Senior CSV Engineer

CAI Overview:

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 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. Key Responsibilities:

• Major Area 1

his position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
Prepares/reviews validation documentation related to projects/change controls.
Manages change controls and other compliance related tasks e.g. non-conformances.
Participates in the review of current and future CSV procedures and polices
Analyses the results of testing and determines the acceptability of results against predetermined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Participates in regulatory audits and communicates company's computer validation policies.
Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.
Manages projects and prepares status reports using Microsoft project and other communication tools.
May supervise, lead, or manage lower-level personnel.Agent expected skills: CSV , IT, GMP based knowledge.
Demonstrated ability with information technology delivery for regulated businesses highly desirable, specifically in supporting IT delivery or transition in manufacturing or integrations. Leadership experience in a matrixed environment preferred.
Ability to balance the long-term ("big picture") and short-term implications of individual decisions
Experience In Delivery Of Successful Enterprise Level IT Programs

Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Suitable candidates must be available for travel throughout Italy and some European travel may be required.
La selezione rispetta il principio delle pari opportunità (l. 903/77)
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 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.

Build Talent
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.

Achieve Results with People
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.

DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO

La selezione rispetta il principio delle pari opportunità (l. 903/77)

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.