Automation and Validation Specialist
17 hours ago
We are seeking a skilled Automation and Validation Specialist to join our team at Biocon.
In this role, you will be responsible for ensuring the validation of Manufacturing Execution Systems (MES) such as PASX and integration with 3rd Party /L2 (such as DCS)/L3 Systems. You will also define approaches for validation and implementation of pharma 4.0 applications like Validation Lifecycle Management System (Valgenesis), ARVR, DCS, RPA, Dashboards, etc.
The ideal candidate should have expertise in ensuring IT and Security relevant compliance as part of system validation. You should be well-versed in handling QMS & Defects with respect to system validation and its timely closure. Familiarity with GxP Regulations, GAMP5, 21 CFR Part 11, EU Annexure 11 and IT compliance is a must.
You will be responsible for managing the system lifecycle management with respect to validation and documentation (Patch Update, Hotfixs, Trouble shooting, version upgrade, etc.). Additionally, you will coordinate with quality teams and vendors to finalize the approach and expediting project related deliverables timely and smoothly.
This role requires expertise in qualification of HMI, SCADA, L2 Layers and its integrations. You should be able to drive validation of Manufacturing Automation & Digitization process related digital initiatives / transformation. A good process knowledge (API/Injectable/Formulation) is required to understand and map the respective test cases for validating the systems fitting to the business process.
You will develop procedures related to applications, documentation & training to end users. Excellent written, verbal communication skill & Soft skills in MS office-word, excel and ppt are necessary. You should also be responsible to follow HSE, cGMP and other relevant regulations of Pharma/Biotech.
Key Responsibilities:
• Ensure validation of MES such as PASX and integration with 3rd Party /L2 (such as DCS)/L3 Systems
• Define approaches for validation and implementation of pharma 4.0 applications like Valgenesis, ARVR, DCS, RPA, Dashboards, etc.
• Manage system lifecycle management with respect to validation and documentation
• Coordinate with quality teams and vendors to finalize the approach and expediting project related deliverables timely and smoothly
• Develop procedures related to applications, documentation & training to end users
Requirements:
• Expertise in ensuring IT and Security relevant compliance as part of system validation
• Well-versed in handling QMS & Defects with respect to system validation and its timely closure
• Familiarity with GxP Regulations, GAMP5, 21 CFR Part 11, EU Annexure 11 and IT compliance
• Good process knowledge (API/Injectable/Formulation)
• Excellent written, verbal communication skill & Soft skills in MS office-word, excel and ppt
• Ability to follow HSE, cGMP and other relevant regulations of Pharma/Biotech
Estimated Salary: $120,000 - $150,000 per annum
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