Company Overview
Role Purpose
Job Purpose
To lead and manage Instrumentation & Automation (I&A) activities for the DS Biosimilar facility, ensuring reliable, compliant, and efficient operation of automation systems supporting manufacturing, utilities, and compliance requirements.
The role will drive automation strategy, system upgrades, regulatory compliance, audit readiness, and lifecycle management of automation platforms.
Academic Stream
B.E
Work experience (in months)
Required Qualifications
- Bachelor’s / master’s degree in Instrumentation /Electronics / Automation Engineering.
- 15–18+ years of relevant experience in Biopharmaceutical / Biosimilar manufacturing.
Job Responsibility and key Decisions
Job Purpose
To lead and manage Instrumentation & Automation (I&A) activities for the DS Biosimilar facility, ensuring reliable, compliant, and efficient operation of automation systems supporting manufacturing, utilities, and compliance requirements.
The role will drive automation strategy, system upgrades, regulatory compliance, audit readiness, and lifecycle management of automation platforms.
Key Responsibilities
1️⃣ Automation System Leadership
- Lead and manage Siemens/Rockwell-based automation systems including:
- Siemens PLC (TIA Portal, SIMATIC Manager)
- PCS7 (including Batch processing as per ISA-88 standards)
- Oversee automation architecture for process and utility systems.
- Ensure high system availability and reliability for manufacturing operations.
2️⃣ Process System Expertise – Downstream & Upstream
Provide technical oversight and support for automation related to:
Upstream Systems
- Bioreactors
- Associated process control and monitoring systems
Downstream Systems
- Centrifuges
- Chromatography systems
- Filtration systems
- Buffer preparation systems
Utility & Support Systems
- Water systems (PW, WFI)
- BMS / EMS
- Clean utilities integration
3️⃣ Regulatory & Compliance
- Ensure compliance with:
- 21 CFR Part 11
- GAMP5
- Data integrity requirements
- Support internal and external audits (USFDA, MHRA, EU GMP, etc.)
- Review and approve validation documentation (URS, FS, DS, FAT, SAT, IQ, OQ)
4️⃣ Instrumentation & Controls
- Strong knowledge of:
- Field instrumentation
- Calibration practices
- Control valves, sensors, transmitters
- VFD systems
- Ensure robust preventive and predictive maintenance strategies.
- Support troubleshooting and root cause investigations.
5️⃣ Project & Upgrade Management
- Lead automation upgradation projects and system lifecycle management.
- Plan migration activities (legacy to upgraded platforms).
- Coordinate with cross-functional teams (Manufacturing, QA, CSV, Projects).
- Drive digitalization and continuous improvement initiatives.
6️⃣ Team & Stakeholder Management
- Lead and mentor automation engineers and technicians.
- Coordinate with OEMs and system integrators.
- Act as SME during regulatory audits.
- Ensure documentation and SOP adherence.
