Manufacturing Associate Night - Aseptic Isolator Manufacturing

Manufacturing Associate (Night) - Aseptic Isolator Manufacturing
We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer's purpose - Breakthroughs that change patients' lives - we have established a clear set of expectations regarding 'what' we need to achieve for patients and 'how' we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Transforming Delivery of high quality products
PGS - Manufacture the Future
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.
Job Summary:

Reporting to Shift Lead, the Manufacturing Associate is 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 the Manufacturing Associate role supporting daily operation supervision working in a controlled manufacturing environment.
What You Will Achieve:

Phase One:
Operational Readiness Team

Working hours:
This period will involve working Monday to Friday during daytime hours, with occasional late afternoon coverage.
Equipment/Process Qualification:
Reporting directly to the Shift Lead, you will assist as an operations representative and gain knowledge to become an operations Subject Matter Expert (SME) on specific equipment or processes. You will support the engineering team execute Site Acceptance Testing (SAT), Installation Qualification (IQ), and Operational Qualification (OQ) activities.
Quality and Compliance:


Support the development of operational risk assessments for equipment and manufacturing processes.
Assist in developing Standard Operating Procedures (SOP) for manufacturing processes and operations of equipment.
Ensure processes and procedures are operationally ready for commercial manufacture.

Safety:
Ensure that all safety protocols are followed, promoting a safe working environment.
Training:
Train production colleagues on new manufacturing processes and equipment, maintaining accurate records.

Phase Two:
Daily Operation Support (Mid 2025 to Early 2026)

This period will begin with a two-shift operation (day/afternoon) transitioning to a 24/7 schedule. The Manufacturing Associate will ultimately assist in managing one of four 12-hour shifts (Dayshift:
6AM to 6PM, Night shift:
6PM to 6AM).
Participate in machinability trials, Performance Qualification (PQ), and Aseptic Process Simulations ensuring the filling line is ready for commercial operations.
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.
Ensure that all safety protocols are followed, promoting a safe working environment. Conduct regular safety audits.
Support Production Activities:


Supervise operators and workflow during 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.
Step up and take on additional responsibilities in the absence of the Shift Lead.
Prepare and submit regular reports to the Shift Lead and wider team.

Continuous Improvement:
Identify opportunities and support the implementation of process improvements and changes that enhance efficiency, reduce waste, and optimize production workflows.
Collaboration:
Work cross-functionally with all departments to ensure efficient manufacturing and drug product supply.

Here Is What You Need:


A minimum of a technical certification or associate degree is preferred.
Understanding of manufacturing processes, quality standards, and regulatory requirements (e.g., TGA, FDA). Familiarity with sterilisation methods, component/equipment preparation processes, and FMEA risk assessment is an advantage.
Good communication and team collaboration skills. Strong problem-solving abilities, and proficiency in using common software.
A working knowledge of Upstream/Downstream Current Good Manufacturing Practices (cGMP) manufacturing operations with a minimum of 1-2 years of experience in manufacturing. Aseptic processing or isolator technology experience is desirable.
Ability to work in a dynamic, fast-paced, and goal-driven environment.
Strong decision-making capability.

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
Recognition & rewards program
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.

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