technician II reports to Operations. This incumbent performs as a leader and a technical resource for a group of Production Operators and other technicians.

  • Performs necessary machine set-up, operation, changeover, adjustment, diagnosis, repair, and preventative maintenance on production equipment. Some activities may require work prior to and after normal shift or overtime.

  • Responsible for minimizing production line down time and maximizing efficiencies. Highly proficient at mechanical and electrical system troubleshooting.

  • Communicates openly and clearly with line personnel and supervision to accomplish manufacturing goals.

  • Follow SOPs, cGMPs, batch records, BOMs.

  • Notify Group Leader/Supervisor of all safety and quality issues.

  • Documents all maintenance performed through the use of the work order system and maintenance log books.

  • Keeps accurate GDP records as needed for filling manufacturing and prepares the process steps and parameters with the utmost attention to detail as specified in the batch record

  • Provides recommendation and plan of action to the supervisor on the needed repair of the equipment

  • Ensure that environmental excursions are kept to an acceptable level.

  • Must proactively support shutdowns by creating punch-lists, ensuring spare parts are ordered/ working with the Maintenance team to support and organize maintenance shutdown activities.

  • Must have a good working knowledge of the batch record/reporting system and logbook entry.

  • Load and operate process sterilization equipment per approved loading and placement diagrams

  • Must be able to articulate aseptic techniques and processes to the highest level of management.

BASIC QUALIFICATIONS

  • HS diploma with 4 - 6 years of GMP manufacturing exp

  • Or Associates Degree in Science or Technology and 2-4 years manufacturing exp

  • Demonstrated proficiency in aseptic technique

  • Knowledge of the general trades: i.e., construction, electrical, machine shop. Knowledge of basic mathematics.

  • Demonstrated proficiency of current Good Manufacturing Practices (cGMP) and Good Documentation Practices.

  • Must know general shop safety practices including handling and storage of potentially dangerous equipment.

  • Ensuring adherence to all plant safety rules in area of responsibility

  • Must be self-motivated, able to work independently and have a problem solving mindset.

  • Must demonstrate experience and competence in following detailed instructions.

  • Must be able to read, interpret, and perform job duties as prescribed in the operating procedure.

  • Must be able to read and interpret equipment data and demonstrate ability to communicate work requirement and problems in a concise and accurate manner.

  • Must be able to confirm cleaned equipment meets the requirements of "visually clean" and passing all critical process parameters.

  • Must be able to work in a controlled temperature environment wearing clean room attire. On occasion, steam, noise, chemical odors, and fumes may be present.

  • Required to wear personnel protective equipment as indicated by area standard operating procedures.

  • Must have the ability to recognize when processes, procedures, equipment, product, commodities, etc are out of specifications.

  • Must be able to work with computerized filling system programs

PHYSICAL/MENTAL REQUIREMENTS

  • Stand up to 10-12 hours per shift, twist at waist 20 times per hour, regularly lift up to 35 pounds per activity 20 times per shift, occasionally lift a maximum of 50 pounds per activity 10 times per shift, occasionally may lift over 50 pounds with assistance, walk, climb stairs, climb ladders/walk on catwalks, repetitive use of upper extremities.

Use computer terminal 2 hours per shift, respond to visual warning indicators, respond to audible indicators, respond to color or special visual indicators, work around moving equipment, work on knees occasionally, wear specialized protective clothing, wear PPE (safety shoes/glasses/etc), work in hot or cold environment, work in hearing conservation area

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

7am to 7pm 2-2-3 rotating schedule

OTHER JOB DETAILS

  • Last Day to Apply: December 28th 2021

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Manufacturing

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Filling Technician II

Pfizer