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 Validation Engineer – Senior I to join our growing operations in India. This role requires a strong understanding of cGMP regulations, computer system validation (CSV), and Commissioning & Qualification (C&Q) principles. The role of a Validation Engineer – Senior I in CAI is to:

 

·        Independently develop, implement, and manage CSV, CQV, and other validation projects in accordance with regulatory requirements (e.g., FDA, ICH guidelines) and with a strong focus on safety.

·        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 the development and implementation of C&Q SOPs and policies for client projects. 

·        Support review/qualification of equipment design

·        Review, and revises a variety of installation, operation, and performance qualification/verification related documents, including 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 activities as required.

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

·        Collaborate effectively with cross-functional teams (engineering, quality assurance, IT, equipment vendors) to ensure smooth project execution.

·        Allocate project resources for efficient execution of project deliverables.

·        Maintain accurate and complete C&Q documentation, including protocols, reports, and certificates.

·        Stay current with cGMP regulations, ICH guidelines, and industry best practices for CSV and C&Q.

·        Train and mentor junior staff members on C&Q procedures.

·        Identify and propose process improvements for C&Q activities.

 

Position Requirements:

·        Bachelor’s degree in engineering, Science, or a related field.

·        Proven experience in managing and executing CSV, CQV, and other validation projects.

·        Strong understanding of regulatory requirements for validation (e.g., FDA 21 CFR Part 11, ICH Q9).

·        Excellent knowledge of validation methodologies (IQ, OQ, PQ) and test protocols.

·        Experience with GAMP (Good Automated Manufacturing Practice) principles, validation software or data management systems a plus.

·        Outstanding oral and written communication skills, make points effectively.

·        Strong problem-solving abilities.

·        A strong customer-service focus.

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

·        Proposes clear technical solutions to challenging issues.

·        Leadership: Solicits opinions of others; takes decisive position to meet team objectives.

·        Encourages teamwork by using people's strengths and acknowledging contributions.

·        Project Management: Can reliably create resource loaded schedules.

·        Assumes personal responsibility for specific, straightforward components of larger projects.

·        Takes personal responsibility, with guidance, for small, straightforward projects, involving coordination with others.

·        Respect for others, can do attitude.

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