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 CQV Lead to join our growing operations in the Netherlands. The role of a CQV Lead in CAI is to:
· Organize and review daily activities of the CQV Engineers assigned to the project
· Ensure site project execution is undertaken in safety and in compliance with project guideline and safety standards
· Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
· Direct reporting to Project Manager/Country Manager
· Identify and onboard CQV consultants with the right experience in Commissioning and Qualification
· Support onsite and offsite activities, such as: FATs, SATs, Executions and System Walkdowns
· Track progress of C&Q activities as required.
· Support our growth and new business opportunities within the Netherlands
· Coordinate support during C&Q execution
· Time and budget Management
· Resource planning and management
· BS or MS in a relevant science or engineering field, or equivalent
· 6 + years of Commissioning, Qualification, Validation and Compliance experience in the Life Sciences or Regulated Industries; Sound technical knowledge of EU and global regulatory requirements. Proficient in cGMP standards.
· Experience in collaborating and leading Commissioning, Qualification and Validation deliverables for one or Multiple Projects
· 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.
· Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Able to travel domestically and internationally if required.