Validation Engineer Senior

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:

1.            Major Area 1

Provides knowledge and experience in

Validation approaches applied to Systems

and processes

- Manage Deviation/ Change Control applied

to validation study

- Experience in Process Validation, cleaning

validation, equipment qualification, filter

validation

- Support generation of C&Q Procedures for

client projects.

- Support CQV review/qualification of

equipment design

- Review, and revises a variety of installation,

operation, and performance

qualification/verification related documents,

including any of all of the following: SOPs,

CAI Requisition Request

validation/verification master plans,

guidelines and execution plans.

- Strong cGMP and regulatory requirement

understanding.

- 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 validation

Other: Project Management: Can reliably create

resource loaded schedules.

· Assumes personal responsibility for specific,

straightforward components of larger projects.

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

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