Computer System Validation Specialist

We are looking for a skilled Computer System Validation (CSV) Specialist to join our team. In this role, you will focus on assisting our clients in validating quality management system (QMS) software within the life sciences industry. You will ensure that the QMS software solutions meet regulatory requirements and industry standards, supporting our clients in achieving compliance with Good Manufacturing Practices (GMP), FDA, EMA, and other applicable regulations.
This is a client-facing role that requires strong technical expertise, regulatory knowledge, and excellent communication skills.
The core responsibilities for the job include the following:
System Validation Support for Clients:
Lead the validation of QMS software for clients, including planning, execution, and documentation of validation activities.
Develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR).
Guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11 EU Annex 11 and GAMP 5
Risk Management and Data Integrity:
Conduct risk assessments for computerized systems to identify potential gaps in compliance.
Provide recommendations for mitigating risks related to data integrity, security, and system functionality.
Client Training and Documentation:
Trained client teams on validation processes, regulatory requirements, and best practices for maintaining validated systems.
Develop Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance.
Regulatory Expertise:
Stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts.
Guided data integrity principles and ensured alignment with industry standards.
Requirements:
Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field. A Master's degree is a plus.
Minimum of 2 years of experience in computer system validation within the life sciences industry.
Experience with QMS software implementation is highly desirable.
Proven track record of working with regulatory frameworks such as FDA 21 CFR Part 11 EU Annex 1,1 GAMP 5 or ISO 13485
Technical Skills:
Strong understanding of validation methodologies and documentation requirements for computerized systems.
Familiarity with leading QMS software platforms such as ETQ Reliance, MasterControl, Veeva Vault QualityDocs/Quality Suite, TrackWise Digital, or similar tools is a plus.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and project management tools.
Soft Skills:
Excellent written and verbal communication skills to interact effectively with clients at all levels of an organization.
Strong problem-solving skills with the ability to manage multiple projects simultaneously under tight deadlines.

Experience
2-6 yrs