Computer System Validation Specialist

 
 

Capgemini’s Cloud Infrastructure Services unit is a global team of technology experts and domain specialists that helps businesses from all around the world extract maximum business value from their IT investment and facilitates their journeys to the cloud.
In addition to facilitating journeys to the cloud, we support businesses by providing services such as helpdesk services (human and AI powered), network access and maintenance, hosting and maintaining applications, IT operations and much more. We do all this in 24 languages from 4 locations in Poland.
Join our global team and be part of technology transformation. 
 

We are currently looking for a Computer System Validation (CSV) Specialist to join our growing Cybersecurity practice.
To be successful in the role you will need some previous CSV experience to be able to drive CSV results with Business stakeholders, Development team and coordinate with Test team to review and complete assigned validation tasks and deliverables on multiple GxP systems.

 

Main requirements:

• FDA (Food & Drug Administration) CSV (Computer Systems Validation) SME
• Experience in FDA 21 CFR 11 testing compliance must-have
• Participates in design and implementation of QA test strategies
• Hand-on experience in CSV process compliance
• Knowledge of SQA process compliance
• A team player with an ability to push forward CSV compliance agenda in JnJ while educating the teams
• Work with team, train them on CSV compliance and testing methodology
• Ability to communicate effectively both orally and in writing
• Strong analytical, problem-solving and conceptual skills
• Excellent organizational skills; attention to detail
• Ability to identify and resolve project issues effectively and efficiently

 
Candidates should be flexible / willing to work across this delivery landscape which includes and not limited to Agile Applications Development, Support and Deployment.
 

Your role as a CSV Specialist will involve:

• Acting as a control point for validation documentation for FDA regulated systems
• Consultation regarding quality and compliance with FDA regulations - CFR 21 (Part 11)
• Training delivery to employees on FDA and quality related queries
• Working in highly regulated environment
• Coordination of various quality and compliance requirements
• Providing variance reports
• Supporting deviation management
• Willingness to travel internationally (up to 30%) to our clients' locations is needed

 

Our Cybersecurity team is managing projects such as Cybersecurity Client Experience Center, Cloud Security Services, Managed Security Services Platform and many, many more.
Capgemini Cybersecurity practice is a global Microsoft and Amazon partner which gives us large training and certification benefits to develop cloud security skills.
We also offer wide certification opportunity covering: (ISC)2, ISACA, CompTIA and many more.
By joining us you will become a part of independent team of professionals focusing on results in dynamic, fast paced projects environment, specifically in area Cloud Security. We promise you will never be bored with monotonic, day to day operational tasks. Instead, you will be tackling challenges requiring analytical and creative thinking. Our strategy assumes growth through which we will bring an accessible set of consulting skills to the market. We strive for our consultants to be well balanced between business and technology areas.
 
 

Atmosphere

• Working with great people and in legendary atmosphere
• No formal dress code
• Annual family picnics
• Unforgettable integrational events
• Employee volunteering opportunities and interesting CSR projects
• We value and respect diversity in terms of gender, nationality, roles, age, interests
• Internal celebration initiatives: Children's Day, St. Nicholas Day and many more
• Supporting employees' hobbies: Business Run, e-sport games, basketball, volleyball

 
Development

• Development in expert or leader competencies
• Broad training offer with possible co-funding
• Access to MIT Sloan Management Review Polska knowledge base
• Introduction plan for new employees and Buddy Initiative
• A wide range of instructor-led and e-learning trainings
• Co-financing for post-graduate studies and courses
• Many companies under one roof / internal headhunters
• Internal development events: conferences, meetings, communities
• Education First platform for learning English online

 

 

Benefits

• Bonuses, including those for new employees recommendation
• Additional life insurance
• Access to MyAudiobooks - Entertainment and personal growth in audio version
• Attractive package of extra benefits of your choosing (fitness, gym, cinema, etc.)
• Disability inclusion, assistive technologies, reasonable accommodations
• Stay Well helpline to support the emotional and mental aspects of well-being
• Private medical care for you and your family
• Bicycle parking and carpooling options
• Free coffee, water, milk and wide range of teas
• Anti-smog plants in offices
• Car leasing