At a Glance
- Tasks: Lead process development in a GMP-regulated environment for pharmaceutical projects.
- Company: Join a leading pharmaceutical company in Melbourne with a focus on innovation.
- Benefits: Attractive salary, career growth opportunities, and a collaborative work culture.
- Other info: Dynamic team environment with opportunities for continuous improvement and technical leadership.
- Why this job: Make a real impact in the pharmaceutical industry while advancing your engineering skills.
- Qualifications: Experience in process engineering and compliance with cGMP standards required.
The predicted salary is between 90000 - 110000 $ per year.
Melbourne, Australia
We are seeking a Senior Process Engineer to support ongoing process development within a GMP ‑ regulated environment .
This role will play a key part in defining and managing process requirements for pharmaceutical projects, supporting system design, technology transfer, risk assessments, and compliance activities to ensure successful project execution and operational readiness.
Key Responsibilities
- Provide technical leadership in the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities.
- Develop and maintain process design requirements, ensuring they are clearly defined, measurable, and aligned with project objectives and regulatory expectations.
- Review and interpret process data, technology transfer packages, and manufacturing requirements to support equipment and system design decisions.
- Partner with project, operations, quality, and engineering teams to ensure process solutions are effectively integrated into manufacturing environments.
- Lead technical evaluations and risk-based assessments to identify process improvement opportunities and mitigate operational risks.
- Support the design, commissioning, qualification, and validation of new and modified process systems to ensure they meet performance and compliance requirements.
- Provide subject matter expertise during design reviews, troubleshooting activities, investigations, and process optimisation initiatives.
- Ensure process changes are appropriately assessed, documented, and implemented through established quality and change management systems.
- Facilitate risk assessments, FMEAs, and process hazard analyses to support project delivery.
- Ensure compliance with quality, validation, engineering, and regulatory standards.
- Partner with cross-functional teams to resolve technical issues and drive continuous improvement initiatives.
Requirements
Requirements
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPs, final reports and validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Has good understanding and complies to c GMPs and CFR21 Part 11 guidelines.
- Exposure to digital and paper-based validation systems, including platforms such as Kneat .
- Background in Pre-filled syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, New Product Initiative (NPI) manufacturing, Plasma Manufacturing
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Senior Process Engineer – Melbourne employer: PSC Biotech
As a Senior Process Engineer in Melbourne, you'll join a dynamic team dedicated to innovation in the pharmaceutical sector. Our company fosters a collaborative work culture that prioritises employee growth through continuous learning and development opportunities, while also offering competitive benefits and a commitment to compliance and quality. With a focus on operational excellence and cutting-edge technology, we provide a rewarding environment where your expertise will directly contribute to impactful projects.
