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.
What You Will Achieve
You will help Pfizer ensure that all the production and packaging machinery is up and running. You will be relied on to conduct preventive, predictive and corrective maintenance of our machinery. You will also perform specification checks and help interpret blueprints, sketches and engineering specifications. You will determine the sequence of operations and method of setup as well as assess the requirements of material, parts and equipment.
Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
ROLE SUMMARY: The Filling Technician III 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
SME for process operations as it relates to Isolator Technology, Active RAB technology, utilizing 100% IPC (In-Process Capability) analysis, ATEC automatic Stopper loading and a high 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 minimum of conventional Aseptic, RABs or Isolator production environment) and be able to coach/train others on the proper techniques for all applicable interventions in those environments.
Filling Technician III reports to Operations. This incumbent performs as an SME for operations and technical resources outside the department.
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 system troubleshooting and limited hardware and software trouble shooting. 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 the highest level of accuracy in GDP and process related errors 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 strong working knowledge of the batch record/reporting system, logbook entry and basic understanding of impact of cleanroom design modifications.
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.
Qualifications
Must-Have
HS diploma with 6+ years of GMP manufacturing exp
Or associate degree in science or technology and 4+ years GMP manufacturing exp
Demonstrated proficiency in aseptic technique.
Must be self-motivated, able to work independently and have a problem-solving mindset.
Must be able to work with computerized filling system programs.
Demonstrated experience and competence in following detailed instructions.
Have working knowledge of chemistry, filling, sterilization, and the filtration process.
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.
PHYSICAL/MENTAL REQUIREMENTS
Stand up to 8-12 hours per shift, sit for up to 2-4 hours per shift, twist at waist 10 times per hour, regularly lift up to 20 pounds per activity 5 times per shift, occasionally lift a maximum of 50 pounds per activity 1 time per shift, walk, climb stairs, climb ladders/walk on catwalks
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
None
OTHER JOB DETAILS
Last Date to Apply for Job: 09/27/2023
Work Location Assignment: On premise
Eligible for Relocation Package: No
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.
Manufacturing
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