- Location
- Melbourne
- Workplace
- Onsite
- Type
- Full-time
- Department
- Asia Life Sciences
- Seniority
- Manager
- Visa
- Not sponsored
- Source
- Lever
Description
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:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
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 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.
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Skills
FDAComplianceProject Management
