Posted 16 May, 2026
CSV Specialist
NR Consulting
Hyderabad,Telangana
Full Time
Reference: 365_463738_26-04990
Title: CSV Specialist
Location: Hyderabad
Exp: 8+ years
Job Description:
• 5+ years of experience in Computer System Validation (CSV).
• Experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments.
• Hands-on experience with MES validation and GxP validation lifecycle.
• Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations.
• Experience in validation document preparation, review, execution, and approval workflows.
• Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams.
• Strong documentation discipline and attention to detail.
Preferred MES Experience
• Werum Client-X
• Rockwell PharmaSuite
• Siemens Opcenter Execution Pharma
• Emerson Syncade
• MasterControl Manufacturing Excellence
• Any other pharma MES platform
Pharma Domain Knowledge
• Batch manufacturing process and electronic batch records (eBR).
• Weighing and dispensing, equipment workflows, and material movement.
• Recipe management, line clearance, manufacturing execution, and review by exception.
• QA review, batch release process, audit trail review, and data integrity controls.
Key Deliverables
• Validation Plan and Validation Risk Assessment.
• Requirement Traceability Matrix.
• IQ, OQ, and PQ protocols.
• Executed test scripts with objective evidence.
• Deviation, defect, and issue logs with closure evidence.
• Validation Summary Report.
• Approved validation package supporting MES go-live readiness.
Soft Skills and Working Style
• Strong communication and stakeholder management skills.
• Ability to work independently with clear ownership of assigned validation deliverables.
• Practical understanding of project timelines, validation pressure, and quality gates.
• Comfortable working with business users, QA reviewers, IT teams, and system vendors.
• Accountable, detail-oriented, and focused on inspection-ready delivery.
Location: Hyderabad
Exp: 8+ years
Job Description:
• 5+ years of experience in Computer System Validation (CSV).
• Experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments.
• Hands-on experience with MES validation and GxP validation lifecycle.
• Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations.
• Experience in validation document preparation, review, execution, and approval workflows.
• Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams.
• Strong documentation discipline and attention to detail.
Preferred MES Experience
• Werum Client-X
• Rockwell PharmaSuite
• Siemens Opcenter Execution Pharma
• Emerson Syncade
• MasterControl Manufacturing Excellence
• Any other pharma MES platform
Pharma Domain Knowledge
• Batch manufacturing process and electronic batch records (eBR).
• Weighing and dispensing, equipment workflows, and material movement.
• Recipe management, line clearance, manufacturing execution, and review by exception.
• QA review, batch release process, audit trail review, and data integrity controls.
Key Deliverables
• Validation Plan and Validation Risk Assessment.
• Requirement Traceability Matrix.
• IQ, OQ, and PQ protocols.
• Executed test scripts with objective evidence.
• Deviation, defect, and issue logs with closure evidence.
• Validation Summary Report.
• Approved validation package supporting MES go-live readiness.
Soft Skills and Working Style
• Strong communication and stakeholder management skills.
• Ability to work independently with clear ownership of assigned validation deliverables.
• Practical understanding of project timelines, validation pressure, and quality gates.
• Comfortable working with business users, QA reviewers, IT teams, and system vendors.
• Accountable, detail-oriented, and focused on inspection-ready delivery.
