Process Validation Scientist

Evolve Scientific; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

Evolve Scientific in Melbourne seeks a Process Validation Scientist/Senior Scientist/Process Engineer to join the technical operations team. The role is a 2-year fixed term contract with potential to go permanent.

You will work closely with Manufacturing, Quality, Engineering and Regulatory teams in a GMP-regulated environment, leading validation activities and coordinating transfer and scale-up efforts to ensure product quality and process robustness.

Qualifications

• Bachelor's degree in a relevant scientific field.
• Previous experience with process validation in pharma/biotech/biomanufacturing environments.
• Strong GMP knowledge and regulatory expectations.
• Experience writing validation protocols, reports, risk assessments and change controls.
• Exposure to process improvement, transfer, qualification or manufacturing support.

Responsibilities

• Lead process validation activities for new products and changes to manufacturing processes.
• Develop and execute validation protocols, reports, risk assessments and change controls.
• Support continued process verification and ongoing process monitoring programs.
• Coordinate process transfer, technical trials and scale-up activities.
• Support equipment qualification, cleaning validation and implementation of new technologies.
• Investigate deviations, perform root cause analyses and implement corrective actions.
• Prepare and maintain GMP docs including SOPs, validation protocols and plans.
• Drive continuous improvement to enhance process performance and product quality.

Skills

Process validation

Regulatory compliance

Documentation

Cross-functional collaboration

Problem-solving

Technical writing

Education

Bachelor's degree in Science/bioprocessing/biotechnology/chemical engineering

Job description

• A leading global pharmaceutical and biotechnology manufacturing organisation.
• Seeking a Process Validation Scientist / Senior Scientist / Process Engineer to join their Melbourne-based technical operations team.
• 2 years fixed term contract with potential to go permanent.
• Work closely with Manufacturing, Quality, Engineering and Regulatory teams in a highly regulated GMP environment.

About the company/role:

• A leading global pharmaceutical and biotechnology manufacturing organisation.
• Seeking a Process Validation Scientist / Senior Scientist / Process Engineer to join their Melbourne-based technical operations team.
• 2 years fixed term contract with potential to go permanent.
• Work closely with Manufacturing, Quality, Engineering and Regulatory teams in a highly regulated GMP environment.
• Melbourne location.

Duties:

Reporting to the Technical Manager, your duties may include:

• Leading process validation activities for new products and changes to existing manufacturing processes.
• Developing and executing validation protocols, reports, risk assessments and change controls.
• Supporting continued process verification and process monitoring programs.
• Coordinating process transfer, technical trial and scale-up activities.
• Supporting equipment qualification, cleaning validation and implementation of new technologies.
• Investigating process deviations, performing root cause analysis and implementing corrective actions.
• Preparing and maintaining GMP documentation including SOPs, validation protocols, reports and validation plans.
• Driving continuous improvement initiatives to enhance process performance and product quality.

About you:

• Bachelor's degree in Science, Biotechnology, Microbiology, Bioprocessing, Chemical Engineering or a related discipline.
• Previous experience in process validation within pharmaceutical, biotechnology or biomanufacturing environments.
• Strong understanding of GMP requirements, validation principles and regulatory expectations.
• Experience authoring technical documentation including validation protocols, reports, risk assessments and change controls.
• Exposure to process improvement, process transfer, equipment qualification or manufacturing support activities.
• Excellent communication, stakeholder management and technical writing skills.
• Strong problem-solving skills with the ability to work collaboratively across multiple departments.