Project Manager
Project Manager
Posted on :
07-04-2025
Employer Active
1 Vacancy
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Job Description
CAI is looking for individuals with arangeof experiencein the areas of commissioning qualification and validation to join ourteam in Australia.Experience in the pharmaceutical medical deviceor biotechnologyindustries is required.
About CAI:
CAI is a 100 employeeowned company established in 1996 it has grown year over year to over 850 people worldwide. We provide commissioning qualification validation startup 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 clients 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 persons success is everyones success; we work diligently to accomplish team goals. We place Team Before Self demonstrate Respect for Others and possess a cando 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 midsized to large projects related to process equipment and clean utilities including startup 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 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
Position Requirements:
BS or MS in a relevant science or engineering field or equivalent years of handson 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 problemsolving skills
Customerservice 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.
#LIJW1
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company.We pledge that CAI will be operated in a way that is fair and equitable to all our employees our customers and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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