Environmental Monitoring Project Specialist – Microbiologist

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 analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility 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. You will also be relied on for setting requirements for the transfer of methodology from R&D.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

Role Summary

The primary function of the Environmental Monitoring Project Specialist – Microbiologist is to perform studies for test method development, validation and media usage qualifications. In addition, the role holder will complete environmental monitoring risk assessments, and update necessary document including but not limited to environmental monitoring sample rationale, sample plans, and SOPs.

The role holder must have experience working in a biological quality lab and have a granular understanding of aseptic manufacturing as well as a thorough understanding of micro-organisms, regulatory expectations and industry best practices necessary to support aseptic manufacturing.

ROLE RESPONSIBILITIES

• Complete test method validation studies and media qualification studies
• Perform growth promotion
• Manage environmental control projects
• Generate change controls for procedure updates
• Participates in functions involving teams which impact production, increase efficiency, solve problems, generate cost savings and improve quality. Ensures safety, housekeeping, and compliance are maintained.
• Provides support to investigations on site to help to identify root cause(s).
• Must be able to present work/studies to regulatory agencies with clarity, accuracy and simplicity while maintaining industry expectations and best practices

Qualifications

Must-Have

• 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.
• Requires experience working in a biological quality lab
• Requires knowledge/experience in aseptic technique/pharmaceutical industry/manufacturing.
• Requires strong oral, written, communication, presentation and interpersonal skills.
• Requires thorough knowledge of micro-organisms and good Lab practices.
• Must have experience in the development of microbiological testing methods and test execution, and associated documentation
• Need to be proficient in good laboratory techniques (i.e. pipetting, harvesting micro-organism, streaking colonies for isolation, etc)

Nice-To-Have

• Pharmaceutical manufacturing experience
• Environmental monitoring experience
• Project management experience

PHYSICAL/MENTAL REQUIREMENTS

Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.

Must be able to handle multiple projects at the same time.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be able to work on weekends, off shifts and holidays as the business demands.

Relocation support available

Work Location Assignment:On Premise

The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits tendersglobal.net (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control

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