- 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
- 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 ... Job Description Insight Global is looking for a Validation Engineer to support a large HVAC building...Validation ) or IQ OQ PQs protocols within an FDA regulated environment for their pharmaceutical customer. Pharma experience… more
- Lilly (Indianapolis, IN)
- …customers, company, and quality priorities to support implementation objectives. + Participates in computer system validation (CSV), computer software ... particularly those related to APIs. **Responsibilities:** The Electronic Laboratory Systems Advisor/Sr. Advisor oversees the implementation, validation , and… 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 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
- Novo Nordisk (Bloomington, IN)
- …& technology, validation , and IT teams to ensure our automation systems are robust, reliable, and adaptable as production needs evolve. This position requires ... for exceptional talent to help maintain and improve the systems that keep our manufacturing processes safe, compliant, and...of automated manufacturing equipment. + Partner with commissioning and validation teams to meet FDA GMP compliance.… more
- Lilly (Indianapolis, IN)
- …regulatory inspections (eg, FDA , EMA). + Strong knowledge of GxP regulations, computer system validation (CSV), and quality management systems . ... and written communication skills + Strong interpersonal interaction skills + Experienced with Computer Systems Validation / Strong proficiency with IT … more
- Abbott (Westfield, IN)
- …+ Work with Design and Manufacturing Engineering in the completion of system /software requirements and other verification and validation processes. + Create ... and execute or direct software validation protocols traceable to system /software requirements. +...FDA , GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced… more