Validation Engineer with expertise in isolators and VHP Cycle development.

1.            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.

Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.

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 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.

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 advancement. We’re not interested in how it used to be done. We’re obsessed with how Apply Commercial Insights

Demonstrates understanding of financial      and economic levers that impact business performance and deploys them to      improve short- and long-term results.

Promotes best-in-class risk awareness      and reviews risk management performance on a continuing basis.

Draws appropriate conclusions from      financial reports and analyses to identify and evaluate major strategic      priorities and investments.

Fosters a customer-focused environment.

Identifies and anticipates customer      requirements, expectations, and needs.

Creates systems and processes that make      it easy for customers to do business with CAI.

Maintains accountability throughout the      organization and encourages managed risk taking.

Delegates assignments to the lowest      appropriate level and keeps people focused.

Monitors progress and redirects efforts      when goals change or are not met.

Ensures people have resources,      information, authority, empowerment, & support needed to achieve      objectives.

Influence and Engage Others

Identifies the agendas, concerns, and      motivations of others.

Negotiates persuasively to create      win-win solutions for all parties.

Cultivates networks across the      organization to garner support and create a foundation for future      influence.

Inspires and coaches others to achieve      beyond their own expectations and develop a winning mindset.

Provides feedback, coaching, and      guidance where appropriate to enhance others’ skill development.

Shapes roles and assignments in ways      that leverage and develop people’s capabilities.

Develops successors and talent pools to      ensure availability of future talent.

Promotes the recruitment, advancement,      and success of the best people from diverse backgrounds.

Fosters a sense of energy, ownership,      and personal commitment to the work.

Inspires others to stretch beyond what      they thought they could do.

Encourages others to set challenging      goals and high standards of performance.

Creates an environment in which      performance excellence is rewarded.

Challenges self and others to learn and      develop to improve capabilities.

Lead Courageously and Safely

·       Develops and drives a safe and inclusive work culture.

Takes well-reasoned stands on important      issues and always leads with integrity.

Makes tough people and business      decisions and challenges “the way it has always been done.”

Develops breakthrough ideas, safe      working processes, initiatives, and business ventures.