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Aseptic Process Engineer

Company: Pfizer Inc.
Location: Rocky Mount
Posted on: November 3, 2019

Job Description:

ROLE SUMMARY
The primary function of this position is to support the aseptic manufacturing areas. The Aseptic Process Engineer is responsible for the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: PQS review/implementation, shut down/restart process, Aseptic Review Board, media fill planning and oversight, investigations, smoke studies, aseptic technique evaluation, sanitation and change management. This candidate must be able to work cross functionally with BQ, Operation, Maintenance, Validation and MQ to deliver key milestones for projects.

ROLE RESPONSIBILITIES

  • Perform necessary assessments of aseptic operation and update necessary documents.
  • Able to present media fill, smoke study and sanitation programs to auditors.
  • Accumulates key metrics for presentation to Management team, including gowning and aseptic technique observation.
  • Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
  • Liaise with manufacturing, BQ, maintenance and aseptic trainers to appropriately schedule media fills and other work impacting the manufacturing areas.
  • Ability to be self-directed in the position and possess an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.
    BASIC QUALIFICATIONS
    • Bachelor's Degree in a technical/science field, such as Engineering, Chemistry, or Biology, is required.
    • Manufacturing experience is required, 2 years of aseptic manufacturing experience is preferred.
    • GMP knowledge is required.
    • Requires strong oral, written, communication, presentation and interpersonal skills.
    • Requires ability to handle multiple projects in a dynamic environment.
      PREFERRED QUALIFICATIONS
      • Master's Degree in a technical field is preferred.
        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.
          NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
          • Must be able to work on weekends, off shifts and holidays as the business demands.
            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.

            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.

            OTHER JOB DETAILS
            • Last date to apply: 11/3/2019
            • Additional Location Information: Rocky Mount, NC
            • Eligible for Relocation Package
            • Eligible for Employee Referral Bonus
              Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Keywords: Pfizer Inc., Rocky Mount , Aseptic Process Engineer, Engineering , Rocky Mount, North Carolina

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