Senior Validation Engineer - Pharma Quality & Compliance

PFIZER INC; City of Monash; On-site; AUD 110,000 - 160,000; Full time

Benefits offered by this job

Paid parental leave

Health & Wellness apps

Career Growth Experiences program

Recognition & rewards program

Paid volunteer days

Life Insurance Benefits

Job summary

Pfizer Australia and New Zealand is seeking a skilled Validation Engineer to evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer Quality Standards. The role involves troubleshooting validation issues, conducting statistical analyses, and supporting regulatory audits.

Strong GMP knowledge and communication skills are essential. On-premise location with career growth and comprehensive Pfizer benefits package.

Qualifications

• Experience with GMP and quality systems.
• Excellent verbal and written communication skills.
• Ability to work independently and in a team environment.

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports
• Troubleshoot validation issues for equipment and processes
• Conduct statistical analysis of testing results and provide data analysis support for investigations
• Guide writing, review, and approval of validation documents and reports
• Maintain site Validation Master Plan and support regulatory audits

Skills

Quality systems knowledge

Good Manufacturing Practices

Statistical analysis

Communication skills

Team and independent work

Education

Bachelor's degree in a relevant field

Tools

Global Document Management System

System Applications & Products (SAP)

Quality Tracking System

Job description

Pfizer Australia and New Zealand is seeking a skilled Validation Engineer to evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with Pfizer Quality Standards. The role involves troubleshooting validation issues, conducting statistical analyses, and supporting regulatory audits.

Strong GMP knowledge and communication skills are essential. On-premise location with career growth and comprehensive Pfizer benefits package.