- 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
- Insight Global (Indianapolis, IN)
- …Qualification, Validation ) or IQ OQ PQs protocols within an FDA regulated environment for their pharmaceutical customer. Pharma experience is not required ... have experience managing an environment with human safeties involved. It could be a computer system validation process or a validation equipment process,… more
- Lilly (Indianapolis, IN)
- …company, and quality priorities to support implementation objectives. + Participates in computer system validation (CSV), computer software assurance (CSA), ... This role will provide quality assurance expertise in the implementation, validation , ongoing maintenance, and lifecycle management of electronic laboratory and… 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)
- …selection and integration of automated manufacturing equipment. + Partner with commissioning and validation teams to meet FDA GMP compliance. + Draft, revise, ... will work closely with process engineering, operations, manufacturing science & technology, validation , and IT teams to ensure our automation systems are robust,… 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)
- …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 operation,...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
- Abbott (Westfield, IN)
- …of FDA , GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and ... conduct training of company personnel for the divisional software development and validation program. + Work with Design and Manufacturing Engineering in the… more
- Lilly (Indianapolis, IN)
- …(eg, FDA , EMA). + Strong knowledge of GxP regulations, computer system validation (CSV), and quality management systems. **Additional Preferences:** ... communication skills + Strong interpersonal interaction skills + Experienced with Computer Systems Validation / Strong proficiency with IT systems development… more