POSITION SUMMARY: We are looking for a Fill Finish Engineer to join our team on a 12-month contract.
The Fill Finish Engineer will play an essentialrole in supporting the technical transfer of processes and products into GMPmanufacturing at PSC Biotech.
This position requires a strong understanding offill & finish processes and the ability to collaborate effectively withproject teams.
The ideal candidate will be responsible for assisting in thecreation of key documentation, ensuring project milestones are tracked, andproviding hands-on support in cleanroom environments.
DUTIES AND RESPONSIBILITIES:Partner with GMP manufacturing and Capital project teams as the Fill Finish SME in a greenfield fill & finish processOversee automation readiness, ensuring system integration with filling lines and compliance with validation requirements.Document protocols, engineering tests, and validation reports to ensure compliance with regulatory and client requirements.Working closely with the Fill Finish team ensure project milestones are achieved and attending reoccurring and adhoc meetings as requiredCollect and trend process data for external (client) and internal reviewSupport MES recipe startup, debugging, and documentation updates to align with process optimization efforts.Assist with training GMP Manufacturing staff on Client processesProvide deviation resolution and qualification support by addressing process deviations, troubleshooting startup and PQ issues,



and coordinating with the client and vendors to maintain project timelines.Assist Clients in regulatory filing support as a process SMESupport MFG team with hands on cleanroom guidance as necessaryOther duties as assignedDEMONSTRATED COMPETENCIES:BusinessDevelopment - Identify andtarget potential clients.
Work in a team environment; develop and execute aplan, in alignment with company vision, mission and strategic plans to engagepotential customers.Relationship Building –Works with and across formal and informal professional and social networks tobuild long-term partnerships and connections in the life science industry andInternal team.Negotiation Skills –Active listening, needs assessment, and presents visions to build a consensus.Analytical Skills –Identifies, researches, and demonstrates logical reasoning to communicatecritical information.Rational Persuasion –Presents key factors, influencing factors, and strategic goals to assiststakeholders in identifying solutions.Interpersonal Awareness – Ability to be aware of how actions, ideas, and communicationcan/does affect people and their outcomes.Agility – Meets objectives by respondingto competing and changing priorities and multiple tasks under inflexibletimelines.RequirementsREQUIRED EDUCATION AND WORK EXPERIENCE:B.S. in Chemical Engineering, Chemistry, Biology, Life Sciences, or related field with 3+ years of experience in fill & finish validation and process engineering -OR- equivalent industry experience.Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environmentExpertise in sterile filtration, washer and tunnel validation, filling and capping operations, and isolator with automation and process integration, including MES recipe development and debugging.
desirableExperience in a CMO environment or in a similar client-customer based work workplace is a plusOn-site presence, as the role requires time on the manufacturing floor and cross-functional collaboration

📌 Engineer Fill Finish - Melbourne
🏢 PSC Biotech
📍 Melbourne