About CAI:
CAI is a 100% employee-owned company established in 1996, with over 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.
Our approach is centered around putting our clients' interests first, ensuring everything meets their standards, and taking the necessary steps to achieve that goal.
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, everyone's success contributes to the team's overall success; we work diligently to accomplish shared goals. This culture of teamwork is reflected in our values of Team Before Self, Respect for Others, and a can-do attitude, which have enabled us to grow exponentially.
As part of CAI, you'll have access to cutting-edge technologies in the advanced medicine space. You'll collaborate with recognized subject matter experts, enabling you to make a significant impact on bringing lifesaving therapies to market. Our commitment to your growth includes hands-on certifications and professional training, ensuring you're equipped to excel in your role. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Key responsibilities include:
1. Leading Commissioning, Qualification, Validation activities with a strong focus on Safety.
2. Managing C&Q documentation and execution lifecycle, from SLIA generation to OQ completion.
3. Developing C&Q Procedures for projects.
4. Approving TOPs.
5. Coordinating the planning of commissioning spares and consumables.
6. Delivering C&Q activities to meet schedule requirements.
7. Tracking progress of C&Q activities as needed.
8. Preparing Qualification Summary Reports (QSR) and managing Requirement Traceability Matrix (RTM).
9. Executing Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
10. Managing aspects of C & Q verification, such as Change Controls, Management of Contractors and Vendors, document control, punch list management.
11. Coordinating with project contractors and equipment vendors to execute required tests.
12. Allocating project resources for efficient execution of project deliverables.
13. Providing support during C&Q execution.
To be successful in this role, you will need:
* A BS or MS degree in a relevant science or engineering field, or equivalent experience.
* At least 3 years of experience in CQV SME roles for life sciences – Clean Utilities/Filling experience is preferred.
* Excellent oral and written communication skills.
* Excellent problem-solving skills.
* A customer-service focused mindset.
* Proficiency in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
* Ability to travel domestically and internationally if required.
CAI is an equal opportunity employer, proud to employ veterans and promote a diverse culture in our workplace. We believe that diversity is a strength for our global company, and we pledge to operate in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not exhaustive, and you may be asked to perform other duties.