Senior Validation Engineer — Pharma Quality & Compliance

Pfizer; Rochester (MI); Sur place; USD 83 000 - 138 000; Plein temps

Avantages offerts par ce poste

401(k) plan with Pfizer Matching

Pfizer Retirement Savings Contribution

Paid vacation, holidays and personal/m

Health benefits

Résumé du poste

Pfizer is seeking a validation professional to evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with Pfizer standards. The role includes troubleshooting validation issues, data analysis for quality investigations, and guiding the creation of validation documents.

You will manage quality systems and coordinate testing with cross-functional teams, supporting product transfers and regulatory inquiries while contributing to site audits and ongoing

Qualifications

• Minimum requirements include GMP knowledge and experience with quality systems.
• Strong verbal and written communication skills.
• Ability to work independently and in a team.

Responsabilités

• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
• Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
• Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
• Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
• Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
• Support regulatory audits and represent engineering validation on site or network teams.

Connaissances

GMP knowledge

Quality systems

Communication skills

Independent and teamwork

Formation

High school diploma

Associate degree

BA/BS

MBA/MS

Outils

Global Document Management System

System Applications & Products

Quality Tracking System

Description du poste

Pfizer is seeking a validation professional to evaluate, review, and approve validation master plans, protocols, and reports to ensure compliance with Pfizer standards. The role includes troubleshooting validation issues, data analysis for quality investigations, and guiding the creation of validation documents.

You will manage quality systems and coordinate testing with cross-functional teams, supporting product transfers and regulatory inquiries while contributing to site audits and ongoing