Digital & Automation Support - Vaccine Manufacturing (DS&DP)
6 hours ago
Job Title: Digital & Automation Support (DAS) - VDSP, Lalru & VDPP, Baddi
Reports to: Dotted Line – COO, Vaccine
: Direct – CIO
Department: COO – Vaccine
Location: Baddi, Himachal Pradesh & Lalru, Punjab
Role Summary:
The Digital & Automation Support (DAS) professional will coordinate with IT, QA and Engineering and support the implementation and integration of advanced digital technologies and automation systems to drive operational excellence across the vaccine manufacturing value chain — from Drug Substance (DS) plant to Drug Product (DP) Plant — in alignment with global regulatory and WHO-GMP standards.
Key Responsibilities:
Digitization & Smart Manufacturing:
Coordinate with cross-functional teams (IT, Engineering, QA) to identify and implement digital technologies such as AI, IoT, machine learning, and predictive analytics to optimize manufacturing operations and reduce manual interventions.
Automation Integration:
Evaluate and support implementation of advanced automation platforms including SCADA, DCS, MES (e.g., eBMR/eBR), and real-time monitoring tools to enhance batch traceability, compliance, and turnaround time.
Tech Pilot Evaluation & Scale-up:
Lead pilot trials for digital and automation solutions on the shop floor. Assess feasibility, scalability, and compliance impact before full-scale deployment.
Data Integration:
Facilitate secure, GMP-compliant data exchange and integration between shop-floor systems (PLC/SCADA, LIMS, MES) and enterprise/business systems (SAP, ERP) to ensure seamless information flow and decision-making.
Compliance & Data Integrity:
Ensure all digital systems meet requirements for
21 CFR Part 11
,
Annex 11
, and
GAMP 5
. Support CSV (Computer System Validation) and audit readiness related to automation systems.
Training & Change Management:
Train plant personnel on new systems and technologies. Promote a culture of digital adoption and continuous improvement aligned with global vaccine manufacturing best practices.
Qualifications & Experience:
- Bachelor's/Master's in Engineering (Electronics, Instrumentation, Computer Science) or related field.
- 5–10 years of experience in pharma/biotech manufacturing digital systems, preferably in vaccine production (DS and DP).
- Working knowledge of
eBMR
,
SCADA
,
LIMS, Oracle net suite, eQMS, DMS,LMS,
IoT
,
AI/ML applications
, and
GMP-compliant IT/OT integration
.
Key Skills & Competencies:
- Knowledge of AI, IoT, ML in Vaccine manufacturing
- Experience with SCADA, DCS, MES, eBMR/eBR
- Ability to lead and evaluate digital pilot projects
- Expertise in IT-OT integration (PLC, MES, LIMS, SAP,
Oracle net suite, eQMS, DMS,LMS
) - Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5
- Skills in cross-functional coordination and execution
- Capability to train and drive digital adoption
- Lean/Six Sigma mindset for innovation and efficiency
-
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