Validation Specialist / Validation Engineer

About the Role/Project

The Consultant is typically acting as Validation Consultant. Either for the client or for NNIT. Key responsibilities are ensuring compliance with regulatory requirements, company Computer Systems Validation (CSV), Lifecycle procedures, and Data Integrity requirements.

The Consultant is responsible for preparing Validation Plans, Specifications, and Qualification documentation, so the total IT delivery meets customer needs and regulatory requirements. The Consultant provide input to project milestones and reporting.

Duties and Responsibilities:

• Proactively fulfill the role as Consultant in small to medium complex Life Sciences IT projects
• Independently prepare validation documents
• Assist the Project/Program Manager, and the Validation Project Validation Lead, Quality Project Lead, or Project Validation Manager with quality and risk management issues, conduct risk management assessments/workshops, and provide input to validation and test strategies
• Contribute in Quality Activities for Computer System Validation (CSV) projects/activities (incl. areas related to Data Integrity/ER)
• Participate in small to medium complex E-2-E Validations
• Review IT project and operations documentation; ensure that process requirements are met according to the controlling QMS
• Identifying and implementing process improvements
• Prepare testing activities – IQ, OQ, PQ incl. deviation handling and reporting (supported)

Qualifications:

• 3-5 or more years working in a Consultant/Quality role
• Life Sciences biotech / pharmaceutical experience
• Experience with working with validated computer systems (CSV), GxP and Quality Management
• Good knowledge of most phases of the V-model/Agile delivery methodology, and ISPE GAMP5 guidelines
• Experience with creating and reviewing documentation
• Consultancy mindset
• Commercial mindset
• Strong communication skills, both verbal and written
• Ability to work both independently and with teams at various levels in the organization
• Ability to work in a very dynamic environment with a clear sense of urgency
• Excellent organizational skills and attention to detail and accuracy

Nice to have:

• Experience in quality management of IT applications or infrastructure, maybe from working in the Life Sciences segment
• ISPE/ECA GAMP5 training or certification
• ISTQB Foundation Certification
• Veeva certification
• MS AzureDevOps AZ900 course
• SAFe Agile Foundation
• HP ALM or TLMS Testing
• MS AzureDevOps AZ900 training
• MES (Manufacturing Execution System (MODA-ES and other software related to MES))
• Knowledge about Validation Lifecycle Management Systems (VLMS), e.g. Kneat, ValGenesis
• Experience with Test Automation tools, e.g. LeapWork, TOSCA, UIPath, other
• Experience with Pharmaceutical Production or IT Laboratory
• Experience with Track & Trace/Serialization
• IT Infrastructure experience or knowledge

WHO WE ARE

NNIT is a fast-growing IT company with ambitious goals and 2,400 employees. At NNIT, you can make your mark on some of the most challenging projects in the industry, on our journey forward as a company, and on your own career. You'll work in agile teams with other passionate people in a culture with room for independent thinking and individual responsibility.

We supply IT services to large enterprises that demand high levels of quality and security, and we take on the responsibility for our clients' IT as if it were our own. We live our values every day, so you should be able to see yourself in them. We are: Conscience driven. Value adding. Open and honest.

Our everyday work is characterized by an open and honest atmosphere, and we put emphasis on creating a challenging yet fun working environment. We pay significant attention to job satisfaction, and personal and professional development.

On top of the statutory benefits stipulated by the local law, NNIT DLSP employees enjoy the following benefits upon joining:

• Competitive Compensation
• 13th Month Pay
• Performance Bonus
• Rice Subsidy
• Communication Allowance
• Fitness Allowance
• Clothing and Laundry Allowance
• Medical Allowance (Employee and Dependent)
• HMO (Employee and Dependent/s)
• Life Insurance
• Vacation Leaves and Sick Leaves (convertible to cash)
• Emergency Loan
• Year-End Gift
• Wedding Gift
• First Baby Gift
• Breakfast once a week
• Fruits, Snacks / Well-stocked pantry
• Flexible Working Hours
• Hybrid set up even before the pandemic

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