- Lilly (IN)
- …selection, contracting, governance, and problem resolution. + Experience and knowledge of cGMP manufacturing environment **Other Information:** + This is a full time ... position **at a new Lilly site in the US** + Flexibility to support sites in multiple time zones is required. + Travel percentage: 5-10%, international travel required. Lilly is dedicated to helping individuals with disabilities to actively engage in the… more
- Kedplasma (Indianapolis, IN)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make your job ... description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if… more
- Lilly (Lebanon, IN)
- …and creating employee development plans + Solid understanding of FDA guidelines and cGMP requirements. + Ability to work 12-hour shifts and overtime as required. + ... Knowledge of lean manufacturing principles + Ability to work with a team, make independent decisions, and influence diverse groups. + Ability to instill teamwork within the shift and demonstrate key interpersonal skills. + Ability to communicate verbally and… more
- Lilly (Indianapolis, IN)
- …vendor management + Excellent verbal and written communications skills + cGMP Regulatory knowledge in process or automation engineering **Additional Information** + ... This position supports Lilly's drug product and drug substance network globally and may require US and OUS travel (up to 15%) as well as off-hour meetings due to time zone differences. + Monday through Friday, Day Shift Lilly is dedicated to helping… more
- Novo Nordisk (Bloomington, IN)
- …work tasks assigned + Executes complex with high quality + Knowledge of cGMP , ICH, FDA, EMA regulations or guidelines + Intermediate understanding of pharmaceutical ... laboratory and/or production operations + Capable of learning unfamiliar principles or techniques with training + Prior experience leading deviation investigations using root cause analysis tools + Champion change control and corrective / preventative actions… more
- Lilly (Indianapolis, IN)
- …experience managing initiatives with aggressive timelines. + Thorough knowledge/experience in cGMP , ICH, USP, and other applicable regulations. + Six Sigma Green ... Belt or Black Belt certification. **Additional Information:** + Significant domestic or international travel may be required (~25%). + Tasks may require entering development or manufacturing areas which require wearing appropriate PPE. Lilly is dedicated to… more
- Lilly (Lebanon, IN)
- …experience administrating Process Automation Systems and Platform preferable under a cGMP regulated environment (demonstrated with work experience and/or training on ... at least 2 platforms: Emerson Delta-V, Rockwell Aset Center, Rockwell Factory Talk, Johnsons Controls Metasys, Aveva Pi). **Additional Skills/Preferences:** + Ability to work in a safe manner to ensure the safety of self and others. + Working experience on… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …filtration, and potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). ... + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work… more
- Novo Nordisk (Bloomington, IN)
- …data integrity and ensure compliance with company SOP's, specifications, as well as cGMP , ICH, FDA, EMA regulations or guidelines + Able to combine and interpret ... data from multiple disciplines and has a commanding understanding of the full Biologics process + Well-organized with ability to handle and direct multiple activities across departments simultaneously + Behavioral Requirements: + Shares own ideas in a… more
- Lilly (Indianapolis, IN)
- …compliance with safety rules and closely following approved procedures for ensuring cGMP compliance. All work performed must be documented by following Good ... Documentation practices. + Work with Supervisor and Senior Operators to ensure scheduled work is executed + Work with Supervisor and Planner Scheduler to redline Job Plans and procedures. + Maintain efficient and effective communications with utilities… more