Job Description

About CAICAI 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.Meeting a Higher StandardOur 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:\xc2\xb7 We act with integrity,\xc2\xb7 We serve each other,\xc2\xb7 We serve society,\xc2\xb7 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:\xc2\xb7 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.\xc2\xb7 Develop and execute CQV/ CSV protocols and plans for pharmaceutical facility/ systems.\xc2\xb7 Perform risk assessments, gap analyses, and impact assessments to determine the appropriate C&Q approach.\xc2\xb7 Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems.\xc2\xb7 Support the development and implementation of C&Q SOPs and policies for client projects.\xc2\xb7 Support review/qualification of equipment design\xc2\xb7 Review, and revises a variety of installation, operation, and performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines and execution plans.\xc2\xb7 Supports scoping / planning of commissioning spares and consumables.\xc2\xb7 Deliver the C&Q/CSV activities as required to meet the schedule.\xc2\xb7 Track progress of C&Q activities as required.\xc2\xb7 Support execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.\xc2\xb7 Collaborate effectively with cross-functional teams (engineering, quality assurance, IT, equipment vendors) to ensure smooth project execution.\xc2\xb7 Allocate project resources for efficient execution of project deliverables.\xc2\xb7 Maintain accurate and complete C&Q documentation, including protocols, reports, and certificates.\xc2\xb7 Stay current with cGMP regulations, ICH guidelines, and industry best practices for CSV and C&Q.\xc2\xb7 Train and mentor junior staff members on C&Q procedures.\xc2\xb7 Identify and propose process improvements for C&Q activities.Position Requirements:\xc2\xb7 Bachelor's degree in engineering, Science, or a related field.\xc2\xb7 Proven experience in managing and executing CSV, CQV, and other validation projects.\xc2\xb7 Strong understanding of regulatory requirements for validation (e.g., FDA 21 CFR Part 11, ICH Q9).\xc2\xb7 Excellent knowledge of validation methodologies (IQ, OQ, PQ) and test protocols.\xc2\xb7 Experience with GAMP (Good Automated Manufacturing Practice) principles, validation software or data management systems a plus.\xc2\xb7 Outstanding oral and written communication skills, make points effectively.\xc2\xb7 Strong problem-solving abilities.\xc2\xb7 A strong customer-service focus.\xc2\xb7 Willingness and flexibility to travel throughout APAC/Europe and potentially internationally if required.\xc2\xb7 Proposes clear technical solutions to challenging issues.\xc2\xb7 Leadership: Solicits opinions of others; takes decisive position to meet team objectives.\xc2\xb7 Encourages teamwork by using people's strengths and acknowledging contributions.\xc2\xb7 Project Management: Can reliably create resource loaded schedules.\xc2\xb7 Assumes personal responsibility for specific, straightforward components of larger projects.\xc2\xb7 Takes personal responsibility, with guidance, for small, straightforward projects, involving coordination with others.\xc2\xb7 Respect for others, can do attitude.#Li-MD1\xe2\x82\xb96,28,700 - \xe2\x82\xb98,02,500 a yearGr15(ST2) - Min628000-685900-802500Benefits- Competitive Industry standard/MNC remuneration offered to the right candidate.- 25 working days paid annual leave- Paid sick leave as per Company policy.- Medical Insurance for self and family- Personal accident insurance coverage for staff- All official travel, accommodation and transportation are taken care by CAI India- Annual discretionary bonus- Excellent training opportunities#Li-MD1We 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 (FCO).#Li-MD1

CAI