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
Cloud • Information Technology • Productivity • Security • Software • App development • Automation
Build and lead Atlassian’s APAC implementation practice by hiring and developing delivery teams, leading pre-sales scoping, overseeing enterprise cloud implementations, and ensuring customer outcomes. Own portfolio quality, delivery governance, utilization, capacity, forecasting, margins, and operating discipline. Partner with Sales, Finance, Customer Success, Services Operations, and solution partners to scale implementation offerings across APAC. This player-coach role also involves hands-on customer engagements, technical discovery, and up to 30% regional travel.
Top Skills:
AIAtlassian CloudAutomationConfluenceJIRAJira Service Management
Blockchain • eCommerce • Fintech • Payments • Software • Financial Services • Cryptocurrency
Own the full outbound sales cycle for mid-market merchants, including prospecting, pipeline development, discovery, demos, negotiation, and closing. Build tailored multi-product solutions, acquire net-new business, manage complex multi-stakeholder deals, forecast accurately in Salesforce, and consistently exceed revenue targets. Collaborate with business development, product, marketing, implementation, and operations teams while serving as a trusted consultative advisor.
Top Skills:
Salesforce
Artificial Intelligence • Consumer Web • Edtech • Enterprise Web • HR Tech • Social Impact • Generative AI
Executes APAC regional marketing programs supporting pipeline and revenue goals, including ABM campaigns, events, trade shows, webinars, PR, demand generation, and content localization. Partners with global marketing, sales, and customer success teams to adapt and repurpose content, manage campaigns, and meet deadlines across a distributed organization.
Top Skills:
Adobe Creative SuiteCanvaHubspotMailchimpMarketoSalesforce
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.
