Provides technical leadership for pharmaceutical process development and manufacturing projects in a GMP-regulated environment. Defines process requirements, supports equipment and system design, technology transfer, commissioning, qualification, validation, risk assessments, troubleshooting, investigations, and continuous improvement. Partners with project, operations, quality, and engineering teams to ensure compliant process integration and operational readiness. Authors and executes validation documentation, develops SOPs and CQV protocols, and supports manufacturing technologies including pre-filled syringes, vial filling, sterile filtration, bulk product, NPI, and plasma manufacturing.
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
Similar Jobs
Aerospace • Artificial Intelligence • Machine Learning • Robotics • Software
Leads and scales Shield AI’s international Aechelon sales organization, integrating the acquired business into Shield AI’s go-to-market strategy. Responsibilities include sales team leadership, post-acquisition integration, territory and account planning, pipeline and forecast management, complex defense and enterprise pursuits, cross-selling, partner development, and alignment with product, engineering, marketing, and customer engagement teams.
Top Skills:
AechelonAi/MlAutonomy SoftwareCRMHivemindSaaSSimulation TechnologySynthetic RealityVisualization Platforms
Cloud • Fintech • Information Technology • Machine Learning • Software
Drive revenue growth across small and medium-sized business accounts through high-volume outbound campaigns. Promote Stripe, GoCardless, and other financial integrations; manage account pipelines, track conversion metrics, maintain Salesforce records, and optimize messaging. The role requires consultative communication, consistent performance against activity targets, and collaboration with Marketing, Data Science, and Customer Success teams.
Top Skills:
GocardlessSalesforceStripe
Cloud • Fintech • Information Technology • Machine Learning • Software
Drive small-business revenue growth through high-volume outbound campaigns. Promote integrated payment and financial solutions, manage conversion pipelines, track sales activity and metrics, maintain Salesforce records, and optimize messaging based on customer insights. The role requires consultative communication, proactive prospecting, pipeline management, and collaboration with Marketing, Data Science, and Customer Success teams in a hybrid work environment.
Top Skills:
GocardlessSalesforceStripe
What you need to know about the Melbourne Tech Scene
Home to 650 biotech companies, 10 major research institutes and nine universities, Melbourne is among one of the top cities for biotech. In fact, some of the greatest medical advancements were conceptualized and developed here, including Symex Lab's "lab-on-a-chip" solution that monitors hormones to predict ovulation for conception, and Denteric's vaccine for periodontal gum disease. Yet, the thousands of people working in the city's healthtech sector are just getting started, to say nothing of the tech advancements across all other sectors.
