Senior Process Engineer - GMP & CQV Specialist

PSC Biotech; Melbourne; Hybride; AUD 130 000 - 170 000; Plein temps

Résumé du poste

PSC Biotech in Melbourne, Australia is seeking a Senior Process Engineer to support process development within a GMP environment. You will define process requirements for pharmaceutical projects, support technology transfer, risk assessments, and compliance to ensure project execution and readiness.

You will lead technical evaluations, risk analyses, and CQV activities while collaborating with cross-functional teams to implement compliant process solutions across manufacturing environments.

Qualifications

• Proficient in planning and executing DQ, FAT, SAT, IQ, OQ, PQ and PV documents.
• Experience creating SOPs, final reports and validation policies.
• Strong CQV protocol experience and policy development.
• Good understanding of cGMPs and CFR21 Part 11 guidelines.
• Exposure to validation platforms like Kneat.
• Background in PFS tech, vial filling and sterile filtration.

Responsabilités

• Provide technical leadership across process technologies in capital projects and manufacturing support.
• Define process design requirements aligned with regulatory expectations.
• Support transfer packages, data reviews, and manufacturing requirements.
• Partner with project, operations, quality, and engineering teams.
• Lead risk assessments and process improvement initiatives.
• Support design, commissioning, qualification, and validation of process systems.
• Participate in design reviews, investigations and process optimisation.
• Ensure changes are documented and compliant within QM systems.
• Facilitate FMEA, hazard analyses, and risk mitigation.
• Ensure compliance with quality, validation, engineering, and regulatory standards.

Connaissances

DQ/DQ, FAT, SAT, IQ/OQ/PQ/PV docs

CQV protocols

SOPs & validation policies

cGMPs & 21 CFR Part 11

Kneat platform

Cross-functional collaboration

Outils

Kneat

Description du poste

Melbourne, Australia | Posted on 08/17/2026

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 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