Validation Engineer

Pfizer; Town of Middleton (WI); On-site; USD 69,000 - 114,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching

Pfizer Retirement Savings Contribution

Paid vacation

Paid holidays

Personal days

Medical, dental and vision benefits

Job summary

Pfizer in Wisconsin seeks a detail-oriented validation professional to support qualification, validation, and compliance activities in a regulated manufacturing environment. You will execute protocols, analyze data, and prepare technical reports to ensure equipment, processes, and systems meet regulatory standards.

You will collaborate with cross-functional teams, lead or contribute to validation projects, assist investigations and risk assessments, and help maintain cGMP compliance while

Qualifications

• Bachelor's degree with any years of experience, or Associate's degree with 4+ years of relevant experience, or high school diploma with 6+ years of relevant experience.
• Strong knowledge of FDA regulations/Guidance and Good Manufacturing Practices (cGMP).
• Excellent organizational skills and ability to meet changing deadlines.
• Proficiency in Excel for data evaluation and reporting.
• Strong written and verbal communication and teamwork.
• Basic understanding of validation principles and practices.

Responsibilities

• Evaluate and review validation protocols, periodic reviews, and reports for regulatory compliance.
• Troubleshoot validation problems using statistical analysis of test results.
• Draft and review validation documents, technical reports, and risk assessments.
• Lead or contribute to validation projects and milestones with the team.
• Assist with investigations, deviations, and CAPA to identify root causes and corrective actions.
• Adhere to cGMP procedures and safety regulations while supporting continuous improvement.

Skills

Data analysis

Regulatory compliance

Attention to detail

Team collaboration

cGMP knowledge

Problem solving

Education

Bachelor's degree with any years of experience

Associate's degree with 4 years of relevant experience

High school diploma with 6 years of relevant experience

Tools

Excel

Microsoft Office

Statistical analysis software

Job description

Use Your Power for Purpose

We are seeking a detail-oriented and motivated validation professional to support qualification, validation, and compliance activities in a regulated manufacturing environment. In this role, you will help ensure equipment, processes, and systems meet regulatory requirements and company standards through protocol execution, technical documentation, data analysis, and problem-solving. Working collaboratively with cross-functional teams, you will contribute to validation projects, support investigations and risk assessments, and play a key role in maintaining compliance with current Good Manufacturing Practices (cGMP) while driving continuous improvement.

What You Will Achieve In this role, you will:

• Evaluate and review protocols, periodic reviews and reports, ensuring compliance with regulatory requirements and company policies.
• Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies.
• Write and review validation process documents and technical reports or risk assessments related to equipment, products, and processes.
• Contribute to or lead project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
• Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues.
• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.
• Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records.
• Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions.
• Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
• Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices.
• Strong organizational skills and the ability to manage changing deadlines.
• Proficiency in Microsoft Office, particularly Excel, for data evaluation.
• Strong written and verbal communication skills.
• Ability to work in a team environment and collaborate effectively with colleagues.
• Basic understanding of validation principles and practices.

Bonus Points If You Have (Preferred Requirements)

• Technical writing experience, particularly within the pharmaceutical industry.
• Working knowledge of equipment qualification and calibration.
• Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams.
• Adaptability and flexibility in a dynamic work environment.
• Commitment to continuous learning and professional development.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

PHYSICAL/MENTAL REQUIREMENTS

• Physical Demands: Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.
• Work Environment: Office environment, with frequent time in manufacturing.
• NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS: Colleague must be willing to work off-hours when project or production demands require it.

Other Job Details

• Last day to Apply: September 17, 2026.
• Work Location Assignment: On Premise.
• The annual base salary for this position ranges from $68,600.00 to $114,300.00. 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.
• 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

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.