Job Description

ROLE SUMMARY

The Pfizer Sanford site is a complex multi-product, multi-host biotech manufacturing site that manufactures clinical and commercial Vaccine and Gene Therapy products. The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality activities associated with Microbial Control of the Sanford facility. Key responsibilities are supporting investigations, reporting on microflora present in the facility, and developing and driving implementation of continuous improvement activities associated with contamination and environmental control. In addition, support for regulatory agency inspections will be required. Key responsibilities are performing GMP tasks associated with maintaining compliant manufacturing areas and operations through sampling, analyzing, interpreting and trending results.

The individual should be able to demonstrate the following:

* Act safely, know, and follow all EH&S safety requirements for site
* Display knowledge in cGXP, Microbial Control, Environmental Monitoring, and Data Analysis
* Has a good foundation in general scientific practice and in the principles and concepts of Microbiology
* Excellent written and verbal communication and interpersonal skills
* Ability to organize self and track status of assigned actions across multiple production areas
* Organizes and provides written and/or oral presentations of work with minimal input.
* Ability to follow written procedures and learn from hands on training
* Participates in activities/projects to support work group/project team goals
* Author SOPs, forms, protocols, investigations, and risk assessments (facilitator and/or team member).

ROLE RESPONSIBILITIES

* Has strong knowledge/understanding of the principles and concepts of microbiology and impact of microbes in industrial processes
* Contributes to the development and execution of Microbial Control site strategy by providing technical support for complex projects in order to ensure compliance to the strategy as well as PQS and BOH requirements
* Drives implementation of site strategy initiatives and works collaboratively to enforce aseptic behaviors and techniques across site
* Provides technical expertise related to aseptic techniques, contamination control strategy, environmental monitoring program, and other areas related to the influence of microorganisms on site manufacturing processes
* Prepares reports and/or exercises administrative control in support of the company's Microbial Control program
* Leads the completion of complex projects and assessments
* Acts as designee for Microbial Control Site Strategist
* Aseptic Behavior Program Coach (including conducting observations and ensuring adherence to aseptic behavior expectations.
* Conduct Aseptic Behavior training, guidance, and coaching as needed.
* Support media fill program strategy and airflow visualization review.

BASIC QUALIFICATIONS

* High school/GED required.
* 5 - 7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry required.
* A BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry is preferred; however, other appropriate combinations of education and/or experience in the biotech or pharmaceutical industry are suitable.

PREFERRED QUALIFICATIONS

* Preferred extensive knowledge of basic microbiology, aseptic practices, environmental and utilities monitoring and Quality Risk Management
* Experience with Global Quality Tracking System (TrackWiseTM application); Laboratory Information Management System (LIMS), Microsoft Office applications, specifically Word, PowerPoint and Excel

PHYSICAL/MENTAL REQUIREMENTS

Requires working in an office setting where sitting and computer usage would be typical. Ability to stand for at least 2 to 3 hours at a time, sit for at least 2 to 3 hours at a time, and walk long distances.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Limited weekend work may be required.

Limited travel for the position; no more than 10% traveling.

Other Job Details:

* Last Date to Apply for Job: April 22, 2021
* Eligible for Relocation Package: Yes
* Eligible for Employee Referral Bonus: Yes

LI-PFE

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 providers 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

LI-PFE