Pharma Validation Engineer — Compliance & Process QA

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

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