Computer System Validation Engineer - Pharma

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.
We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
We serve each other
We serve society
From the beginning, we’ve challenged ourselves to do what others wouldn’t. For us, operational readiness isn’t simply a goal. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. 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.
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
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.
Excellent oral and written communication skills in English/Fluent in English
La selezione rispetta il principio delle pari opportunità (l. 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
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.
Inspires and coaches others to achieve beyond their own expectations and develop a winning mindset.
Provides feedback, coaching, and guidance where appropriate to enhance others’ skill development.
Fosters a sense of energy, ownership, and personal commitment to the work.
Inspires others to stretch beyond what they thought they could do.
Creates an environment in which performance excellence is rewarded.
Develops and drives a safe and inclusive work culture.
Takes well-reasoned stands on important issues and always leads with integrity.
Develops breakthrough ideas, safe working processes, initiatives, and business ventures.
DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO