CSV Engineer

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, 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 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. DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO La selezione rispetta il principio delle pari opportunità (l. 903/77)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, 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. 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 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 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. DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO La selezione rispetta il principio delle pari opportunità (l. 903/77)