- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …techniques, bioreactor operations, and cell line development + Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing + ... Experience with a variety of expression systems (eg, CHO, HEK293, microbial) + Familiarity with Quality by Design (QbD) principles and their application to upstream processes + Excellent leadership skills with the ability to mentor and develop team members +… more
- Biomat USA, Inc. (Hammond, IN)
- …understanding of project requirements to ensure projects are in compliance with cGMP design, applicable codes, and environmental laws, rules, and regulations. **Job ... Responsibilities:** + Manage facility project design and construction by coordinating, reviewing, and administering the work of Architects, Engineers, Consultants, and Contractors. + Create cost management solutions for facility projects. Manage vendors,… more
- Jacobs (Indianapolis, IN)
- …of Instrumentation and Control System experience desired; experience with industrial/ cGMP manufacturing projects is preferred * Experience using or familiarity ... with current design software (such as AutoCAD, SmartPlant, Revit, VISIO, Bluebeam, and others) required * Must have experience in leading the design on a variety of projects of different sizes * Life Sciences industry experience is highly preferred * Must have… more
- Novo Nordisk (Bloomington, IN)
- …to use Excel, Word, and other office systems + Strong understanding of cGMP regulations, FDA guidelines, and industry standards related to clean utilities, sterile ... manufacturing, inspection and packaging + Flexibility to adapt to changing priorities and deadlines in a fast-paced manufacturing environment + Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver… more
- Jacobs (Indianapolis, IN)
- …* At least 15-years of electrical experience desired; experience with industrial/ cGMP manufacturing projects is preferred * Life Sciences industry experience is ... highly preferred * Experience using or familiarity with current design software (such as AutoCAD, SmartPlant, Revit, VISIO, Bluebeam; others) required * Must have experience in leading the design on a variety of projects of different sizes * Must have the… more
- Novo Nordisk (Bloomington, IN)
- …what matters. The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, ... calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards. Process Engineering focuses on developing processes to minimize risks to the product. The role works with industry… more
- ThermoFisher Scientific (Indianapolis, IN)
- …the daily activities of 1-10 employees + Apply Current Good Manufacturing Practices ( cGMP ) in all areas of responsibility + Remain informed of business deliverables ... and priorities while effectively communicating strategically bi-directionally via tier meetings and leader boards + Work to collaboratively define equipment uptime deliverables, and report out on metrics + Define, implement, and deliver equipment analytics… more
- Lilly (Indianapolis, IN)
- …and information technology, coupled with proven experience supporting cGMP electronic systems within pharmaceutical manufacturing, particularly those related ... to APIs. **Responsibilities:** The Electronic Laboratory Systems Advisor/Sr. Advisor oversees the implementation, validation, and lifecycle management of electronic laboratory systems (such as LIMS and MES) at new Eli Lilly API Manufacturing sites. This… more
- Novo Nordisk (Bloomington, IN)
- …what matters. The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, ... calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards. Process Engineering focuses on developing processes to minimize risks to the product. The role works with industry… more
- Lilly (Indianapolis, IN)
- …in engineering or related technical field. + 5-15+ years' experience in cGMP manufacturing or manufacturing support + **Extensive knowledge of parenteral equipment** ... (5+ years) and operations including automated, semi-automated and/or manual inspection equipment. **Additional Skills/Preferences:** + Familiarity with technology advances in vial, cartridge, and syringe container closure systems. + Strong interpersonal and… more