Aseptic Production Lead

Pfizer • McPherson, KS

1d • $23 - $39 • Onsite

About The Position

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 such 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.

Requirements

• Must have a high school diploma or general education degree (GED) equivalent.
• 3+ years of production, manufacturing, or operations related experience.
• Completed or willing to complete Certified Trainer course.
• 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.
• Experience multi-tasking and managing projects with an established timeline.
• Must be able to communicate effectively (written and verbal) with all line personnel to meet all operational goals.
• Exhibit behaviors that align with Pfizer values: Courage, Excellence, Equity and Joy.
• Must be able to promote and operate within a positive team environment.
• The capability to aseptically gown.
• The capability to focus attention on the line's 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 are required.
• Must be capable of performing data entry into calculators and computers.
• This position requires permanent work authorization in the United States.

Nice To Haves

• Experience interacting with regulatory agencies is strongly preferred.
• A bachelor's degree.
• Experience in pharmaceutical manufacturing or a related field.
• Strong technical skills and the ability to troubleshoot equipment issues.
• Excellent communication and interpersonal skills.
• Ability to work in a fast-paced, dynamic environment.
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity.

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.
• 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.
• Serves as point of contact for questions pertaining to line runnability, production schedule and/or batch documentation when supervisor is not available.
• Takes on additional responsibilities such as project and/or process improvement lead initiatives.
• Serves as a mentor and trainer for full-time and contracting Filling Operators.
• Ensures batch related documentation and inventory transaction consumption are complete and accurate.
• Ensures all team members are always acting with appropriate Aseptic Behaviors while performing aseptic operations (i.e. filling).
• Observes and reviews aseptic practices on the manufacturing floor and implements and identifies needed improvements.
• Provides immediate feedback during routine observation in an effort to develop colleague capabilities.
• Evaluates aseptic processes during validation smoke studies.
• Oversees documentation within area of responsibilities following ALCOA principles.
• Escalates personnel/behavior related issues as well as aseptic behavioral issues to supervision.
• Maintains aseptic coaching techniques in compliance with all aseptic behaviors, SOPs, and Pfizer Site Policies.
• Performs other duties as assigned by supervisor.
• 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).
• Ensures daily, weekly, & four-week cleanings are performed per applicable procedures.
• Supports cleaning and start-up activities as it pertains to shutdown.

Benefits

• Eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.
• 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.
• Health benefits to include medical, prescription drug, dental and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED