Key skills
GCPSanityJiraSDLCProject ManagementCommunication
About this role
Work Flexibility: Hybrid
Job Summary:
The Software Testing & Computer System Validation (CSV) Engineer is responsible for manual testing of software products and tools required at developmental and verification stages along with ensuring computerized systems used in regulated environments (e.g., GMP, GCP, GLP) are validated in compliance with applicable regulatory requirements such as 21 CFR Part 11, Annex 11, GAMP 5.
What you will do
- Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira).
- Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups
- Develop and execute validation strategies and plans for new and existing computerized systems.
- Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceability Matrix.
- Perform impact assessments and change control activities for validated systems.
- Provide training and guidance on CSV processes and best practices.
- Maintain validation documentation in alignment with company procedures and regulatory expectation
What you will need:
Required:
- Experience- 1yrs to 3 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices).
- Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field.
- Good understanding of SDLC, and defect life cycle; Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.
Preferred :
- Understanding of software development life cycle (SDLC) and risk-based validation approaches; CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification
- Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations.
- Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
- Excellent documentation, reporting, communication, and project management skills.