Computer System Validation Engineer

Cagents; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

CAI is seeking a Computer Systems Validation (CSV) Engineer to develop and execute validation protocols and scripts, identify gaps, and direct plans for resolution in a GMP environment. You will write GxP validation documentation including URS, FRS, RTM, and reports and ensure data integrity per 21 CFR Part 11 guidelines.

Ideal candidates hold a BS in Computer Science or Engineering with 2-7 years of CSV experience and exposure to GMP, aseptic processes, MES, DeltaV, and PI.

Competenze

• 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.

Mansioni

• The 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
• Lead validation activities to ensure compliance and data integrity in GMP environments

Conoscenze

CSV validation

GxP knowledge

Data integrity

GMP experience

English communication

Travel willingness

Formazione

BS in Computer Science or Engineering

Strumenti

MES

DeltaV

PI

PAS-X

Syncade

FactoryTalk

Descrizione del lavoro

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.

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

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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.

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