Validation Engineer – Isolators and VHP Cycle Development 3 days ago – Be among the first 25 applicants Key Responsibilities
Major Area 1
We are now seeking a Validation Engineer to join our growing operations in Italy. The Validation 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. The role of a Validation Engineer in CAI is to: support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. This includes isolator qualification protocol execution and reporting, VHP cycle development, and GMP based knowledge. Position Requirements High attention to detail Ability 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. Minimum 3 – 5 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, P&IDs;, IQ/OQ/PQs, generation & execution, etc. Provide cGMP leadership and guidance for the integration and delivery of VALIDATION services for our Life Sciences clients. Excellent technical problem‑solving and troubleshooting skills, with solid knowledge of typical project technical issues and deadlines. Ability to work independently, while quickly building and nurturing a project team. Managing the C&Q; documentation and execution lifecycle from SLIA generation through to OQ completion. Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ Executions and System Walkdowns. Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience. Familiarity with Baseline Guide 5 (Second Edition) a plus; expertise in Microsoft Word and Excel. Excellent oral and written English are required. Suitable candidates must be available for travel throughout Italy and some European travel may be required and a valid permit to stay for Italy. Company Overview (optional) CAI 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. We act with integrity, serve each other, serve society, and work for our future. La selezione rispetta il principio delle pari occasione (l. 903/77). Seniority level Not Applicable Employment type Full‑time Job function Quality AssurancePharmaceutical Manufacturing #J-18808-Ljbffr