QA Validation Specialist III

Pfizer; United States; On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

Referral bonus

Relocation assistance (possible)

Job summary

Pfizer is seeking a Quality Assurance/Validation professional to oversee the validation program at the Andover, MA site. You will review validation docs, approve change controls, and support project teams on compliance issues to maintain the validated state.

Expect active participation in continuous improvement and readiness for inspections. The role requires strong knowledge of GMP, 21 CFR Parts 11/210/211, and experience with validation practices.

Qualifications

• Bachelor's degree with 4+ years of experience or higher education equivalents.
• Strong understanding of validation principles and regulatory guidelines.
• Experience with validation/regulatory compliance documentation.
• Proficiency in project management and resource planning.
• Independent decision-making with strong communication skills.
• Experience with computerized systems and software applications.

Responsibilities

• Oversee validation documentation review and approvals.
• Review/approve change controls and assess validation impact.
• Support project teams on compliance and technical validation issues.
• Review investigations, commitments, and procedures related to validation.
• Resolve quality validation issues and contribute to continuous improvement.
• Maintain inspection readiness and utilize enterprise systems.

Skills

Validation principles

Regulatory standards

Project management

Independent decision-making

Communication skills

Computerized systems

Education

Bachelor's degree + 4+ yrs

Master's degree + 2+ yrs

PhD + 0+ yrs

Associate's degree + 8 yrs

High school diploma + 10 yrs

Tools

Veeva (eQMS)

Pfizer Document Repositories

Pfizer Equipment Maintenance System

Job description

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

In this role, you will:

• 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

• 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 ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws a