Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will Achieve
Provides technical support to Microbiological Services and Sterility Assurance by displaying technical experience in a variety of Aseptic Processing Principles (clean room environment), Aseptic Sampling, Disinfection, Sterilization, and Microbiology topics. Serves as a contributor to process deviation reporting, investigation and determination of root causes. Leads efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
Provides direction for microbiological requirements, aseptic processing principles, microbiological support for validation of new equipment and production areas, methods and sterilization processes and supports development for manufacturing operations.
Display technical experience in microbiology and aseptic techniques, principles, theories, concepts and industry practices/standards. Evaluates changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards. Writes evaluations to support Change Control Requests, ROIs, URS, etc. Also writes SOP’s, qualification protocols, technical reports, project plans, etc. Focuses on leading/participating in defined projects. Some hands-on laboratory work in the Microbiology laboratory or the Aseptic Processing Area will be required.
Works under general supervision, referring to policies and practices for guidance and follows established procedures. Operates within established HR policies and basic colleague relations guidelines. Contributes to the completion of specific team objectives and assigned project milestones. The successful candidate will be required to drive continuous improvement and maintain a state of regulatory audit readiness over these programs. Demonstrates knowledge and leadership principles.How You Will Achieve It
Responsible for execution of a portion of the microbiological and environmental monitoring programs by:
- Support investigation writing, review and approval for environmental monitoring events in relation to the Aseptic Processing Area.
- Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact and recommends appropriate corrective actions.
- Performs trend analysis of viable and non-viable environmental monitoring data in support of aseptic operations.
- Provides subject matter expertise and oversight of the daily activities of technical level colleagues, may train others in these practices and techniques.
- Independently writes SOP’s, technical reports, project plans, microbiological assessments, etc.
- Supports regulatory and/or vendor audits with understanding of EU and US regulatory requirements.
- Supports validation and qualification activities for aseptic processes
- Applies existing techniques and procedures, with recommendations, and implements modifications for improved efficiency.
- ·Applicant must have High School Diploma (or Equivalent) with six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience. Degree preference in Microbiology or related field with 3 years of experience supporting aseptic processes.
- Candidates will possess experience with microbiological disciplines: Aseptic Processing, Environmental Monitoring of a Pharmaceutical Cleanroom Environment (viable and non-viable), Aseptic Gowning.
- Experience utilizing Lean, Six Sigma and other continuous improvement methodologies for process improvement.
- Experience with lab equipment qualification.
Must not be allergic to Penicillin.
Job duties can be physically demanding. These duties include: moderate lifting, standing for long periods of time, sitting at a computer terminal and laboratory bench work. Candidate must be able to complete aseptic gowning training and be able to work gowned. Candidate will need to understand principles of scientific writing and design of experiments.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Night shift - Mon-Fri.11:00 p.m.-0730 am and occasional weekend work may be required, also modified hours are required at times to support production.
Work Location Assignment:On Premise
Last Date to Apply for Job: October 7, 2022
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.
Quality Assurance and Control