Computer System Validation Engineer

CAI 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.

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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.

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 assignmen