Pfizer Sr. Aseptic Process Engineer 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.
What You Will Achieve
Provide project leadership, technical expertise and operational support for Drug Product Operations and specifically the new Modular Aseptic Processing (MAP) MOD 2 facility.
This position will partner with the Pfizer Global Engineering MAP MOD2 Capital Project Team as an equipment Subject Matter Expert (SME) in the Prep & Formulation workstream.
Position will partner with OEM vendors, automation, engineering, verification and quality to ensure the equipment meets operational, quality and EHS requirements and integrates with the facility as well as upstream and downstream equipment.
The position will transition to an operations support role after regulatory approval. Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of products. Assists in equipment troubleshooting activities as needed.
How You Will Achieve It
Supports project through equipment design, facility integration, installation, start-up, qualification, process transfer, and transition to commercial production of a new aseptic filling suite. Responsible for technical development of junior colleagues.
Successful candidate must be familiar with tools and techniques required to manage large scale complex projects through multi-disciplinary teams.
Support capital project from an Operational Readiness standpoint to include: Verification and testing support, SOP development, training, IMEx deliverables.
Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
Conducts tests and measurements throughout stages of production to determine control over applicable variables.
Investigates deviations that occur on the manufacturing floor. Performs root-cause analysis 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.
Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
Provides concise and thorough updates on initiatives to site leadership.
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience
Pharmaceutical or manufacturing experience and strong, demonstrated project management skills exhibited in a cGMP environment are requirements.
- Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
Job will include standing, walking, and sitting. Occasional lifting may be required.
Aseptic gowning training may be required. Job may also require occasional weekend/evening work supporting a 24-hour/7-day operation.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Up to 25% domestic and/or international travel
Relocation support available
Work Location Assignment:On Premise
Other Job Details:
Last Date to Apply for Job: April 10, 2023
Eligible for Employee Referral Bonus
Relocation assistance may be available based on business needs and/or eligibility.
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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