Aseptic Production Lead

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. Here Is What You Need (Minimum Requirements) Must have a high school diploma or general education degree (GED) equivalent A minimum 3+ 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 Must be able to promote and operated within a positive team environment 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 Shifts Rotating 12 hours day, Rotating 12 hours nights, 12 hours day, vary Mon-Fri., or 12 hours nights, vary Mon-Fri. Last date to apply March 23, 2026 Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Manufacturing