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 strong 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
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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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In office 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