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Microbiologist

Employer
Pfizer
Location
Kalamazoo, Michigan
Start date
Aug 5, 2022

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Discipline
Science/R&D, Biology, Research, Microbiology
Required Education
Associate Degree
Position Type
Full time
Hotbed
Best Places to Work
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Job Details

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. You will be responsible for sterilization validations to support our quality programs. Your contribution to sterilization system testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards.

As a 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 among limited 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

Successful candidate will be in the sterilization technology group and be assigned specific technologies to learn and eventually oversee multiple sterilization systems on the site that use those technologies. Candidate will be responsible for writing, executing, and then completing final report for each annual requalification of the individual systems that are under their responsibility.

Candidate will interact with other team members within the Microbiology Department and with team members from other departments, primarily within the Quality and Drug Product Operations organizations to ensure high-quality execution and completion of sterilization validation responsibilities. Will interface with many levels of the organization including Laboratory Technicians, Staff Microbiologists, Production Operators, Quality and Operations Management, and eventually internal and external Regulatory Auditors.

Candidate will also provide subject matter expertise for standard operating procedures and quality standards content, as well as provide gap analysis to ensure that these programs are compliant with all regulatory requirements.

Candidates will:

  • Perform periodic re-qualification of laboratory and production sterilization systems, interpret and evaluate data in terms of accuracy, precision, trends and potential GMP impact, and recommend appropriate corrective actions.
  • Meet with group to review performance of lab and production equipment, recommend improvements, and develop and implement changes to processes.
  • Act with others to drive continuous improvement within the team and across departments.
  • Provide subject matter expertise and oversight of the daily activities of technical level colleagues.
  • Train others in the theory and practice of one or more of sterilization technologies.
  • Independently write SOPs, technical reports, project plans, etc.
  • Apply existing techniques and procedures, with recommendations, and implement modifications for improved efficiency.
  • Need to be able to recognize atypical data, inform supervision of relevant problems, and implement solutions.
  • Contribute to the completion of specific team objectives and assigned project milestones.
  • Candidate will be required to complete aseptic gowning certification (Grade B) in order to enter aseptic manufacturing areas to place and retrieve biological indicators, participate in media fill observation, and function as smoke study observer.

Off-shift and weekend work will be required occasionally based on business needs.

Qualifications

Must-Have
  • Applicant must have 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.
  • Understanding of aseptic laboratory techniques is essential.
  • The successful candidate will have good planning skills, good oral and written communication skills, and a knowledge of fundamental microbiology principles.
  • Candidate should have experience with grade B aseptic gowning and behavior along with functioning as a media fill observer.
  • Candidate should be versed in autoclave usage with at least one year of experience with equipment and loads.
  • Must be able to work independently or with a team to complete performance qualificationsof new systems being installed on site.
  • Preferred candidates will display a technical knowledge of two or more of these microbiological disciplines: Experience with any type of sterilization system, aseptic processing experience, Biological indicator testing, Sanitization validation experience, or Container Closure Integrity Testing (CCIT).
  • Mechanical aptitude in order to disassemble equipment and place temperature measuring probes and biological indicators within large production systems.
  • Cannot be afraid of working with large production systems.
Nice-to-Have
  • Experience with autoclave, VHP, IHP, Gamma, EtO, SIP, continuous dry heat tunnels or batch dry heat sterilization system validation.
  • Experience using Lean, Six Sigma, and other continuous improvement methodologies for process improvement is highly desirable.


PHYSICAL/MENTAL REQUIREMENTS

Job duties can be physically demanding, including heavy lifting, spending hours on your feet, working at heights, and confined space entry.

Job duties can also be located in areas that are not temperature controlled and exposure to heat and or cold are possible.

Job duties may also involve sitting for extended periods while working at computer terminal.

Will be required to maintain aseptic gowning certification (Grade B) in order to enter aseptic manufacturing areas.

A mechanical aptitude is beneficial.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Job will require working off shift occasionally. Some travel may also be required. Must be able to maintain grade B aseptic gowning qualified.


Relocation support available

Work Location Assignment:Flexible

Last date to apply- 8/23/2022

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.

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

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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