Senior Validation Engineer - CQV/CSV

About CAI

CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 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.

 

Are you ready?

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.

 

Requirements include:

 

We are now seeking a Validation Engineer (Staff II) to join our growing operations in India. In this role, you will play a key role in supporting our Commissioning, Qualification, and Validation (CQV) processes, ensuring the safe and efficient operation of our equipment and facilities. The role of a Validation Engineer – Staff II in CAI is to:

 

·        Perform CSV, CQV, and other validation activities with a direct regard for Safety and in accordance with regulatory requirements (e.g., FDA, ICH guidelines).

·        Develop and execute CQV/ CSV protocols and plans for pharmaceutical facility/ systems.

·        Perform risk assessments, gap analyses, and impact assessments to determine the appropriate C&Q approach.

·        Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems

·        Support generation of C&Q/ CSV Procedures for client projects. 

·        Support CQV/ CSV review/qualification of equipment design

·        Review, and revises a variety of installation, operation, and performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans.

·        Supports scoping / planning of commissioning spares and consumables.

·        Deliver the C&Q/ CSV activities as required to meet the schedule.

·        Track progress of C&Q/ CSV activities as required.

·        Support execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.

·        Coordinate with project contractors and equipment vendors to execute required tests.

·        Allocate project resources for efficient execution of project deliverables.

·        Coordinate support during C&Q execution.

 

Position Requirements:

·        A bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences, with a minimum of 4+ years of related experience in the Pharmaceutical/Life Sciences industry. Relevant experience can substitute for education.

·        Essential experience in a GMP (Good Manufacturing Practice) environment, Regulatory requirements.

·        Outstanding oral and written communication skills.

·        Strong problem-solving abilities.

·        A strong customer-service focus.

·        Willingness and flexibility to travel throughout Europe and potentially internationally, if required.

 #Li - MD1