- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... other validation technical disciplines, such as equipment validation , computer system validation...plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This… more
- Cardinal Health (Indianapolis, IN)
- …systems including manufacturing equipment, laboratory instrumentation, utilities, spreadsheets, and computer systems . + Develop and/or review master level ... guidance to local project teams on a range of validation and qualification initiatives to ensure existing systems...or a Physical Science. + 5+ years of relevant validation experience preferred. + Knowledgeable in FDA … more
- Insight Global (Indianapolis, IN)
- …will have experience managing an environment with human safeties involved. It could be a computer system validation process or a validation equipment ... will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for...to go onsite in Castleton area -Familiarity of HVAC systems null We are a company committed to creating… more
- Novo Nordisk (Bloomington, IN)
- …Draft, review, execute, and approve protocols and reports related to Computerized System Validation (CSV), including the management of deviations during ... team to establish operational protocols that ensure compliance with FDA GMP requirements. + Draft, review, and update SOPs...as the primary Subject Matter Expert (SME) for Computerized System Validation . + Review and approve changes… more
- Novo Nordisk (Bloomington, IN)
- …+ Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution + ... audit observations and corrective actions as it pertains to building automation system validation + Identify and implement improvement opportunities for… more
- Novo Nordisk (Bloomington, IN)
- …+ Draft, review, execute, and approve protocols and reports related to Automation System Validation (CSV). This includes deviation reporting during execution + ... audit observations and corrective actions as it pertains to automation system validation + Identify and implement improvement opportunities for… more
- Novo Nordisk (Bloomington, IN)
- …Draft, review, execute, and approve protocols and summary reports related to Automation System Validation (CSV).. + Review and approve changes to computerized ... + Technical Requirements: + Ability to use Excel, Word, and other office systems + Strong understanding of cGMP regulations, FDA guidelines, and industry… more
- Lilly (Indianapolis, IN)
- …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... the latest technology, advanced highly integrated and automated manufacturing systems , and have a focus on minimizing the impact...direction and standards. + Experience leading or supporting the Computer System Validation of IT… more
- Lilly (Indianapolis, IN)
- …meet quality and compliance standards. Experience with Good Manufacturing Practices (GMP) and Computer System Validation (CSV) regulations will be vital in ... environment and manage multiple tasks simultaneously. + Experience with Computer System Validation . + Familiarity...+ Familiarity with industry standards such as GS1 and FDA DSCSA regulations + System integration with… more
- Novo Nordisk (Bloomington, IN)
- …through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and ... for routine testing + Supports instrument onboarding and maintenance + Method Validation + Accountable for daily operations to maintain Quality standards and project… more