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Associate Validation Engineer

Company: Pfizer Inc.
Location: Rocky Mount
Posted on: November 9, 2019

Job Description:

ROLE SUMMARY
As an Associate Validation Engineer you will be responsible for validating/qualifying the systems used to develop and/or manufacture products within a large manufacturing facility located in North Carolina, USA. You will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

ROLE RESPONSIBILITIES

  • Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
  • Coordinates and communicates all testing with affected functional groups and evaluates test results.
  • Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
  • Participates and presents data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.
  • Understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation, such as, but not limited to GAMP 5 and ASTM E2500.
  • Perform Electronic Record/Electronic Signature (ERES) Assessments.
  • Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
  • Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
  • Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
    BASIC QUALIFICATIONS
    • BS/BA degree in science, engineering, manufacturing technology or closely related field is required
    • Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results
    • Strong conflict resolution skills
    • Must be able to interact with varying levels within the company
    • Must be able to work multiple shifts as needed to meet deadlines
      PREFERRED QUALIFICATIONS
      • Relevant experience or Internship / Co-Op experience in pharmaceutical, engineering, or manufacturing industries highly preferred
      • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices is preferred
      • Some technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices is preferred
        PHYSICAL/MENTAL REQUIREMENTS
        • Must be able to lift and carry light loads as necessary in conducting testing. Weekend or long hours based on testing schedule.
        • May involve standing for long periods of time.
        • Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.
          NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
          • Primary work schedule is Day shift, Monday - Friday but evenings and weekends will be required, as needed. Some travel,
            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.

            Other Job Details:
            • Last Date to Apply for Job: 11/12/2019
            • 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 , Associate Validation Engineer, Engineering , Rocky Mount, North Carolina

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