Use Your Power for Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

The Shift Lead is responsible for supporting the Qualification, Validation through to commercial operation of a new isolator filling line for freeze dried drug products in a new purpose-built aseptic manufacturing facility. You will begin in the project phase as an integral member of the Operational Readiness team supporting development and implementation of aseptic processes and procedures. During the later parts of the project, you will transition to a Shift Lead role for daily operation supervision working in a controlled manufacturing environment.

• Working hours: This period will involve working Monday to Friday during daytime hours, with occasional late afternoon coverage.
• Equipment/Process Qualification: Act as an operations representative and Subject Matter Expert (SME) on specific equipment or processes. Support engineering team for the preparation and review of qualification protocols based on pre-defined User Requirement Specifications (URS), as well as supporting execution of Site Acceptance Test, Installation Qualification, and Operational Qualification activities.
• Quality and Compliance:
  • Support and develop operational risk assessments for equipment and manufacturing processes.
  • Develop Standard Operating Procedures (SOP) for manufacturing processes and operations of equipment and implement following the change control process.
  • Ensure process and procedures meet regulatory expectation and the line is operationally ready for commercial manufacture.

• Safety: Ensure that all safety protocols are followed, promoting a safe working environment. Conduct regular safety audits.

• Training: Manage training of production colleagues on new manufacturing processes and equipment maintaining accurate records.

• Working hours: This period will begin with a two-shift operation (day/afternoon) transitioning to a 24/7 schedule. The Shift Lead will ultimately supervise one of four 12-hour shifts (Dayshift: 6AM to 6PM, Night shift: 6PM to 6AM).

• Equipment/Process Qualification: Oversee machinability trials, Performance Qualification (PQ), and Aseptic Process Simulations ensuring the filling line is ready for commercial operations.
• Quality and Compliance: Monitor aseptic production processes to ensure that products meet stringent quality specifications and regulatory standards. Address any issues that arise using global quality systems and implement corrective actions as required.
• Safety: Ensure that all safety protocols are followed, promoting a safe working environment. Conduct regular safety audits.
• Training: Manage training and development of production colleagues on new manufacturing processes and equipment maintaining accurate records.
• Supervise Production Activities:
  • Lead and coach the operations team/shift during commercial operations, ensuring adherence to pre-defined Standard Operating Procedures (SOP).
  • Ensure Batch Records are prepared and completed in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Maintain accurate records of production activities, including output, downtime, and quality concerns.
  • Prepare and submit regular reports to the Production Lead.
• Continuous Improvement: Identify opportunities and support the implementation of process improvements and changes that enhance efficiency, reduce waste, and optimise production workflows.
• Collaboration: Work cross functionally with all departments to ensure efficient manufacturing and drug product supply.

• A minimum of a Bachelor of Science, Engineering, or a related field is preferred.
• In-depth understanding of manufacturing processes, quality standards, and regulatory requirements (e.g., TGA, FDA). Familiarity with sterilisation methods, component/container/equipment preparation processes, and FMEA risk assessment.
• Excellent leadership, communication and team management skills. Strong problem-solving abilities, and proficiency in using production management software and tools. Lean six sigma skills are an advantage.
• A working knowledge of Upstream/Downstream Current Good Manufacturing Practices (cGMP) manufacturing operations with a minimum of 3-5 years of experience in manufacturing, with at least 2 years in a supervisory role. Aseptic processing and isolator technology experience is desirable.
• Ability to work in a dynamic, fast-paced, and goal-driven environment.
• Strong decision-making capability.

• 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