CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required. About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to over 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are You Ready? Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
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 domestically if required. Able to work in Australia without sponsorship. In return for your skills and knowledge, CAI offers a wide range of benefits including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting edge projects in a highly evolving field. #LI-JW1
