The BioProcess Engineer will be responsible for the development and scale up of internal manufacturing processes to support the growth and advancement of the companies products as well as supporting development and engineering activities associated with outsourced manufacturing.
This position will work closely with key stakeholders including Development, Quality, Manufacturing and external manufacturers to develop and scale processes, equipment and packaging in support of company's products.
- Lead contributor in late stage process development for transferring new products and processes to manufacturing
- Selection of appropriate components and equipment based on analysis of specifications reliability and regulatory requirements for aseptic manufacturing
- Identify, implement and develop equipment to support scale up of internal manufacturing of intermediates.
- Analyze equipment to establish operating data, conduct experimental test and result analysis.
- Ensure that all activities are completed and documented in accordance with procedures
- Designing and executing equipment and process qualifications and validation studies and implementation of new processes and products.
- Drafting equipment and materials specification, operating SOPs, Work Instruction and provide training for manufacturing team members.
- Ensure quality of process and product as defined in the appropriate equipment operation and material specifications
- Support development of relevant manufacturing metrics, data collection, reporting and process improvements.
- Support the development of regulatory CMC documentation.
- Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections.
- B.S. Degree in biomedical engineering, chemical engineering, or similar related field required.
- A minimum of 5 years in biopharmaceutical manufacturing engineering / development required.
- Knowledge of FDA, GMP and ICH requirements
- Proven experience in improving quality and scaling up / out manufacturing processes and systems to support biopharmaceutical development.
- Experience with process development for Biologics, cell based therapies, and/or Advanced Technology Medicinal Products preferred.
- Strong communication skills with the ability to effectively work cross-functionally and externally as required