Lead Process Engineer

CSL Seqirus

Liverpool, Australia
7+ years biotech/pharma experience
Cgmp regulatory compliance knowledge
Process design and equipment specification
This position provides technical leadership for equipment and process design ensuring solutions meet cost, reliability, schedule, and performance integrity requirements

Job Summary

  • This position provides technical leadership for equipment and process design ensuring solutions meet cost, reliability, schedule, and performance integrity requirements.
  • The role involves leading process safety initiatives, conducting HAZOP studies, and managing the full lifecycle from preliminary design to routine manufacturing in a cGMP environment.
  • CSL Seqirus offers a culture focused on inclusion, belonging, and anticipating potential problems while maintaining high standards of GMP and safety across global operations.

Matching Summary

This position provides technical leadership for equipment and process design ensuring solutions meet cost, reliability, schedule, and performance integrity requirements.

Skills & Requirements

Must-have

  • 7+ years Biotech/Pharma experience
  • cGMP regulatory compliance knowledge
  • Process design and equipment specification
  • HAZOP studies and process safety leadership
  • Commissioning validation (FAT SAT IQ OQ PQ)
  • Change control management expertise
  • Budget development Capex Opex funding

Nice-to-have

  • Chartered Engineer status preferred
  • Culture of participation and innovation
  • External focus on industry best practices
  • Cross-functional team collaboration skills
  • Knowledge sharing and mentoring abilities

Key Requirements

  • Recognized degree in Chemical or Process Engineering
  • 7+ years experience in Biotech or Pharma manufacturing
  • Fully conversant with application routes for Chartered Engineer status
  • Specific background in cGMP regulations required

Work Rights

Not specified

Tailored Resume

Cover Letter