Senior Associate

2 weeks ago

Bengaluru, Karnataka, India IncepBio Full time ₹ 8,00,000 - ₹ 24,00,000 per year

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
2–4 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.
  • 2–4 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.

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