Experience: 2 - 4 years in pharma industry
Location: Bengaluru
We are seeking a detail-oriented and technically adept Industrial
Automation Engineer to join our team. The ideal candidate will have
24 years of hands-on experience in Computer System Validation (CSV) of distributed control systems such as
DeltaV, Centum, and PCS7 DCS, as well as expertise in multibrand PLC systems. The role involves ensuring that automated systems meet regulatory requirements
(GAMP 5, 21 CFR Part 11, Annex 11, cGMP) while supporting engineering projects across manufacturing and quality systems.
Key Responsibilities
- Execute Computer System Validation (CSV) activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for DCS and PLC-based systems.
- Validate systems such as DeltaV, Centum, PCS7, ABB, Siemens, Allen Bradley, etc. across various production lines.
- Develop, review, and execute validation protocols, reports, traceability matrices, and risk assessments.
- Support user requirements specification (URS), functional specifications, and design documents ensuring alignment with regulatory guidelines.
- Perform risk-based validation using methodologies such as FMEA, HACCP, or similar approaches.
- Collaborate with cross-functional teams including QA, production, engineering, and IT to ensure seamless integration and compliance.
- Assist in troubleshooting and resolving validation-related technical issues.
- Ensure data integrity and compliance with audit requirements.
- Participate in internal and external audits, inspections, and validation readiness reviews.
- Provide technical support during system lifecycle activities including upgrades, maintenance, and change management.
Qualifications Required:
- Bachelor's degree in Electrical, Instrumentation, Automation, or related engineering discipline.
- 24 years of experience in automation systems and CSV in regulated industries (pharmaceuticals preferred).
- Hands-on experience with DeltaV, Centum, PCS7 DCS systems and multibrand PLCs (Siemens, Allen Bradley, Schneider, etc.).
- Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, cGMP, and data integrity principles.
- Experience in preparing validation deliverables including IQ, OQ, PQ, URS, FRS, trace matrices, and risk assessments.
- Ability to interpret engineering drawings, control logic, and process documentation.
- Excellent communication and documentation skills.
- Detail-oriented with strong analytical and problem-solving abilities
- Ability to work independently and as part of a team.
Preferred:
- Experience with SCADA systems, historian interfaces, and network configurations.
- Exposure to computerized maintenance systems, MES, or ERP integrations.
- Familiarity with regulatory inspection readiness.
