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
