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)

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