QA​/Validation Engineer

Overview

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.

• 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 surpassing expectations. 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.

Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations / Environmental Monitoring etc.

Performs Batch Disposition preparation, Batch record review, Certification process oversight.

Strong cGMP and regulatory requirement understanding.

Experience in Trackwise.

Support all quality and compliance requirements for and leading to commercial manufacturing.

Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.

Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.

Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.

Ensure the highest Quality, Compliance and Safety standards.

Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.

Excellent oral and written English are required.

Suitable candidates must be available for travel throughout Italy and some European travel may be 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.

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.

Focus on Customers.

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.

Lead Execution.

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…