Senior Microbiologist

Kalamazoo County, Michigan, US
Jul 26, 2021
Aug 11, 2021
Project Management
Employment Type
Full time
Salary Type
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
You will be a member of Pfizer's dedicated and highly effective quality assurance and control team.The successful candidate will provide microbiological subject-matter expertise within the department, and drive continuous improvement initiatives in support of viable and non-viable monitoring in classified environments as well as support associated laboratory operations. The successful candidate will be part of a specialized dynamic team that interacts with multiple levels and departments throughout the organization to drive change and ensure the high quality and continued supply of life-saving pharmaceuticals to the market.Your contribution to classified area environmental monitoring, utility monitoring (compressed gas/clean steam), microbiological deviation investigation, and microbial identification and trending will help Pfizer provide safe drugs to patients.
As a Senior Microbiologist, your significant experience of applying knowledge of principles, concepts, and practices of the discipline will make you a critical member of the team. Your skill and knowledge will help in making decisions that require choosing amongmultiple options. Your being proactive in team discussions will help in creating an environment of collaboration.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- The successful candidate will be a subject matter expert on the laboratory operations needed to support viable and non-viable environmental monitoring in a highly regulated and controlled GMP manufacturing environment.
- The successful candidate will assist in the overall operation of the laboratory including: review and approval of environmental monitoring results, submission of microbial isolates for identification, continuous improvement of current processes and methods, assisting with daily/weekly scheduling of laboratory technicians and contractors, overseeing qualification of new laboratory equipment and/or new or established manufacturing facilities, ordering lab supplies, evaluation of testing and lab practices against regulatory standards to ensure continued compliance, completing deviation investigations and corrective action/preventative action creation and execution, and creation and revision of standard operating procedures.
- The candidate will be responsible for individual contributions to achieve team deliverables. May perform work independently, or as an integral member of a team. Will contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Interacts with other team members in the laboratory, within the Microbiology department, and with colleagues from other departments (Operations, Quality, Maintenance/Engineering, and Regulatory
- Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.
- Serve on cross functional teams to represent Microbiology/Quality Control and facilitate communications and activities/projects between Microbiology/Quality Control and site departments and/or Network.
- Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
- Perform tasks associated with maintaining current Good Manufacturing Practices compliant Microbiology/Quality Control laboratories.
- Able to create and complete validation protocols and reports and equipment qualification/computer validation records.
- Train junior colleagues and develop training plans and oversee training activities for groups
- Write Standard Operating Procedures, process qualification documents, technical reports, project plans and other documents independently.
- Bachelor's of Science Degree in Microbiology, Immunology, Molecular Biology or other related specialized biological science.
- 4+ years of experience in a similar role within the Pharmaceutical and/or Bio-Pharmaceutical Industry (or comparable GLP/GMP Laboratory setting).
- Excellent oral, written and interpersonal communication skills.
- Knowledge and skills within Microsoft Office Suite. Comfort and familiarity with computer-based applications in a lab-oriented environment.
- A demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task), and be able to meet objectives in a flexible, team-oriented environment.
- A passion for continuous improvement, excellent project management skills, and experience driving critical projects to completion within agreed upon timelines.
- Understanding of aseptic laboratory techniques and quality systems
- In-depth knowledge of viable and non-viable environmental monitoring during pharmaceutical manufacturing and understanding of aseptic technique.
- Experience in Quality Operations
- Participation as single-point of contact for microbiological issues on high-profile capital projects.
- Experience defending laboratory practices in regulatory audits is preferred.
- Experience leading continuous improvement projects is a plus.
- Ability to analyze complex microbiological data, and recognize out-of-limits data and microbiological trends data, is required.
- Ability to utilize computer-based programs in both office and production environments.
- Long periods of standing, walking, and/or sitting may be needed.
- Occasional lifting (less than 35 lbs), and reaching may be required. Extended time working at a computer terminal is also required.
- Ability to maintain aseptic gowning qualification and be physically capable of entering aseptic clean room areas is required.
Off-shift, Weekend, and/or Holiday hours may be required in order to meet business and/or customer needs.
Occasional travel may be required ( Other Job Details:
- Last Date to Apply for Job: August 06 2021
- Eligible for Relocation Assistance: Yes
- Eligible for Employee Referral Bonus: Yes
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.
Quality Assurance and Control