Validation Engineer with expertise in isolators and VHP Cycle development.

Milano - Italy

Monthly Salary: Not Disclosed

Posted on: 20 days ago

Vacancies: 1 Vacancy

Job Summary

Key Responsibilities:

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.

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.

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.

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.

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 surpassingexpectations. From the beginning weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were 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.

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 peoples 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.

Key Responsibilities:1. Major Area 1We 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 verif...