Validation Engineer expertise in isolators and VHP Cycle development

Validation Engineer with expertise in isolators and VHP Cycle development.

Italy / South Europe / Full Time Key Responsibilities

• Develop 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.
• Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
• Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge.
• Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.

• 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 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.
• Creates strategies to balance short-term requirements with long-range business plans.
• Pursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats.
• Aligns strategic priorities of own area with current direction and strategic priorities of the broader organization.

Are You Ready?

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.

Our approach is simple because our Purpose informs everything we do:

· We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At 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

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassingexpectations. 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…