CAI is looking for an individual with a range of experience in the areas of commissioning, qualification, and validation to join our team in Japan. Experience in the pharmaceutical, medical device or biotechnology industries is required.
CAI was established in 1996, it has grown year over year to more than 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.
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.
At 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.
We strongly believe that 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 Senior CQV Engineer to join our growing operations in Japan. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. He/She is responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a Senior CQV Engineer in CAI is to:
· Independently develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
· Responsible for protocol writing and execution (field verification), and development of summary reports at client sites. Other responsibilities include planning / coordinating work and directing small teams in document development and / or execution.
· BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
· 5 – 12 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
· Provide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
· Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
· High attention to detail
· Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
· Ability to work independently, while quickly building and nurturing a project team
· Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
· Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns
· Experience in planning / directing C&Q activities
· Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
· Familiarity with Baseline Guide 5 (Second Edition) a plus
· Expertise in Microsoft Word and Excel
· Excellent oral and written English are required.
· Able to travel if required
In return for your skills and knowledge, CAI offers a wide range of benefits including:
· Competitive Salary
· Continuing education (internal and external)
· Opportunities to work on cutting edge projects in a highly evolving field