Engineer Fill Finish - Melbourne

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 essential
role in supporting the technical transfer of processes and products into GMP
manufacturing at PSC Biotech. This position requires a strong understanding of
fill & finish processes and the ability to collaborate effectively with
project teams. The ideal candidate will be responsible for assisting in the
creation of key documentation, ensuring project milestones are tracked, and
providing 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 process
  
• Oversee
  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 required
  
• Collect and trend process data for external (client) and internal
  review
  
• Support MES recipe startup, debugging, and documentation updates to align with process
  optimization efforts.
  
• Assist with training GMP Manufacturing staff on Client processes
  
• Provide
  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 SME
  
• Support MFG team with hands on cleanroom guidance as necessary
  
• Other duties as assigned
  

DEMONSTRATED COMPETENCIES:

• Business
  Development - Identify and
  target potential clients. Work in a team environment; develop and execute a
  plan, in alignment with company vision, mission and strategic plans to engage
  potential customers.
  
• Relationship Building –
  Works with and across formal and informal professional and social networks to
  build long-term partnerships and connections in the life science industry and
  Internal team.
  
• Negotiation Skills –
  Active listening, needs assessment, and presents visions to build a consensus.
  
• Analytical Skills –
  Identifies, researches, and demonstrates logical reasoning to communicate
  critical information.
  
• Rational Persuasion –
  Presents key factors, influencing factors, and strategic goals to assist
  stakeholders in identifying solutions.
  
• Interpersonal Awareness – Ability to be aware of how actions, ideas, and communication
  can/does affect people and their outcomes.
  
• Agility – Meets objectives by responding
  to competing and changing priorities and multiple tasks under inflexible
  timelines.
  

Requirements

REQUIRED 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 environment
  
• Expertise in sterile filtration, washer
  and tunnel validation, filling and capping operations, and isolator
  qualification.Experience with automation and process
  integration, including MES recipe development and debugging. desirable
  
• Experience in a
  CMO environment or in a similar client-customer based work environment is
  a plus
  
• On-site presence,
  as the role requires time on the manufacturing floor and cross-functional
  collaboration