Project Manager (CQV) - Melbourne

Location: Melbourne, Australia

Company

hirify.global provides project and technical services for life science projects, including commissioning, qualification, and validation support.

What you will do

• Coordinate assigned projects, internal teams, external vendors, schedules, budgets, timelines, and deliverables.
• Execute project implementation in alignment with management direction while ensuring regulatory, quality, and validation requirements are met.
• Collaborate with client teams on commissioning and qualification activities for facilities, utilities, equipment, and filling lines.
• Lead risk analyses, design reviews, and execution of FAT, SAT, IQ, OQ, and PQ activities.
• Author, revise, and review controlled documents, GMP/GDP documentation, technical specifications, SOPs, and final reports.
• Provide mentorship and consultation to clients and internal cross-functional teams.

Requirements

• Bachelor’s Degree in Engineering, preferably Chemical or Mechanical, or a related Life Science degree.
• 7–10 years of related experience in the life science sector and 4+ years of project management experience in GMP-regulated environments.
• Minimum 3 years of expertise in CQV or Fill Finish within GMP-regulated environments.
• Proficiency in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Proficiency in developing SOPs, final reports, and validation and quality policies.
• Understanding of developing, executing, and maintaining CQV procedures and policies, with compliance with cGMPs and Data Integrity guidelines.
• Understanding of cost and risk management and various project management methodologies.
• Ability to evaluate challenges, identify solutions, and utilize resources effectively.
• Exceptional interpersonal, communication, planning, project management, and organizational skills, including the ability to lead multiple activities and resources while maintaining a focus on quality.

Nice to have

• MBA or project management certification.

Culture & Benefits

• Work involves collaboration with clients, internal teams, external vendors, and stakeholders across the life science industry.
• The role requires relationship building, negotiation, analytical reasoning, interpersonal awareness, agility, and the ability to manage competing priorities.
• Projects are delivered under quality, regulatory, schedule, budget, and changing-priority constraints.