The Validation Process Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are 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 in a relevant science or engineering field, or equivalent years of hands on experience
4-8 years’ experience performing commissioning and / or qualification activities in a regulated industry
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
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
Experience in planning / directing C&Q activities a plus
Excellent oral and written English is required
Able to travel domestically and possibly internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in the future
CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with 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 (our core values). That is how we have grown exponentially.
Our full time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.