CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 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.
Meeting a Higher Standard
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.
We are now seeking a Process Manufacturing Technology (PMT) Senior Consultant to join our growing operations in Switzerland. The role of a Process Manufacturing Technology (PMT) Senior Consultant in CAI is to:
· Support technology transfers of early pipeline to commercial products, including lifecycle management. He/her provide solutions and implement actions during the product development process and establish the infrastructure needed for manufacturing.
Tech Transfer Experience:
· Five (5) or more years of experience in Technology Transfer
· Support technology transfers of early pipeline to commercial products, including lifecycle management.
· Conduct make-a-batch exercises to resolve facility fit and identify gaps
· Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
· Author and/or own technology transfer and other technical documents
· Work directly with clinical and commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization
· Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
· Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance technology transfer projects as well as improvement initiatives
· Deliver progress reports and presentations to engage with and ensure that management is aware of the current status and progress
· Knowledge of analytical methods and applicable tech transfer methodology
· Duties include optimizing manufacturing efficiency, reliability, and throughput.
· Provide support in the enterprise resource planning (ERP) development and training and formulating lean manufacturing methods.
Other Desired Experience:
· Process Engineering
· Bioreactors, media and harvest vessels, filtration systems, chromatography systems, clean utilities
· Management of process development activities
· Process facility design and construction: clean rooms, labs, environmental control systems for classified spaces, cold chain storage, waste processing
· Single use biomanufacturing systems
· Continuous Process Verification (CPV) (using Minitab or other statistical software)
· Process performance qualification (PPQ)
· Deviation and CAPA investigations
· Experience with biomanufacturing processes
· Program/Project Management
· Project planning and estimating
· Schedule development and execution
· Issue tracking and resolution
· Establishing metrics and leading team to achieve performance goals
· Facilitating meetings and workshops
· BSc or MSc in a relevant engineering or science field, or equivalent experience
· Customer-service focused
· Excellent oral and written communication skills in English. German and/or French is a plus.
· Able to travel domestically and internationally if required
· Able to work in the US without sponsorship now or any time or in the future