Project Manager

Role Overview

CAI is hiring a Project Manager in Australia to support commissioning, qualification, and validation work across life sciences and other regulated environments. The position focuses on driving C&Q delivery for clients in the pharmaceutical, medical device, and biotechnology sectors.

About CAI

CAI is an employee-owned organization founded in 1996 and has expanded to more than 850 employees around the world. The company delivers commissioning, qualification, validation, startup, project management, and consulting support to help operational readiness for FDA-regulated and other mission-critical industries.

CAI’s operating philosophy is built around putting the client first, persisting until the outcome is correct, and doing what is needed to achieve it. As employee-owners, the team follows foundational principles centered on integrity, helping one another, serving society, and planning for the future. The company emphasizes teamwork, mutual respect, and a proactive, can-do mindset.

Employees are exposed to advanced technologies in the medicine and life sciences space and may work alongside recognized subject matter experts. CAI also invests in training and certifications to support professional growth.

What the Role Involves

• Provide cGMP direction and support for integrating and delivering CQV services for life sciences clients.
• Lead mid-sized to large assignments involving process equipment, clean utilities, startup, and commissioning.
• Oversee design reviews, as well as site acceptance and installation activities for equipment.
• Prepare, review, and approve CQV documentation aligned with 21 CFR expectations, including SOPs, impact assessments, risk assessments, URS/FRS/DDS specifications, FATs, SATs, IOQ/PQs, validation protocols, and commissioning test plans.
• Support work performed both on site and remotely, including FATs, SATs, execution activities, and system walkdowns.
• Manage C&Q related activities such as change controls, contractor and vendor coordination, document control, and punch list tracking.
• Assign project resources to keep deliverables moving efficiently.
• Ensure C&Q tasks are completed according to schedule.
• Monitor progress and maintain dashboard updates.
• Coordinate support needed during C&Q execution.

What You Need

• A bachelor’s or master’s degree in a relevant science or engineering discipline, or equivalent practical experience.
• At least 5 years of experience in commissioning, qualification, validation, and compliance within life sciences or other regulated industries.
• Strong understanding of TGA expectations and global regulatory requirements.
• Solid working knowledge of cGMP standards.
• Experience delivering CQV outputs for one or multiple projects.
• Automation project management experience is strongly preferred.
• Strong ability to plan and monitor project tasks and timelines.
• Excellent relationship-building skills with both internal teams and external clients.
• Strong verbal and written communication abilities.
• Good problem-solving capability and a customer-focused mindset.
• High attention to detail.
• Hands-on knowledge of life science manufacturing processes such as biotech, aseptic processing, aseptic fill/finish, OSD, gene therapy, or similar.
• Excellent written and spoken English.
• Willingness to travel domestically or internationally when needed.
• Must be authorized to work in Australia without sponsorship.

Benefits

• Highly competitive compensation.
• Access to continuing education through internal and external learning opportunities.
• The chance to contribute to advanced, high-impact projects in a rapidly changing industry.

Additional Information

This position is not limited to the duties listed above, and additional responsibilities may be assigned when needed. CAI also considers qualified applicants with criminal histories in line with the Fair Chance Act and Fair Chance Ordinance requirements.

CAI may use artificial intelligence tools to assist with parts of hiring, such as application review, resume analysis, and identifying potential inconsistencies or verification signals. These tools support recruiters but do not replace human decision-making. Final hiring decisions are made by people. Applicants seeking details about data processing may contact the company directly.

The role is based in Melbourne, Victoria, Australia.