Manufacturing Engineer (GMP)

TL;DR

Manufacturing Engineer (GMP): Supporting and ensuring systems, facilities, and equipment meet design requirements for a GMP facility with an accent on commissioning, qualification, and validation (CQV) activities. Focus on executing FAT/SAT, IQ/OQ/PQ protocols, authoring controlled GMP documentation, and ensuring compliance with cGMP and data integrity guidelines.

Location: Brisbane, Australia (Onsite)

Company

hirify.global is a professional services firm providing consulting and project management solutions for the life sciences and pharmaceutical industries.

What you will do

• Execute commissioning, qualification, and validation (CQV) activities including FAT/SAT and IQ/OQ/PQ.
• Author and review controlled GMP documentation such as SOPs, validation protocols, and technical reports.
• Support equipment and system implementation while driving process improvements.
• Coordinate cross-functional project delivery with stakeholders, vendors, and contractors.
• Facilitate operator training and operational readiness to ensure personnel competency.
• Provide technical guidance and mentoring to client teams and junior staff.

Requirements

• Bachelor’s Degree in Engineering or Life Science.
• 3-5 years of work experience in the biomedical or pharmaceutical industry.
• Minimum 2 years of expertise in CQV.
• Proficiency in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Strong understanding of cGMP requirements and Data Integrity guidelines.
• Knowledge of Bioprocess Manufacturing Operations in a GMP facility.

Nice to have

• Familiarity with Delta V control systems.
• Experience with CAD software.
• Proficiency in Smartsheet or TrackWise systems.

Culture & Benefits

• Opportunity to work on diverse projects within the pharmaceutical and biomedical sectors.
• Focus on professional growth and development within a consulting environment.
• Collaborative team culture with emphasis on quality and compliance standards.