• Job Description

  Req#: 4902484

  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 Validation team. You will be responsible for the creation, review and approval of validation master plan, SOPs, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of validation process documents and technical reports related to equipment, facilities, utilities, computer systems, products and processes.

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

  How You Will Achieve It

  • Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.

  • Coordinates and communicates all testing with affected functional groups and evaluates test results.

  • Executes validation activities to include Change Control initiation, protocol preparation, scheduling, protocol execution, data review and final report generation.

  • Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.

  • Participate in development/ improvements to the validation program as needed to remain current with cGMPs and industry standards.

  • Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.

  • Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).

  Qualifications

  Must-Have

  • Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+years of experience.

  • Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices

  • Some knowledge and experience with equipment, facility, utility or computer system validation, as related to sterile products and medical devices preferred

  • Must be proactive, have experience with high performance teams, strong interpersonal and project management skills

  • Must be able to interact with varying levels within the company

  • 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 work multiple shifts as needed to meet deadlines

  Nice-to-Have

  • Technical writing experience

  • Experience with pharmaceutical industry validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices

  • Working knowledge of Food and Drug Administration Regulations/Guidance, and Good Manufacturing Practices

  • Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results

  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.

  • able to manage multiple tasks at once.

  • 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, weekends and holiday work may be required, as needed. Some travel, <>

  OTHER JOB DETAILS

  Last Date to Apply for Job: February 11th, 2024

  Eligible for Relocation Package: NO

  The annual base salary for this position ranges from $54,700.00 to $91,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% 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 | (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

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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