Pfizer Vaccine Formulation Continuous Improvement Specialist in Kalamazoo, Michigan
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.
Provides technical expertise and operational support for the Vaccine Formulation Facility (VFF) Operations, with a focus upon production processes.
Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of human injectable products.
Lead standard work and continuous improvement initiatives across one, or multiple, work center areas including aseptic preparation, dispensing, lipid nanoparticle manufacturing, tangential flow filtration, and GMP facility support systems.
Identifies and help implement cost savings ideas, specifically line efficiency improvements and other projects that increase equipment capacity.
Analyze data from throughout different stages of production to determine control over applicable variables.
Own/facilitate the continuous improvement process by understanding the overall needs of the area and ensuring that the right projects are being escalated at the right time.
Analyze the output of standard work initiatives and propose changes to standard work based on the data. Propose and facilitate continuous improvement of standard work.
Conducts tests and measurements throughout stages of production to determine control over applicable variables.
Investigates deviations of medium complexity, involving multiple departments that occur on the manufacturing floor. Performs root-cause analysis utilizing Six Sigma tools, and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
Lead Operational Excellence initiatives (i.e. Kanban, M1 investigations, GB certification, etc.), develop OpEx skills of colleagues, and drive a culture of continuous improvement with their team.
Partner with shopfloor colleagues, leadership and enablers to ensure continuous improvement initiatives are identified and completed in a timely manner.
HS Diploma plus a minimum of 7 years of applicable technical experience or
BA/BS plus a minimum of 2 years experience, or
MS in a science or engineering related field.
Basic project management and presentation skills are required.
Basic financial skills and business acumen are required.
Two to three years related experience and/or training
Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
Pharmaceutical or manufacturing experience and strong, demonstrated technical skills exhibited in a cGMP environment are preferred. Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
Six Sigma Certification
Candidate will be required to gown and execute responsibilities according to departmental procedures.
Occasional lifting/lowering up to 55 pounds and reaching/standing/walking/stooping/crawling.
Able to wear safety PPE (Hard hat, body harness, face shield).
Able to work under clean room (GRADE C/D) environments with appropriate gowning.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Up to 5% domestic and/or international travel
This operation will work 24x7x365 covered by three 8-hour shifts: 1st Shift (0600-1400), 2nd Shift (1400-2200), 3rd Shift (2200-0600).
Weekend, holiday, and overtime work may be required to meet business and customer needs.
Relocation support available
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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