Pharma Validation Engineer - CGMP & Compliance

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

Benefits offered by this job

401(k) with Pfizer Matching

Health benefits

Paid vacation & leave

Job summary

Pfizer is seeking a detail-oriented validation professional to support qualification, validation, and compliance activities in a regulated manufacturing environment. You will execute protocols, analyze data, and contribute to cross-functional validation projects while maintaining cGMP standards.

The role emphasizes collaboration, problem-solving, and documentation quality, with responsibilities spanning risk assessments, investigations, and process improvements in a manufacturing setting.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Experience with FDA regulations and cGMP requirements is essential.
• Strong organizational skills and ability to manage changing deadlines.
• Proficiency in Microsoft Excel and data evaluation.
• Clear written and verbal communication and teamwork.

Responsibilities

• Evaluate and review protocols, periodic reviews and reports for regulatory compliance.
• Troubleshoot validation problems for equipment and processes; perform statistical analyses.
• Write and review validation protocols, reports, and risk assessments.
• Lead or contribute to project tasks and milestones to meet deadlines.
• Assist with deviation investigations to identify root causes and corrective actions.
• Ensure compliance with cGMP procedures and safety regulations.

Skills

Attention to detail

FDA regulations

GMP knowledge

Excel proficiency

Written & verbal communication

Team collaboration

Education

Bachelor's degree or higher

Associate's degree + 4 years experience

High school diploma + 6 years experience

Tools

Microsoft Office

Job description

Pfizer is seeking a detail-oriented validation professional to support qualification, validation, and compliance activities in a regulated manufacturing environment. You will execute protocols, analyze data, and contribute to cross-functional validation projects while maintaining cGMP standards.

The role emphasizes collaboration, problem-solving, and documentation quality, with responsibilities spanning risk assessments, investigations, and process improvements in a manufacturing setting.