Process Engineer

i-Pharm Consulting; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive remuneration package

Employee benefits

Job summary

i‑Pharm Consulting seeks a Bioprocess Engineer in Sydney to develop, optimize, scale and support manufacturing processes for recombinant protein production. You will work across upstream and downstream operations, process characterization, tech transfer and manufacturing support.

Join a collaborative team advancing cutting-edge biologics, with opportunities to drive process improvements, ensure GMP compliance, and contribute to tech transfer from lab to GMP facilities.

Qualifications

• Bachelor's degree in a biotech/bioprocess/chemical engineering field.
• Experience in biopharmaceuticals, biotechnology or GMP manufacturing environments.
• Hands-on mammalian cell culture and/or recombinant protein production.
• Understanding of upstream and downstream bioprocessing principles.

Responsibilities

• Support development and optimisation of mammalian cell culture processes from lab to pilot and manufacturing scale.
• Execute and analyse upstream process development studies including media optimisation, process characterisation and scale-up activities.
• Support downstream purification process development and process improvements.
• Assist with technology transfer of processes into GMP manufacturing environments.
• Prepare technical reports, protocols, batch records and manufacturing documentation.
• Investigate process deviations, implement corrective actions and support continuous improvement initiatives.
• Analyse process performance data and identify opportunities for increased efficiency and robustness.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing and Regulatory Affairs.
• Ensure compliance with GMP, safety and quality requirements.

Skills

Mammalian cell culture

Bioprocess engineering

Process scale-up

Technology transfer

GMP manufacturing

Data analysis

Problem-solving

Communication skills

Team collaboration

Process monitoring

Chromatography

Regulatory awareness

Education

Bachelor's degree in Biotechnology / Bioprocess Engineering / Chemical Engineering

Job description

Reporting to the Head of Process Development and Manufacturing, the Bioprocess Engineer will play a key role in developing, optimising, scaling and supporting manufacturing processes for recombinant protein production. The candidate will work across upstream and downstream operations, process characterisation, technology transfer and manufacturing support activities.

Key Responsibilities

• Support development and optimisation of mammalian cell culture processes from laboratory to pilot and manufacturing scale.
• Execute and analyse upstream process development studies including media optimisation, process characterisation and scale-up activities.
• Support downstream purification process development and process improvements.
• Assist with technology transfer of processes into GMP manufacturing environments.
• Prepare technical reports, protocols, batch records and manufacturing documentation.
• Investigate process deviations, implement corrective actions and support continuous improvement initiatives.
• Analyse process performance data and identify opportunities for increased efficiency, productivity and robustness.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing and Regulatory Affairs.
• Ensure compliance with GMP, safety and quality requirements.

Skills & Experience

• Bachelor's degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, Biochemistry or a related discipline.
• Experience in biopharmaceutical, biotechnology or GMP manufacturing environments.
• Hands-on experience with mammalian cell culture and/or recombinant protein production.
• Understanding of upstream and downstream bioprocessing principles.
• Experience with process scale-up, technology transfer or manufacturing support activities will be highly regarded.
• Strong data analysis, problem-solving and troubleshooting skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a collaborative, multidisciplinary team environment.
• Exposure to GMP manufacturing operations.
• Experience with bioreactor operations and process monitoring systems.
• Knowledge of chromatography and protein purification techniques.
• Familiarity with process validation and regulatory requirements for biologics.
• Experience within a clinical or commercial biopharmaceutical manufacturing setting.
• Join an innovative Australian biotechnology company with world-class technology.
• Work directly on cutting-edge biologics and therapeutic development programs.
• Opportunity to make a meaningful impact in a growing organisation.
• Collaborative, science-driven culture with strong career development opportunities.
• Competitive remuneration package and employee benefits.