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The Role
Evaluates, executes, reviews, and approves pharmaceutical validation plans, protocols, and reports. Troubleshoots equipment and process validation issues, performs statistical analysis, manages quality systems, supports audits and investigations, and maintains the Site Validation Master Plan. The role also contributes to product transfers, new product development, cleaning validation, regulatory queries, and process improvement projects while coordinating cross-functional testing and documentation.
Summary Generated by Built In
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:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:
*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
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, execute, 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
Skills Required
- High school diploma or equivalent with 8 or more years of relevant experience, or associate degree with 6 or more years, or bachelor's degree with 2 or more years, or MBA/MS with any relevant experience
- Proven expertise in Good Manufacturing Practices
- Strong working knowledge of quality systems and processes
- Familiarity with Global Document Management System, SAP, and Quality Tracking System
- Excellent verbal and written communication skills
- Ability to work independently and in a team environment
- Technical knowledge of validation or qualification for pharmaceutical processes, equipment, utilities, facilities, 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 colleagues
- Experience with regulatory audits and compliance
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, with understanding of responsible AI practices
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
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Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
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Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.
Pfizer Insights
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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