Project Manager

CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose informs everything we do: • We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. At CAI, we are committed to living our Foundational Principles, both professionally and personally: • We act with integrity • We serve each other • We serve society • We work for our future At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. Requirements include: Position Description: We are now seeking a Project Manager to join our growing operations in Australia. The role of a Project Manager in CAI is to: - Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. - Managing mid-sized to large projects related to process equipment and clean utilities including start-up and commissioning - Lead design review, site acceptance and installation of equipment - Write, Review and Approve CQV documents following established 21 CFR standards, both internally and externally. Document requests could include: Standard Operating Procedures, Impact Assessments, Risk Assessments, Specifications (URS/FRS/DDS), FATs, SATs, IOQ/PQs, Validation Protocols and Commissioning Test Plans - Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns - Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management. - Allocate project resources for efficient execution of project deliverables. - Deliver the C&Q activities as required to meet the schedule - Track progress of C&Q activities as required and update dashboards - Coordinate support during C&Q execution Position Requirements: BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience 5 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of TGA and global regulatory requirements. Proficient in cGMP standards. Experience in collaborating and managing Commissioning, Qualification and Validation deliverables for one or Multiple Projects Automation PM experience highly desired Skilled at planning and tracking project activities and schedules Excellent interpersonal skills to form strong relationships with internal and external clients. Excellent oral and written communication skills Excellent problem-solving skills Customer-service focused. High attention to detail. Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. Other Requirements: Excellent oral and written English are required. Able to travel internationally or…