Manufacturing Engineer (GMP) Brisbane

POSITION SUMMARY:

The Manufacturing Engineer is responsible for supporting and ensuring systems, facilities, and
equipment meets the design requirements to be put in place for a facility. The
incumbent is also responsible and accountable for the execution of the PSC
mission, “to maintain the integrity and professionalism of our products and
services while enabling steady growth and development.”

DUTIES AND RESPONSIBILITIES:

• Collaborated
  with client teams to deliver CQV project objectives, managing timelines,
  dashboards, and status reporting to PSC Project Managers.
  
• Executed
  commissioning, qualification, and validation (CQV) activities, including
  FAT/SAT, IQ/OQ/PQ, risk assessments, and design reviews for facilities,
  utilities, and equipment.
  
• Authored
  and reviewed controlled GMP documentation, including SOPs, GDP records,
  validation protocols, reports, and technical specifications.
  
• Supported
  equipment and system implementation, driving process improvements and ensuring
  compliance with cGMP requirements.
  
• Facilitated
  cross -functional project delivery, coordinating stakeholders, vendors, and
  contractors to achieve project milestones.
  
• Led
  operator training and operational readiness activities, ensuring personnel
  competency and alignment with quality systems.
  
• Supported
  CQV and operation of single -use bioreactor (SUB) systems, including setup,
  troubleshooting, and compliant performance.
  
• Provided
  mentoring and technical guidance to client teams and junior staff across
  project activities.
  
• Contributed
  to continuous improvement initiatives to enhance quality, compliance, and
  operational efficiency across projects.
  

Requirements

• Bachelor’s Degree in Engineering or Life Science.
  
• 3 -5 years of applicable work experience in the
  biomedical and pharmaceuticals industry.
  
• Min 2 years of expertise in CQV
  
• 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 of developing, executing and maintaining
  CQV procedures and policies.
  
• Has good understanding and complies to cGMPs and Data
  Integrity guidelines.
  
• Knowledge of Bioprocess Manufacturing Operation in GMP Facility
  
• Experience with Smartsheet's, SOP, Track wise, or
  similar systems
  
• Familiarity with Delta V control and CAD software
  preferred.
  
• Excellent presentation and communication skills,
  written and oral, for a variety of audiences.
  
• Highly organized in planning and time management, with
  the ability to multi -task.