Pfizer

Senior Associate Process Validation (Secondment - 6 Months)

United States - North Carolina - Sanford Full time

WHY PATIENTS NEED YOU

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.

WHAT YOU WILL ACHIEVE

In this role, you will:

  • Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.

  • Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.

  • Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.

  • Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.

  • Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.

  • Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.

  • Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.

  • Support product transfers, new product development, regulatory queries, cost improvement projects, and Process Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

QUALIFICATIONS

Must-Have

  • Applicant must have a bachelor's degree with at least 3 years of experience; OR a master's degree with more than 1 year of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.

  • Proven expertise in Good Manufacturing Practices.

  • Strong working knowledge of various quality systems and processes.

  • Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.

  • Excellent verbal and written communication skills.

  • Ability to work independently and in a team environment.

Nice-to-Have

  • Strong technical knowledge with validation/qualification of pharmaceutical processes.

  • Experience with sterile products.

  • Strong analytical and problem-solving skills.

  • Strong organizational and time management skills.

  • Ability to mentor and guide other colleagues.

  • Experience in regulatory audits and compliance.

  

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Role may require occasional off shift or weekend work during validation projects.

OTHER JOB DETAILS

  • Last Date to Apply for Job: November 14, 2025

  • Additional Location Information: NO

  • Eligible for Relocation Package – NO

  • Secondment 6 months

  • If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

  • There will be no change to your current work location.

  • Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control