- Lilly (Indianapolis, IN)
- …technical related field + 15+ years of related pharmaceutical manufacturing experience/ cGMP working environment + 10+ years experience in parenteral manufacturing, ... specifically technical services-related roles + Prior experience in technical leadership roles Additional Preferences: + Ability to prioritize efforts + Effective written and oral communication skills + Effective interpersonal skills + Ability to maintain a… more
- Cardinal Health (Indianapolis, IN)
- …experience, preferred + Preferable to have experience in pharmaceutical industry and/or cGMP environment. + Willing to obtain DOT (Department of Transportation) and ... IATA (International Air Transport Association) certification within 3 months of hire. + Forklift experience preferred. + Proficient in Microsoft Word and Microsoft Excel and possess strong communication skills. **_What is expected of you and others at this… more
- Kelly Services (Bloomington, IN)
- …weight verification, and maintaining compliance with current Good Manufacturing Practices ( cGMP ). * Performing routine cleanup, line clearances, and sanitizations to ... ensure a safe and organized work environment. **This job might be an outstanding fit if you:** * Have a high school diploma or equivalent and experience in a manufacturing or pharmaceutical environment is preferred. * Are able to work scheduled weekend… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the intended performance and ensure they meet regulatory requirements. + Knowledge of cGMP , GXP, GAMP, SDLC regulations, including 21CFR part 11, EudraLex Annex 11 ... and good documentation practices. + Demonstrated success working in a high-performing, business results-driven environment. **Physical Requirements:** + Standard office environment coupled with GMP production and facility environment. + Must be willing to wear… more
- Cardinal Health (Indianapolis, IN)
- …(Pharmaceutical or Medical Device) preferred + Possess an understanding of cGMP /compliance requirements for cosmetic and pharmaceutical products preferred + Working ... knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred + Working knowledge of Adobe editing software strongly preferred + Working knowledge of Document Management software (Trackwise and/or Smartsolve) strongly preferred +… more
- Novo Nordisk (Bloomington, IN)
- …and equipment upgrades. + Ensure all automation activities comply with FDA, cGMP , and GAMP standards. + Participate in audits, investigations, and change control ... processes. + Support selection and integration of automated manufacturing equipment. + Partner with commissioning and validation teams to meet FDA GMP compliance. + Draft, revise, and maintain standard operating procedures (SOPs) and controlled documents. +… more
- Lilly (Indianapolis, IN)
- …ideally in device assembly or packaging operations. + Working knowledge of cGMP and Computer System Validation (CSV) frameworks + Ability to interpret process ... requirements and translate them into MES configurations or electronic batch records. + Strong troubleshooting skills, with the ability to investigate system issues, identify root causes, and implement sustainable solutions. + Comfortable working on the shop… more
- Cardinal Health (Indianapolis, IN)
- …clean rooms and isolators. + Record and maintain systems regarding cGMP compliance such as consumable inventory levels, area classification requirements, or ... site environmental monitoring. + Communicate all issues related to safety, quality, and compliance to site leadership. + Perform relevant documentation for maintenance activities, as well as modify and/or create SOPs. + Provide input to the Product Development… more
- Lilly (Lebanon, IN)
- …Operations remain compliant with all applicable regulatory requirements. (eg Safety, Quality/ cGMP , Environmental, Financial, Legal, HR.) + Ensure the Production Flow ... Team and Process Teams meet expectations described in Lillys Manufacturing Standards for Operational Excellence + Ensure that a robust control system exists to manage the business, identify compliance issues and escalate issues appropriately is established and… 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 lead difficult ... discussions with customers and subordinates and drive the conversation to an acceptable resolution + Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise +… more