At a Glance
- Tasks: Lead process development in a GMP-regulated environment for pharmaceutical projects.
- Company: Join a leading pharmaceutical company focused on innovation and compliance.
- Benefits: Attractive salary, career growth, and opportunities to work on impactful projects.
- Other info: Collaborative team environment with a focus on continuous improvement.
- Why this job: Make a difference in healthcare by optimising processes and ensuring quality.
- Qualifications: Experience in process engineering and strong knowledge of regulatory standards.
The predicted salary is between 90000 - 110000 $ per year.
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
- 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 Corporation
As a CQV Engineer II at our company, you will be part of a dynamic team dedicated to maintaining the integrity and professionalism of our products and services. We pride ourselves on fostering a collaborative work culture that encourages professional growth through mentorship and continuous learning opportunities. Located in a vibrant area, we offer competitive benefits and a supportive environment that values innovation and teamwork, making us an excellent employer for those seeking meaningful and rewarding careers in the life sciences industry.
