CSV Lead Instrument Software Validation

CSV Lead Instrument Software Validation - 25-05061
100% Remote | CAD or USA
6+ Mths Duration
W2/T4 or C2C

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.
NTT DATA's Client is currently seeking a CSV Lead Instrument Software Validation to join their team in Calgary, Ontario (CA-ON), Canada (CA).

Job Description:
Experience Level: 5-7 Years
Job Description:
We are seeking an experienced Instrument Software Validation Project CSV Lead to join our team. The ideal candidate will have a strong background in European regulations compliance, GxP/Validation expertise, and business analysis. This role is critical for ensuring the successful validation of our instrument software in compliance with regulatory standards.

Key Responsibilities:

• Lead and manage the Computer System Validation (CSV) activities for instrument software projects, ensuring compliance with European regulations, including EMA guidelines.
• Develop and execute validation plans, protocols, and reports in accordance with GxP requirements.
• Collaborate with cross-functional teams to gather and analyze business requirements, translating them into technical specifications and validation deliverables.
• Oversee the validation of infrastructure and instrumentation systems, ensuring they meet regulatory and business requirements.
• Provide expertise in lab systems and clinical trial processes, ensuring that validation activities align with industry standards and best practices.
• Conduct risk assessments and impact analyses to identify and mitigate potential validation issues.
• Maintain comprehensive documentation of validation activities, ensuring traceability and compliance with regulatory standards.
• Stay updated with the latest regulatory changes and industry trends to ensure ongoing compliance and continuous improvement.

Required Skills and Qualifications:

• Bachelor's degree in a relevant field such as Computer Science, Engineering, or Life Sciences.
• 5-7 years of experience in computer system validation, with a focus on instrument software.
• Strong knowledge of European regulations, including EMA guidelines.
• Expertise in GxP/Validation processes and requirements.
• Proven experience as a Business Analyst, with the ability to gather and analyze requirements and translate them into technical specifications.
• Experience with infrastructure and instrumentation systems.
• Familiarity with lab systems and clinical trial processes.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications:

• Advanced degree in a relevant field.
• Certifications in computer system validation or related areas.
• Experience with regulatory inspections and audits.
• Knowledge of Agile methodologies and experience working in an Agile environment.

About NTT DATA:
Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this remote role is $50 to $59/hr CAD.  This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on several factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications. This position may also be eligible for incentive compensation based on individual and/or company performance.
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.

NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com

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