Pfizer’s purpose `Breakthroughs that change patients’ lives’ fuels everything we do.  We innovate every day to help make the world a healthier place. From scientific discovery to breakthrough products to our essential partnerships around the world, we’re committed to quality healthcare for everyone. Because every individual matters. 

Why Patients Need You

At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.

What You Will Achieve

You will oversee and manage operational aspects of ongoing improvement projects, acting as a liaison between the project teams and the line management.  You will support our programs by managing the review of the status of the project, budget, schedules and preparing status reports. You will assess project issues and develop resolutions to meet productivity, quality and client satisfactions goals.

As a Project Coordinator, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

How You Will Achieve It

• Taking accountability for effective project management, oversight and delivery of multiple projects that support the product transfer.
• Liaise and collaborate with key stakeholders (Engineering, Capital Projects, Operations, Quality, Supply, Regulatory, EHS, Product Transfer) to ensure the programs dependencies are fully defined.
• Develop project plans to implement key initiatives and contribute to the completion of projects.
• Take ownership, show commitment to getting things done and willingness to see problem resolution through to completion.
• Lead complex, cross-functional projects which includes defining and implementing the vision for the project and goals with input from the project sponsor and project team members.
• Be open to other points of view, cordial and willing to accept feedback.
• Manage meetings and communications for teams to drive efficient decision making.
• Manage own time to meet agreed targets, develops plans for activities on own projects.

Qualifications

Must-Have

• Bachelor's Degree in science or engineering
• 5+ years of experience
• Knowledge and application of Good Manufacturing Practice and experience in dealing with Regulatory Authorities and Auditors.
• Experience working in the research and development of pharmaceutical industry
• Good project management skills, highly motivated, strong consultative, analytical, technical, problem solving, and interpersonal skills
• Excellent verbal and written communication skills
• Proficiency in MS Project, Excel, PowerPoint

Nice-to-Have

• Master's degree
• Work experience in Operations or Project management experience
• Working knowledge of System Application & Products

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.

  
Work Location Assignment: PGS Melbourne site

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.

Opportunities for Utilities, Facility, Equipment and Automation Validation for new filling line.

Construction of a new Facility is ongoing.

Equipment FAT is in final stages as the site prepares for SAT.

The filling line will use isolator technology with VHP.

There are exciting opportunities. We are currently seeking enthusiastic Validation Engineers ( 2 years fixed term ) with experience in:

• Facility Commissioning and Qualification/Validation
• Utility Qualification/Validation
• Equipment commissioning and Qualification/Validation
• Validation of Automated systems/CSV.

Please highlight in cover letter where your skills are most relevant.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective Engineering team. You will be responsible for evaluation, review and approval of validation master plan, protocols and reports. Your methodological approach will help us ensure compliance of our quality systems with company standards and government regulatory requirements. Your
problem-solving ability will help us troubleshoot validation problems for equipment and performance processes and conduct statistical analysis of testing results and process anomalies. Your documentation skills will guide the writing, review and approval of for qualification and validation documents and reports related to equipment, products and processes.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team and to drive improvements. Your focus and ability to meet team targets will help in completing critical deliverables. You will be expected to lead end to end execution of qualification of equipment and systems. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Provide high level data analysis support for Investigations and drive quality decisions.
• Comprehensive understanding of {Current} Good Manufacturing Practices {part of GxP} guidelines outlined in Code of Federal Regulations.
• Ensure compliance with latest Pfizer Quality Standards for validation and qualification activities.
• Manage routine Quality systems, such as Change Control, Document routing systems and and Investigations.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Maintain Site Validation Master Plan Support regulatory audits through the preparation, defense and interaction with auditors in areas related to equipment, instrumentation, facilities and utilities.
• Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, facilities and utilities.
• Assess potential impact of changes to qualified systems Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary.
• Support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility.
• Support product transfers/new product development, regulatory queries, cost improvement projects or Drug Product plant support.
• Ensure integration of validation and requalification schedule in production schedule for implementation of validation activities and conduct validation deviations, participate in deviation investigations to identify root causes and define corrective and/or preventative actions. Support the unit where needed to assure due dates and customer needs are met.

Qualifications

Must-Have

• Bachelor's Degree
• 3+ years' experience
• Experience in Qualification of equipment used for sterile filling
• Experience in Detailed Design review, URS development and qualification protocols generation for initial qualification of a new filling line
• Experience in {Current} Good Manufacturing Practices {part of GxP}
• Strong working knowledge of a variety of quality systems and processes
• Familiarity with information systems, such as Global Document Management System, System Application & Products and Quality Tracking System
• Ability to work in a team environment and manage projects independently
• Strong ability to drive projects ensuring -accountability for required tasks
• Strong planning and communication skills

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience.
• Experience in lyophilisation or strong interest and motivation to acquire the skills
• Experience with Siemens PCS7
• Experience with integration of automated systems with multiple equipment
• Design and validation of automated batch records
• Experience with IMA filling equipment
• Experience with isolator filling and VHP
• Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems is required, as related to sterile products and medical devices

 
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.