Senior QA Validation Specialist（12 months Fixed Term）

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

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.

What You Will Achieve

In this role, you will:

• 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.
• Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
• Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
• Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
• Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Proven expertise in Good Manufacturing Practices
• Strong working knowledge of various quality systems and processes
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
• Excellent verbal and written communication skills
• Ability to work independently and in a team environment

Bonus Points If You Have (Preferred Requirements)

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
• Experience with sterile products and medical devices
• Strong analytical and problem-solving skills
• Strong organizational and time management skills
• Ability to mentor and guide other colleagues
• Experience in regulatory audits and compliance
• 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

Work Location Assignment: On Premise

At Pfizer we care about our colleagues’ wellbeing and offer a range of great benefits for them, including:

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.

Pfizer Australia and New Zealand’s diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.

If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.

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