Engineer Fill Finish - Melbourne

POSITION SUMMARY:

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 handson 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 JAG 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 longterm 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 JAG recipe development and debugging. desirable
  
• Experience in a CMO environment or in a similar clientcustomer based work environment is a plus
  
• Onsite presence as the role requires time on the manufacturing floor and crossfunctional collaboration
  

This position is subject to a background check with satisfactory results. This is required post offer and before the first day.