Aseptic Production Lead GPA Vials - Rotating

Pfizer Inc.

McPherson, KS

Job posting number: #7137182 (Ref:pf-4880403)

Posted: March 30, 2023

Application Deadline: Open Until Filled

Job Description


  • Job Description

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 monitor and respond to basic functioning needs of area equipment, i.e. line speed, feeding product, line clearances, cleaning, loading or unloading materials adhering to all SOPs, cGMPs (current Good Manufacturing Practices), plant quality, safety, and documentation systems requirements.

As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will assist with training others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to patients.

How You Will Achieve It

  • Manage own time, professional development and be accountable for own results.
  • Monitor and respond to basic functioning needs of area equipment, i.e. line speed, feeding product, line clearances, loading or unloading materials.
  • Establish efficient processes, monitoring results, and improve identified process opportunities using Right First Time and Lean principles.
  • Enter data into PLS to ensure accurate, complete, and timely training documentation. Perform detailed inspection of commodities.
  • Work with unit leadership to develop action plans to close training gaps.
  • Develop solutions to routine problems following established Pfizer policies and procedures.
  • Prioritize own workflow and allocate work to others and assist in establishing their priorities.

ROLE RESPONSIBILITIES

  • Functions as the leader for the shop floor and coordinates daily activities to meet production schedule attainment.
  • Assists, trains and performs line duties as required in meeting production requirements. 
  • Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in efficiencies, material variances and product quality.
  • Under supervisor guidance, monitors training requirements and recommends training to assure employees perform jobs correctly. 
  • Follow all SOPs, cGMPs, batch records, TCPs, BOMs and POPs and remain current with all training requirements
  • Demonstrate and promote a “Right the First Time” culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner
  • If supervisor is not available, serves as point of contact for questions pertaining to line runnability, production schedule and/or batch documentation.    
  • Able to take on additional responsibilities as project and/or process improvement lead initiatives deemed appropriate by supervision
  • Serve as a mentor, and trainer for full-time and contracting Filling Operators in the area
  • Ensure batch related documentation and inventory transaction consumption are complete and accurate.
  • Responsible for ensuring all team members are always acting with appropriate Aseptic Behaviors while performing aseptic operations (i.e filling)
  • Aseptic Qualifications completed and maintained
  • Observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite and implement and identify needed improvements.
  • Provide immediate feedback during routine observation in an effort to develop colleague capabilities.
  • Evaluate aseptic processes during validation smoke studies
  • Oversees documentation within area of responsibilities following ALCOA principles.
  • Responsible for escalating personnel/behavior related issues as well as aseptic behavioral issues to supervision.
  • Maintain aseptic coaching techniques in compliance with all aseptic behaviors, SOPs, and Pfizer Site Policies.
  • Performs other duties as assigned by supervisor.
  • Ensures team members are always exhibiting appropriate Aseptic Behaviors while performing aseptic operations (i.e. filling)
  • Understands Core Processes (Filling) and able to perform core process tasks as needed depending on shop floor demands
  • Participates and serves as SME in support of area or regulatory audits (GMP/Maintain Audit readiness)
  • Ensure daily, weekly, & four-week cleanings are performed per applicable procedures
  • Supports cleaning and start-up activities as it pertains to shutdown. 

Qualifications

  • Must have a high school diploma or general education degree (GED) equivalent
  • A minimum 3-5 years prior related work experience and/or training 
  • Experience interacting with regulatory agencies is strongly preferred.
  • Effective Leadership Skills – Work with integrity, inspire others, and is accountable   
  • Must have basic math and reading comprehension skills; perform unskilled work and follow detailed instructions
  • Must be able to gown aseptically and retain certification.
  • Under the guidance of management, must be able to lead and direct others to ensure the work gets done and operational goals are met
  • Strong ability to multi task and project manage to an established timeline
  • Must be able to communicate effectively (written and verbal) with all line personnel to meet all operational goal
  • Exhibit behaviors that align with Pfizer values: Courage, Excellence, Equity and Joy
  • Must be self-motivated, able to work independently and have a problem-solving mindset

 
 

PHYSICAL/MENTAL REQUIREMENTS

  • The capability to aseptically gown
  • The capability to focus attention on the lines performance and adherence to aseptic behaviors and operational procedures that in turn leads to higher than normal performance.
  • Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance/actions
  • Knowledge of pharmaceutical manufacturing and regulatory compliance
  • Demonstrated aptitude to execute Aseptic techniques to a high degree of proficiency
  • Must be able to work in conditions with exposure to inks, solvents, heat, steam, solvents and most product solutions.
  • Must be able to read and write and follow written and oral instructions.
  • Must be able to communicate and work well interdepartmentally, as well as, with all plant departments.
  • Required to do frequent lifting of 15-20 pounds and occasional lifting in excess of 25 pounds.
  • Vision must be correctable to 20/20.
  • Satisfactory performance and attendance is required.
  • Must be capable of performing data entry into calculators and computers

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Eligible for Relocation Package: for NO

Eligible for Employee Referral Bonus: YES

  • This job is a US/PR Non-Exempt Grade: 00G

 

PHYSICAL/MENTAL REQUIREMENTS

PHYSICAL/MENTAL REQUIREMENTS

  • The capability to aseptically gown
  • The capability to focus attention on the lines performance and adherence to aseptic behaviors and operational procedures that in turn leads to higher than normal performance.
  • Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance/actions
  • Knowledge of pharmaceutical manufacturing and regulatory compliance
  • Demonstrated aptitude to execute Aseptic techniques to a high degree of proficiency
  • Must be able to work in conditions with exposure to inks, solvents, heat, steam, solvents and most product solutions.
  • Must be able to read and write and follow written and oral instructions.
  • Must be able to communicate and work well interdepartmentally, as well as, with all plant departments.
  • Required to do frequent lifting of 15-20 pounds and occasional lifting in excess of 25 pounds.
  • Vision must be correctable to 20/20.
  • Satisfactory performance and attendance is required.
  • Must be capable of performing data entry into calculators and computers

 

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

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



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.


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