- Novo Nordisk (Bloomington, IN)
- …and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...other validation technical disciplines, such as equipment validation , computer system validation , and… more
- Cardinal Health (Indianapolis, IN)
- …Bachelor's degree in Engineering or a Physical Science. + 5+ years of relevant validation experience preferred. + Knowledgeable in FDA or ICH qualification. + ... experience and skills and an evaluation of internal pay equity. The Principal Validation Engineer is responsible for supporting the validation program for… more
- Insight Global (Indianapolis, IN)
- …This engineer will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for a pharmaceutical customer. ... have experience managing an environment with human safeties involved. It could be a computer system validation process or a validation equipment process,… more
- Novo Nordisk (Bloomington, IN)
- …verification + Accountable for completion of qPCR/PCR method development, qualification, validation , and execution + Accountable for daily operations of the site's ... for routine testing + Supports instrument onboarding and maintenance + Method Validation + Accountable for daily operations to maintain Quality standards and project… more
- Novo Nordisk (Bloomington, IN)
- …internal and external requirements, including Standard Operating Procedures (SOPs), process validation protocols, and technical reports. + Work closely with Quality ... requirements. + Collaborate effectively with the facility commissioning and validation team to establish operational protocols that ensure compliance with… more
- Novo Nordisk (Bloomington, IN)
- …Functions + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Draft SOPs for building and...future capital projects + Apply and enhance existing automation validation programs for the validation of new… more
- Novo Nordisk (Bloomington, IN)
- …equipment + Proactively and effectively partner with the facility commissioning/ validation team, including operational protocol development, to implement compliance ... with FDA GMP requirements + Draft SOPs for building automation...sub-networks, software, etc.) + Apply and enhance existing automation validation programs for the validation of new… more
- Novo Nordisk (Bloomington, IN)
- …team + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities + Manage ... integration and CSV (Automation Only) + Apply and enhance existing automation validation methods and templates for the qualification of new and existing production… more
- Lilly (Indianapolis, IN)
- …+ Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) and ... direction and standards. + Experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance. + Experience… more
- Lilly (Indianapolis, IN)
- …quality and compliance standards. Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations will be vital in ensuring ... dynamic environment and manage multiple tasks simultaneously. + Experience with Computer System Validation . + Familiarity with serialization protocols, unique… more
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