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.
Solid experience developing and executing CQV protocols.
Strong experience creating and maintaining CQV policies and processes.
Has good understanding and complies
to
cGMPs
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

📌 Senior Process Engineer Melbourne
🏢 PSC Biotech
📍 Melbourne