Computer System Validation

Greythr; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Greythr in Bengaluru is seeking a validation and commissioning specialist to develop engineering documentation for BMS, EMS, ELVS and automation systems. The role covers FAT/SAT testing, system qualification, and building final reports in a GMP environment.

You will develop SOPs, change controls, deviations, CAPAs, and perform root cause analyses. Collaboration with system integrators and cross-disciplinary leads is essential for timely project delivery.

Qualifications

• Knowledge of ISPE and PDA guidelines and GMP regulations.
• Experience with BMS, EMS, ELVS, and process automation systems.
• Experience in SOPs, Change Control, Deviations, CAPAs.
• Experience in Design Qualification (DQ), FAT, SAT and related protocols.
• Development of traceability matrices and final reports.
• Ability to lead projects and coordinate contractors and junior staff.
• Knowledge of regulatory requirements FDA, ICH, ISO, EU for GMP environments.

Responsibilities

• Develop Engineering documentation such as URS, Design Specifications (FS, HDS, SDS, etc.).
• Develop Deliverables & Documentation for BMS, EMS, ELVS & Automation System.
• Testing, Commissioning (FAT, SAT) and Qualification of the BMS, EMS, ELVS & Process Control systems.
• Validation of PCS, BMS, EMS, ELVS in GMP environments.
• Develop SOPs, Change Control Management, Deviation Handling and CAPAs; Root Cause Analysis & Failure Investigations.
• Develop Traceability Matrices, GAP Analysis and Final Reports.
• Lead projects, coordinate contractors and drive results.
• Collaborate with Systems Integrators, Automation leads, HVAC leads & Process leads.

Skills

Engineering documentation

Testing & Commissioning

Root Cause Analysis

Project coordination

Tools

ISPE guidelines

PDA guidelines

FDA regulations

Job description

• Developing Engineering documentation such as URS, Design Specifications (FS, HDS, and SDS, etc.).
• Developing Deliverables & Documentation for BMS, EMS, ELVS & Automation System.
• Testing, Commissioning (FAT, SAT) and Qualification of the BMS, EMS, ELVS & Process Control system (Generation & Execution of Qualification Protocols).
• Well versed with Control System Validations for Process Control System (PCS), Building Management System (BMS), Environmental Monitoring System (EMS) & Extra Low Voltage System (ELVS).
• Development of SOP’s, Change Control Management, Deviation Handling and CAPAs., Root Cause Analysis & Failure Investigation., Leveraging Assessment etc.
• Development of Traceability Matrices, GAP Analysis and Final Reports.
• Ability to effectively lead projects, coordinate contractors, junior level personnel and drive results.
• Working closely with Systems Integrators, Automation leads, HVAC Leads & Process leads.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.