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Computer System Validation Engineer
Job Location:
Yearly Salary:
Posted:
29 September 2026 (4 days ago)
Posted:
Application Deadline:
27 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 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 it will be done.
It is absolutely necessary in order to apply to be a European citizen or to hold a valid residence permit for Europe.
Key Responsibilities:
1. Major Area 1
The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts identify gaps and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments plans URS FRS RTM and summary reports.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
2-7 years experience with Computer systems validation
2 years experience working in a GMP environment
aseptic process knowledge
filling line CSV and Automation experience
Experience in Data Integrity with GAMP and 483 compliance consent decree experience deep 21CFR Part 11 experience is highly desired
Experience in biotech and pharma is preferred over medical device
Experience with MES Delta V PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell GE Emerson ABB Werum Siemens Honeywell and their associated platforms PAS-X Syncade FactoryTalk PharmaSuite Control Logix PLM Simatic iFix Wonderware Siemens etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as 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 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)
34400 - 45800 a year
The compensation package offered ranges from 34000 to 45000 gross per annum (Gross Annual Salary). The final salary within this range will be determined according to the candidates technical competencies and relevant professional experience.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. 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.
Required Experience:
IC
About Company
CAI helps organizations leverage technology, people, and processes to solve business problems, enable savings, and spur innovation.
