CSV Consultant

2 months ago


Singapur, Singapore NNIT Full time
Job Title: CSV Consultant

At NNIT, we are seeking a highly skilled CSV Consultant to join our team. As a CSV Consultant, you will be responsible for providing Computerized System Validation (CSV) and Computerized System Assurance (CSA) consulting services to pharmaceutical and medical device manufacturing companies.

Responsibilities:
  • Manage the system design life cycle (SDLC), including risk, deviation, and change management.
  • Develop and execute FAT/SAT test scripts, qualification protocols, and reports based on industry best practices.
  • Review, analyze, and evaluate system functions and processes to deliver validation deliverables.
  • Develop approaches using science- or risk-based methods that meet regulatory expectations.
  • Lead CSV services in one or more of the following disciplines: production/manufacturing systems, laboratory instruments/equipment/enterprise systems, engineering/automation, or emerging technologies.
Requirements:
  • Bachelor's degree in a technical discipline, such as engineering, science, or IT.
  • At least 2 years of experience performing CSV activities.
  • Experience in engineering/process automation, such as DCS, Historian, MES, and/or PLC, is viewed favorably.
  • Ability to communicate quality and risk-related concepts to technical and non-technical audiences.
  • Good written and oral communication skills, presentation, and data analytics.
  • Demonstrated ability to work as a team player and independently.
  • Foundational understanding of ICH Q7/Q9, 21 CFR Part 11, EU Annex 11, and regulatory requirements.
What We Offer:
  • Consulting roles for pharmaceutical and medical device clients in strategically relevant projects.
  • Opportunity to develop skills and deliver projects in both technical and qualification/validation scope.
  • Opportunity to take on responsibility and help shape our organization.
  • Excellent career development and growth opportunities in a premier consulting organization.
  • Structured training program and peer mentoring system towards competence and personal growth.

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