Process Engineering Manager

2 weeks ago

Brisbane, Queensland, Australia beBeeProcessEngineering Full time $150,000 - $200,000

About the Role

We are seeking a skilled and experienced Process Engineering Manager to lead our development sites and manufacturing facilities. This is an exciting opportunity for a professional with expertise in process development, scale-up, and cGMP manufacturing of protein-based pharmaceuticals.

Responsibilities:

  • Develop and implement strategies to improve operational efficiency and productivity.
  • Lead hands-on problem-solving efforts and root cause investigations to resolve deviations related to equipment, process or product.
  • Coordinate technology transfer, facility fit and implementation of NPIs along with PPQ and commercial DSP processes working with internal development teams and external clients.
  • Provide direction to the development sites regarding the facility-fit of new processes and technical expertise for manufacturing scale processes across the network.
  • Support late-phase process validation programs including Process Characterization (PC), Risk Assessments and Control Strategy.
  • Identify improvements and share best-practices across the network.
  • Generate, review and approve GMP documentation including Standard Operating Procedures (SOPs), Technical Transfer documents, Master Batch Records, Process Flow Diagrams and Bill of Materials.
  • Implement new technology and equipment within the production facility.

Requirements:

  • Tertiary degree in Science or Engineering preferably in biology, biotechnology, biochemistry, chemistry.
  • Previous management experience is preferable.
  • More than 5 years in a biopharmaceutical GMP manufacturing environment or a Process Development lab / pilot plant.
  • Knowledge of process development, scale-up and cGMP manufacturing of protein-based pharmaceuticals.
  • Experience with scale up of purification unit operations including chromatography and micro/ultra/nano filtration.
  • Experienced in leading RCAs and participating and leading Continuous Improvement (PPI) and Kaizen projects.
  • Biopharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable.

Skills and Attributes:

  • Strong analytical and problem-solving skills.
  • Ability to work in a matrix management system and influence and negotiate without direct authority.
  • Effective planning, resource, and time management skills.
  • Strong interpersonal and communications skills written and oral, and a demonstrated decision-making ability.

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