Commissioning, Qualification, & Validation Engineer
Business Areas Commissioning & Qualification /
CAI is a 100% employee-owned company established in 1996 that
has grown to nearly 600 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.
Please check CAI out on Glassdoor to get a better perspective on
our culture. We are extremely proud that our employee owners and
others have given us so many 5-star ratings.
Meeting a Higher Standard
Our approach is simple; we put the clients interests first, we
do not stop until it is right, and we will do whatever it takes to
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 persons success is everyones
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
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.
CAI CQV Engineers 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 patients. 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 employees benefit from our
role as the leading commissioning / qualification firm in the
The CQV 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.
BS or MS in a relevant science or engineering field, or
2-15 years experience performing commissioning and / or
qualification activities in a regulated industry.
Ability to generate commissioning and qualification protocols
for multiple types of compounding equipment, integrated filling
machines, closed stopper processing and clean utility
Cycle Development for SIP and CIP
Execution of IQ, OQ and PQ protocols
Development of commissioning and qualification plans, risk
assessments including SLIA and PFMEAs
Familiar with FDA, EMEA and PICS regulatory requirements
Ability to multi-task and take initiative to accomplish assigned
tasks accurately by established deadlines.
Ability to work independently, while supporting other team
Excellent technical problem-solving and troubleshooting
High attention to detail.
Expertise in Microsoft Word and Excel
Familiarity with ISPE Baseline Guide 5 (Second Edition) a
Excellent oral and written English is required
Able to travel domestically and possibly internationally if
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time or in
We are an equal opportunity employer; we are proud to employ
veterans and promote diversity and inclusion in our workplace.
Diversity is a strength for our global company.We pledge that CAI
will be operated in a way that is fair and equitable to all our
employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked
to do other duties. CAI will also consider for employment qualified
applicants with criminal histories in a manner consistent with the
requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance