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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 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

Blue Projects is one of the most dynamic firms, specializing in providing unique and bespoke Engineering and Project Management solutions for clients in the industrial sector.

To further our strategic business growth, we are looking for a passionate Process Engineer in our office in NSW or Victoria.

Requirements:

- Minimum 7 years of experience in Process Engineering/Project Management in industrial sectors, preferably FMCG or similar.
- Bachelor's or Honours Degree in Chemical/Process Engineering, Industrial Chemistry, or a related field.
- Strong skills in generating PFDs, P&IDs;, and performing process calculations such as mass and energy balances.
- Proficiency in plant layout design, piping/mechanical design, and detailing.
- Experience with multidisciplinary coordination, including civil, mechanical, electrical, automation, and production teams.
- Ability to work effectively in a team.
- Advanced time management, analytical, and interpersonal skills.
- Proficient in 2D and 3D CAD systems.
- Working knowledge of Microsoft Office; knowledge of Microsoft Project is an advantage.
- Willingness to travel for business trips and project‑related relocations.

Responsibilities:

- Review project deliverables to define process requirements.
- Develop PFDs, P&IDs;, and equipment layouts for industrial projects.
- Collaborate with clients and stakeholders to confirm project design requirements.
- Design and manage manufacturing processes to optimize safety, performance, and compliance with quality standards.
- Perform process simulations and troubleshoot issues as needed.
- Create detailed piping, insulation, instrumentation, and equipment specifications.
- Produce tender or RFQ documents as required for project execution.
- Create, verify, and validate Material Take Off (MTOs).
- Liaise with equipment, instrument, and installation suppliers on specifications, design, and delivery.
- Prepare and complete project plans, ensuring all milestones are met.
- Propose design improvements, implement changes, and ensure quality assurance.
- Monitor and report project progress to stakeholders.
- Conduct risk assessments, FMEAs, HAZOPs, Hazardous Area classifications, and LOPA studies.




- Develop Functional Design Specifications (FDS) and Standard Operating Procedures (SOP).
- Participate in on‑site commissioning of plant and equipment, including mechanical completion verification, punch listing, cold & hot commissioning, performance acceptance testing (PAT), and final handover.

TOP reasons why Blue Projects may be a strategic choice:

- International exposure, working with global brands in the FMCG industry
- Annual financial rewards and salary raises according to a solid and replicable performance appraisal program
- Real career opportunities and advancement perspectives within our supportive teams
- Smart, kind, and open to communication team environment
- Access to online learning platforms
- Psychological and well‑being services offered by a well‑known provider

We are looking for a Process Engineer - Utilities to join our team on a 12‑month contract. Work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape.

The role is also responsible and accountable for supporting the PSC mission: “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

Key Duties and Responsibilities

- Support process engineering activities for new, modified, and existing utility and manufacturing systems across the project lifecycle.
- Support the design, installation, startup, commissioning, qualification, and optimisation of utility systems and associated process equipment.
- Prepare, review, revise, and complete controlled engineering and CQV documentation, including specifications, drawings, risk assessments, test protocols, reports, procedures, and turnover records.
- Execute and document DQ, FAT, SAT, IQ, OQ, PQ, and other commissioning or validation activities, as applicable to the assigned systems and project scope.
- Perform field verification, system walkdowns, inspections, testing, troubleshooting, and readiness checks for utilities, equipment, instruments, controls, and interfaces.
- Assess utility capacity, performance, reliability, and compliance against process requirements, user requirements, design intent, and operational needs.
- Support process startup and the introduction of new or modified equipment and systems into GMP operations.
- Provide process engineering input into technical specifications, equipment selection, P&IDs;, layouts, control strategies, operating parameters, and system boundaries.
- Assist with technology transfer, process scale‑up, equipment readiness, and the development or revision of SOPs and operating documentation.
- Troubleshoot process and utility issues, identify root causes, and recommend practical improvements that strengthen safety, compliance, reliability, and performance.
- Collaborate with client teams, quality, operations, maintenance, automation, vendors, and contractors to deliver project milestones and resolve technical issues.
- Provide clear progress updates, escalate risks or constraints promptly, and complete assigned deliverables within agreed timelines.
- Work safely and comply with PSC and client policies, procedures, permit requirements, and site safety expectations.
- Additional duties and responsibilities may be assigned from time to time.

Utilities Experience

- Experience supporting one or more of the following is desirable, depending on the project scope:
- Clean and process utilities, such as purified water, water for injection, clean steam, process gases, compressed air, and clean‑in‑place systems.
- Plant utilities, such as HVAC, chilled water, cooling water, glycol, steam, condensate, electrical interfaces, and waste systems.
- Process equipment, including vessels, pumps, valves, heat exchangers, piping, instrumentation, automated skids, and associated control systems.
- Aseptic, controlled, or highly automated manufacturing environments.

Requirements

- Bachelor Degree in Engineering, Science, or a related discipline.
- At least 2 years of relevant engineering experience within pharmaceutical, biotechnology, medical device, or another regulated GMP environment.
- Practical experience supporting process development, utilities, equipment startup, commissioning, qualification, validation, or manufacturing operations.
- Experience preparing, reviewing, or executing engineering and CQV documentation, such as specifications, risk assessments, FAT, SAT, IQ, OQ, PQ, protocols, and reports.
- Working knowledge of GMP, GDP,



data integrity, quality systems, and regulated project delivery expectations.
- Ability to read and interpret technical drawings, P&IDs;, specifications, manuals, and vendor documentation.
- Strong analytical, troubleshooting, organisation, and written communication skills.
- Ability to work collaboratively across disciplines and manage competing priorities in a project workplace.

In Melbourne, water is essential to our way of life.

As caretakers for Melbourne’s water cycle, and our catchments. We care for water, life, and land throughout Melbourne: both its people and its biodiversity.

Each time you drink from the tap, flush a toilet, or kayak down the Yarra we’re there. Primed and ready, quietly delivering some of the world’s cleanest water for over five million residents and wildlife that call Melbourne home, just as we have for over 130 years.

About the Role

As Senior Process Engineer, Sewerage Planning, you will help shape the long‑term future of Melbourne’s sewerage services. You will develop adaptive strategies and plans that respond to emerging challenges and opportunities, including population growth, climate change, community and environmental impacts, and resource recovery.

Drawing on your technical expertise, you will identify and evaluate future infrastructure and operational requirements, contribute to concept designs, trials and business cases, and provide clear, evidence‑based advice to senior leaders and stakeholders. You will also build strong internal and external relationships, manage specialist consultants and help translate complex technical information into practical, forward‑looking solutions.

- Develop strategies and plans with a 5‑50+ year view related to the sewerage service, and work across the organisation to manage the implementation of relevant plans. These plans should be adaptable to a range of potential future scenarios.
- Identify and quantify current and potential future sewerage systems opportunities and risks, including (but not limited to) community and environmental impacts, climate change, population growth and resource recovery.
- Identify, investigate, evaluate (including supporting development of concept designs and trials/pilots where required), and support development of business cases for potential future capital assets, operational activities, planning controls, and other initiatives that could contribute to managing the sewerage service.
- Provide clear, evidence‑based advice to internal and external stakeholders, including senior executive and board level stakeholders, in relation to the sewerage service.
- Maintain a sound understanding of trends in local and international sewerage system, sewage treatment practices regulation and policy to inform medium – long term plans.

For more Information, please refer to the Role Mandate

About you:

- Expertise and technical leadership skills in developing and implementing strategies and plans (including adaptive planning) and influencing policies.
- Expertise and technical leadership skills in sewerage services.
- Demonstrated capability to confidently, professionally, and persuasively communicate detailed technical information to a range of audiences including senior executive and board level stakeholders, in both written and oral formats.
- Demonstrated capability to support and make decisions in ambiguous, complex, and uncertain contexts.
- Understanding of strategy development and long‑term planning
- Understanding of trends in local and international sewerage system, sewage treatment practices regulation and policy to inform medium – long term plans.
- Relevant Tertiary qualification in Engineering
- Current Victorian driver’s licence

Why join us:

At Melbourne Water, we care deeply about water and the life it sustains.

Our team is inspired by passion and purpose, with an unwavering commitment to safety. We are on a mission to protect every Melburnian’s way of life, one drop at a time.

We don’t just talk about versatile working - we live it. Our culture of purpose, safety, results, and learning flows through everything we do. We're dedicated to doing what's right, and this commitment extends to the meaningful work we do in a supportive and inclusive culture that encourages you to make the most of your talents.

Our long‑standing commitment to Diversity, Inclusion, and Belonging means that Aboriginal and Torres Strait Islander peoples, LGBTIQ+ individuals, Neurodivergent Individuals, people living with disability, mature age and young jobseekers from all cultures can apply with confidence knowing they are safe, affirmed, and celebrated.

If you’re curious, action‑orientated, outcomes‑focused, and enthusiastic about public resources, community, and the environment, we'd love to receive your application and learn if you could be a great fit.

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📌 Process Engineer (Melbourne)
🏢 Asahi
📍 Melbourne