Job Description

POSITION SUMMARY :

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We are looking for a Fill Finish Engineer to join our team on a 12-month contract . The Fill Finish Engineer will play an essential
n role in supporting the technical transfer of processes and products into GMP
n manufacturing at PSC Biotech. This position requires a robust understanding of
n fill & finish processes and the ability to collaborate effectively with
n project teams. The ideal candidate will be responsible for assisting in the
n creation of key documentation, ensuring project milestones are tracked, and
n providing hands-on support in cleanroom environments.

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DUTIES AND RESPONSIBILITIES:

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- Partner with GMP manufacturing and Capital project teams as the Fill
n Finish SME in a greenfield fill & finish process

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- Oversee
n automation readiness, ensuring system integration with filling lines and
n compliance with validation requirements.

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- Document
n protocols, engineering tests, and validation reports to ensure compliance
n with regulatory and client requirements.

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- Working closely with the Fill Finish team ensure project milestones
n are achieved and attending reoccurring and adhoc meetings as required

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- Collect and trend process data for external (client) and internal
n review

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- Support MES recipe startup, debugging, and documentation updates to align with process
n optimization efforts.

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- Assist with training GMP Manufacturing staff on Client processes

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- Provide
n deviation resolution and qualification support by addressing process
n deviations, troubleshooting startup and PQ issues, and coordinating with the
n client and vendors to maintain project timelines.Assist Clients in regulatory filing support as a process SME

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- Support MFG team with hands on cleanroom guidance as necessary

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- Other duties as assigned

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DEMONSTRATED COMPETENCIES:

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- Business




n Development - Identify and
n target potential clients. Work in a team environment; develop and execute a
n plan, in alignment with company vision, mission and strategic plans to engage
n potential customers.

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- Relationship Building –
n Works with and across formal and informal professional and social networks to
n build long-term partnerships and connections in the life science industry and
n Internal team.

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- Negotiation Skills –
n Active listening, needs assessment, and presents visions to build a consensus.

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- Analytical Skills –
n Identifies, researches, and demonstrates logical reasoning to communicate
n critical information.

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- Rational Persuasion –
n Presents key factors, influencing factors, and strategic goals to assist
n stakeholders in identifying solutions.

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- Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication
n can/does affect people and their outcomes.

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- Agility – Meets objectives by responding
n to competing and changing priorities and multiple tasks under inflexible
n timelines.

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Requirements n

REQUIRED EDUCATION AND WORK EXPERIENCE:

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- B.S. in Chemical Engineering, Chemistry,
n Biology, Life Sciences, or related field with 3+ years of experience in
n fill & finish validation and process engineering -OR- equivalent
n industry experience.Knowledge/expertise relevant to protein and virus
n manufacturing in a cGMP environment

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- Expertise in sterile filtration, washer
n and tunnel validation, filling and capping operations, and isolator
n with automation and process
n integration, including MES recipe development and debugging. desirable

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- Experience in a
n CMO environment or in a similar client-customer based work environment is
n a plus

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- On-site presence,
n as the role requires time on the manufacturing floor and cross-functional
n collaboration

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📌 Engineer Fill Finish - Melbourne
🏢 PSC Biotech
📍 Melbourne