QA Validation Specialist III

Pfizer Inc.; Massachusetts; Vor Ort; USD 33.000 - 138.000; Vollzeit

Benefits dieser Stelle

Referral bonus eligibility

Zusammenfassung

Pfizer Inc. seeks a Quality Assurance/Validation professional to oversee the validation program at the Andover, MA site. You will review specifications, protocols, testing documents and change controls to ensure validated state and compliance with regulations.

The role requires strong validation knowledge, project management skills, and the ability to work independently in a regulated environment. Excellent communication is essential, with experience using Veeva and Pfizer systems a plus.

Qualifikationen

• Bachelor's degree with at least 4 years of experience; OR a master's with at least 2 years; OR a PhD with 0+ years; OR associate's with 8 years; OR high school plus 10 years of relevant experience.
• Strong understanding of validation principles and practices.
• Experience with regulatory requirements and guidelines for validation.
• Proficiency in project management and resource planning.
• Ability to work independently and make decisions in ambiguous situations.
• Excellent communication and interpersonal skills.
• Proficiency in computerized systems and software applications.

Aufgaben

• Provide QA oversight for the validation program at the Andover, MA Pfizer site.
• Review and approve validation documentation, including specifications and protocols.
• Review and approve change controls for validation impact and testing needs.
• Support project teams on compliance and technical validation issues.
• Review investigations, commitments, and procedures related to validation.
• Maintain readiness for inspections and participate in continuous improvement initiatives.

Kenntnisse

Validation principles

Regulatory requirements

Project management

Independent decision-making

Communication

Computerized systems

Ausbildung

Bachelor's degree or higher

Master's or PhD alternative experience

Tools

Veeva (eQMS)

Pfizer Document Repositories

Pfizer Equipment Maintenance System

Jobbeschreibung

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.

What You Will Achieve

• Serve as Quality Assurance oversight for the validation program at the Andover, MA Pfizer site.
• Primary focus on validation documentation review and approval including specifications, protocols, other testing documents, summary reports, higher level validation plans, program documentation and strategies.
• Review and approval of change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
• Provide support to project teams on compliance and technical issues related to validation to ensure compliance with company policies and government regulations.
• Review and approve investigations, commitments, and procedures, and maintenance work orders as they relate to validation.
• Exercises judgement in resolving simple to moderate quality validation issues.
• Participate in continuous improvement initiatives.
• Maintain a constant state is inspection readiness.
• Skilled in the use of Enterprise systems including, but not limited to Veeva (eQMS), Pfizer Document Repositories, Pfizer Equipment Maintenance System.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
• Strong understanding of validation principles and practices
• Experience with regulatory requirements and guidelines for validation
• Proficiency in project management and resource planning
• Ability to work independently and make decisions in ambiguous situations
• Excellent communication and interpersonal skills
• Proficiency in computerized systems and software applications

Bonus Points If You Have (Preferred Requirements)

• Comprehensive knowledge of GMP regulations and guidance, including 21 CFR Parts 11, 210 & 211, EC Annex 15, and ICH 7
• Strong background in problem-solving, negotiations, and data integrity principles
• Experience in project management/support within a matrixed reporting environment
• Good understanding of risk management methodologies and their application to Bio-pharmaceutical operations
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance daily work and organization.
• Technical writing experience
• Proven relevant industry experience in either Quality Assurance or Validation engineering.
• Combined experience in Quality Assurance or Validation Engineering / Engineering / Manufacturing / Laboratories preferred.

PHYSICAL/MENTAL REQUIREMENTS

none

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Typically, a standard Monday through Friday work schedule, office setting, little to no travel required. Minimal off shift support needed if issues arise.

OTHER JOB DETAILS

Last Date to Apply for Job: October 19, 2026.

Referral Bonus Eligibility: YES

Eligible for Relocation Package: NO

The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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 [e-mail] . 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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .

Quality Assurance and Control