Validation Engineer

h3CAI Overview /h3 pCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years. /p h3Are You Ready? /h3 pOur approach is simple because our Purpose informs everything we do: /p ul liWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. /li /ul pAt CAI, we are committed to living our Foundational Principles, both professionally and personally: /p ul liWe act with integrity /li liWe serve each other /li liWe serve society /li liWe work for our future /li /ul pAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing /p pexpectations.

From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity.

For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement.

We’re not interested in how it used to be done. We’re obsessed with how it will be done. /p pIt is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe. /p pWe are only looking for candidates with experience in the pharmaceutical industry, specifically within a GMP-regulated environment. /p h3Position Description /h3 pWe are now seeking a CQV Engineer to join our growing operations in Italy.

The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site. /p pThe role of a CQV Engineer in CAI is to: /p ul liSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. /li liResponsible for protocol writing and execution (field verification), and development of summary reports at client sites. /li /ul h3Position Requirements /h3 ul liHigh attention to detail /li liAbility to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience /li liMinimum 4 – 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry.

Ideally, you will already have experience in facilities and equipment startup, walk downs troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, PIDs, IQ/OQ/PQs, generation execution, etc. /li liProvide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients. /li liExcellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues /li lideadlines /li liAbility to work independently, while quickly building and nurturing a project team /li liManaging the CQ documentation and execution lifecycle from SLIA generation through to OQ completion. /li liSupport onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns /li liProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. /li liFamiliarity with Baseline Guide 5 (Second Edition) a plus /li liExpected

skills

Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge /li liExpertise in Microsoft Word and Excel /li liExcellent oral and written English are required. /li liAvailable for travel in Italy and abroad 100%. /li /ul pbThe compensation package offered ranges from €45.000 to €57,000 gross per annum (Gross Annual Salary).

The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience. /b /p pLa selezione rispetta il principio delle pari opportunità (l. 903/77) /p p€45,800 - €57,000 a year /p pbThe compensation package offered ranges from €45.000 to €57,000 gross per annum (Gross Annual Salary).

The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience. /b /p

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