Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior Process Engineer
Your tasks and responsibilities
• Develop, maintain, support manufacturing processes for commercial biopharmaceutical drug product-S • Focus on cGMP production for market supply • Maintain CMC manufacturing records and documentation (authoring and reviewing technical reports, protocols, technology transfer documents and CMC sections in regulatory filings, TRDs) • Supporting technology transfer from process development to cGMP manufacturing and site transfers of commercial manufacturing processes as required meeting global demand forecasts • Providing ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing of products
Who you are
• MS/Ph.D. in biochemistry/biology/chemistry/pharmaceuticals/ engineering or related field • Experience in support of start-up, tech transfer, and/or sustaining cGMP commercial drug product manufacturing process operations in biopharmaceuticals • Experience / technical knowledge with drug product manufacturing required (i.e. formulation, aseptic filling, lyophilisation) • Detailed knowledge of Process Validation requirements • Experience in outsourced biologics manufacture • Knowledge of cGMP regulatory guidelines • Fluent in English, any other language is a plus
Reference Code: 0000210690