Aseptic Production Lead

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.

• 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