CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 600 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 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. 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 looking for Process Engineers to join our growing organization.
The role of a Process Engineer in CAI is to:
· Manage and support project delivery process, C&Q, and FPX standards to drive deployment.
· Monitors the status of programs and project, provides technical interpretation and expertise.
· Lead engineering execution of projects and initiatives in the platform, for strategic projects and across sites.
· Generates capital equipment appropriations required for new process implementation or facilities and controls expenditures to ensure compliance with timing and budget requirements.
· Ensures attainment of project and program schedules, budgets, procedures and revenues by developing and monitoring the budget and approval process.
· Ensures the documentation of project and program activities and work.
· Manage compliance with EHS&S policies and procedures
· Coordinate with Technical Operations group to ensure alignment on technical standards and project execution for technical transfer projects/NPI
· Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM)
· Execution of Design reviews, shakedown, FAT's, IQ, OQ, PQ activities.
· Coordinate with project contractors and equipment vendors to execute required tests.
· BS or MS in a relevant science or engineering field, or equivalent with at least 5 years’ experience in a GMP environment
· Maintenance experience within a process or pharmaceutical cGMP regulated environment.
· Experience of standard methodologies in preventive maintenance, condition monitoring, maintenance planning, Maintenance engineering, RCM or FMECA.
· Experience in failure analysis.
· Experience of Delta V, PLC and SCADA systems
· Excellent oral and written communication skills
· Excellent problem-solving skills
· 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.