Aseptic Production Lead

Use Your Power for Purpose

Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on 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 strive to improve outcomes. You will help ensure that patients and physicians have the medicines they need when they need them.

What You Will Achieve

• 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.

Here Is What You Need (Minimum 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. · 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.

• Experience multi-taking and managing project with 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 able to promote and operate within a positive team environment.

Bonus Points If You Have (Preferred Requirements):

• A bachelor's degree

• Experience in pharmaceutical manufacturing or a related field

• Strong technical skills and the ability to troubleshoot