Title:  Executive - Engineering CSV

Position Summary

The Executive – Engineering (Computer System Validation) is responsible for planning, execution, and maintenance of computer system validation (CSV) activities for manufacturing, laboratory, and utility systems in compliance with USFDA, 21 CFR Part 11, EU‑GMP, and GAMP‑5 guidelines. The role ensures data integrity, regulatory compliance, and lifecycle management of computerized systems used in OSD manufacturing operations.

Key Responsibilities

Computer System Validation (CSV)

• Plan and execute CSV lifecycle activities including URS, FRS, HDS, RA, IQ, OQ, PQ, and Validation Summary Reports (VSR).
• Perform validation of manufacturing, packing, QC, and utility systems (PLC/SCADA/DCS, EMS/BMS, LIMS, ERP, QMS, chromatography systems, CSV‑related equipment).
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP‑5, and Data Integrity (ALCOA+) principles.
• Prepare and review validation protocols, SOPs, templates, and reports.

Change Control & Periodic Review

• Manage CSV‑related change controls, deviations, CAPAs, and impact assessments.
• Conduct periodic reviews and re‑qualification of computerized systems.
• Support risk‑based validation approaches for new and existing systems.

Audit & Regulatory Compliance

• Support USFDA, MHRA, WHO, and customer audits related to CSV and data integrity.
• Address audit observations, prepare responses, and ensure timely closure.
• Maintain inspection readiness and validation documentation as per regulatory expectations.

Engineering & Cross‑Functional Support

• Coordinate with Quality Assurance, IT, Production, QC, and vendors for validation activities.
• Provide CSV inputs during new project execution, system upgrades, automation installation, and technology transfers.
• Review vendor documentation such as FAT, SAT, and qualification packages.

Documentation & SOPs

• Draft, revise, and implement CSV and Engineering SOPs.
• Maintain validation status reports and system inventory registers.
• Ensure document control and archival as per GMP requirements.

Qualifications & Experience

Education

• Bachelor’s degree in Engineering (Instrumentation, Electrical, Electronics, Computer, Mechanical, or related discipline)

Experience

• 5–8 years of hands‑on experience in CSV within a USFDA‑approved OSD manufacturing facility
• Strong exposure to manufacturing automation systems and regulated computerized systems

Technical & Regulatory Skills

• Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP‑5, and ICH guidelines
• Understanding of PLC/SCADA/DCS, EMS/BMS, LIMS, and ERP validation
• Hands‑on experience with risk assessment tools (RA, FMEA)
• Strong documentation, analytical, and regulatory communication skills

Behavioral Competencies

• Good coordination and stakeholder management skills
• Detail‑oriented with strong compliance mindset
• Ability to handle audits and regulatory interactions confidently
• Proactive and process‑improvement oriented

Preferred

• Experience in OSD formulation & packing automation validation
• Exposure to Data Integrity remediation projects
• Prior USFDA audit handling experience