C&Q Engineer

biotech; City of Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

biotech seeks a C&Q Engineer to ensure GMP systems, facilities, and equipment meet design requirements for a new Melbourne facility.

You will plan, coordinate and execute commissioning, qualification and validation activities (DQ, FAT, SAT, IQ, OQ, PQ, PV), develop protocols and final reports, and support project teams across Engineering, Quality, Manufacturing and Project Management. You will mentor colleagues and ensure cGMP compliance and timely delivery.

Qualifications

• 5+ years of experience in pharmaceutical/biotech/GMP environments.
• Experience applying a risk-based CQV approach.
• Proficient in authoring and executing DQ, FAT, IQ, OQ, PQ, and PV documents.
• Proficient in developing SOPs, final reports and validation & quality policies.
• Experience with CQV procedures and policies.

Responsibilities

• Plan, coordinate, and execute commissioning, qualification and validation activities for GMP systems and equipment.
• Develop and review qualification protocols, test documentation, and validation reports.
• Write and revise GMP and GDP documents and technical specifications.
• Support FAT, SAT, commissioning and qualification activities throughout the project lifecycle.
• Develop SOPs and review final reports; mentor and consult to client and local team.

Skills

CQV knowledge

GMP experience

Project coordination

Documentation skills

Education

Bachelor's degree in Engineering/Science

Tools

Kaye Validator

Testo

Kneat

Job description

POSITION SUMMARY: The C&Q Engineer is responsible for ensuring systems, facilities, and equipment meet design requirements to be put in place for a facility.

Key Responsibilities Plan, coordinate, and execute commissioning, qualification, and validation activities for GMP systems and equipment. Develop and review qualification protocols, test documentation, and validation reports. Writes and revise GMP and GDP documents and technical specifications. Support FAT, SAT, commissioning, and qualification activities throughout the project lifecycle. Support development of SOPs and review final reports. Collaborate with Engineering, Quality, Manufacturing, and Project teams to ensure successful project delivery. Mentoring and providing consultation to the client and local team. Ensure compliance with cGMP requirements, regulatory standards, and company quality systems. Responsible for managing project activities and timelines. Provided status reports of projects to the PSC Project Manager.

Requirements Requirements: Bachelor Degree in Engineering, Science, or a related discipline. 5+ years’ experience within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments. Experience applying a risk-based CQV (Commissioning, Qualification & Validation) approach. Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents. Proficient in developing SOPS, final reports and validation & quality policies. Understanding, developing, executing and maintaining CQV procedures and policies. Experience performing temperature mapping of Controlled Temperature Chambers (CTCs) using systems such as Kaye Validator and/or Testo. Experience performing temperature mapping and qualification of benchtop autoclaves. Experience with digital validation platforms, preferably Kneat.