Engineering and Maintenance- Executive/Senior Executive

3 weeks ago


bangalore, India Biocon Biologics Full time
About the Company
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.
Education : B. Tech (Instrumentation, Automation, Mechanical)
Key Skills: PLC, SCADA, HVAC, Automation Background
Experience : 3-7 Years
Primary Responsibilities
Understand 21 CFR Part 11, cGAMP, and other regulatory guidance associated with computer / automation-based systems.
System administration as described above.
Generate user requirement specifications for control systems.
Define requirements for vendor design documentation. Review vendor automation design documentation (FDS, IQ and OQ requirements traceability matrix, code and logic, etc.).
Provide support for Production team w.r.t engineering and design of automated systems
Review qualification protocols of automated systems.
Support the execution of the qualification of automated control systems.
Responsible to maintain the system under validated state by performing the CSV (initial & periodic)
Hands-on and understand and read complex ladder logic, SFC , Function block diagram and Microprocessor based system.
Hands-on and understand PLC, DCS based controllers and functionality.
Troubleshoot on low voltage control wiring and VFDs.
To prepare risk assessments for automated systems along with generating the necessary qualification documents.
Prepare Change Controls associated with changes to control systems.
Able to perform complex assessments for computer systems against current industry compliance requirements
Responsible to Prepare, Review, Perform, monitor and signing of executed checklist of PM activities of Equipment’s and ensuring timely closure of the issue with adequate measures.
Responsible for providing necessary training to employees and get trained himself and ensuring GEP and to comply with audit compliance, safety and Productivity.
Responsible to attend breakdown notifications raised through SAP/ Manual system within the timelines & provide the action plan/solutions to avoid the reoccurrences.
To prepare/ensure document for user management and backups are maintained proper.
Knowledge on process equipment like Autoclave, Centrifuge, Chromatography , Bioreactor and other laboratories instruments.

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