Computer System Validation

Incepbio Pvt Ltd; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Incepbio Pvt Ltd in Bengaluru, Karnataka, invites a Validation Engineer to develop engineering documentation such as URS and Design Specifications (FS, HDS, SDS) for GMP environments.

You will lead testing, FAT/SAT, qualification of BMS, EMS, ELVS and Process Control systems; draft SOPs, change controls, CAPAs, deviations, root cause analyses, and final reports while collaborating with system integrators and cross-functional teams to ensure adherence to ISPE, PDA, FDA/ICH/ISO guidelines.

Qualifications

• Developing engineering documentation such as URS, Design Specifications (FS, HDS, SDS).
• Developing deliverables for BMS, EMS, ELVS & automation systems.
• Testing, commissioning (FAT, SAT) and qualification of BMS/EMS/ELVS/Process Control systems.
• Control system validations for PCS, BMS, EMS & ELVS.
• Development of SOPs, change control, deviations, CAPAs, root cause analysis & failure investigation.
• Development of traceability matrices, GAP analysis and final reports.
• Ability to lead projects, coordinate contractors and drive results.
• Working with Systems Integrators, automation leads, HVAC leads & process leads.
• Knowledge of ISPE, PDA and regulations (FDA, ICH, ISO, EU) for GMP environments.

Skills

Engineering Documentation

Validation

GMP Compliance

Tools

URS/DS Tools

QA/QC Tools

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.