Aseptic Production Lead

Pfizer•McPherson, KS

22h

About The Position

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 position is responsible for leading and organizing the shop floor to be align with daily operational needs. Clearly communicates supervisor's instructions and production schedules to employees in accomplishing a variety of tasks, in meeting quality, accountability, security, productivity and safety requirements per SOP's, batch records, CGMP's, and Plant Procedures. Reports quality, security, accountability and efficiency discrepancies and production progress to supervisor. Maintain aseptic coaching techniques in compliance with all aseptic behaviors, SOPs, and Pfizer Site Policies. Observe aseptic processing areas to continuously improve aseptic behaviors and techniques in the execution of production related activities. This individual will coach and provide feedback to aseptic personnel, aseptic quality and aseptic management to improve manufacturing processes. Perform work in strict compliance with manufacturing standards and all regulatory requirements, as well as strict adherence to safe work practices What You Will Achieve In this role you will: 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 Behaviours 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.

Requirements

Must have a high school diploma or general education degree (GED) equivalent
A minimum 3+ years prior related work experience and/or training
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
Must be able to promote and operated within a positive team environment
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

Nice To Haves

Experience interacting with regulatory agencies is strongly preferred.

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 Behaviours 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.