One Stop Management Services Private Limited – API Engineer (Technical Engineer (Active Pharmaceutical Ingredient, API))

We are looking for an API Engineer who is experience with Electronic Batch Record and corresponding interfaces (like DeltaV)

Major Responsibilities:

• Responsible for setting up / establishing the Electronic Batch Records
• Responsible for manufacturing process technical support and improvement initiatives for ongoing operations
• Support start-up and assist in plant equipment and facility validation and qualification activities
• Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site
• Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s
• Contact and consultant for process/equipment troubleshooting and investigation activities
• Supports risk assessment activities providing relevant technical knowledge
• Provides support for process cleaning/changeover strategies
• Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation

Education/Experience

• Chemical Engineering with >5 years of experience (preferably), in the area of API Manufacturing (Technical Engineer) or Manufacturing, Science and Technology (MSAT) role
• Responsible for manufacturing support of commercial API processes
• Provides rapid response to operational issues and supports ongoing operations including new product introduction, process engineer, process flow diagrams and process batch record authoring