- Regeneron Pharmaceuticals (Troy, NY)
- The Principal GMP Data Integrity Policy Specialist is essential in ensuring that Regeneron's Data Governance systems and practices adhere to the ... policies, and procedures aligned with regulatory requirements and industry standards. As a Principal GMP Data Integrity Policy Specialist, a typical day… more
- Lilly (Lebanon, IN)
- …work from Indianapolis will be required throughout 2025 and 2026.** **Position Summary:** The Data Integrity Sr. Principal Associate oversees data ... processes and facility to enable a successful startup into GMP manufacturing operations. **Note: Final location for this role... data management standards and foster a strong data integrity culture at the site. **Responsibilities… more
- Lilly (Lebanon, IN)
- …technical background to deploy product control strategies, operational control strategies, and data integrity across this new MES platform. The primary focus ... within Operations, Validation, Engineering, Technical Services/MSAT, Quality Assurance, etc.) + Data Integrity - Partner to develop robust and innovative… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …efficiency of our IT infrastructure while strictly adhering to Good Manufacturing Practice ( GMP ) standards. As a Principal IT Systems Engineer, a typical day ... We are seeking a highly skilled and proactive Principal IT Systems Engineer (SecOps) to join our...knowledge sharing and training. + Ensure rigorous compliance with GMP standards and IAM policies across all relevant processes… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Principal Scientist, QC Assay Automation, Cell Therapy** is the subject matter expert leading ... qPCR, flow cytometry). Lead site implementation of automation systems into the GMP QC laboratory. + Work with internal automation development team and external… more
- Cardinal Health (Indianapolis, IN)
- …Solutions are innovative and consistent with organizational objectives. + Maintains data integrity through strict adherence to standardized procedures and ... experience and skills and an evaluation of internal pay equity. The Principal Validation Engineer is responsible for supporting the validation program for Cardinal… more
- Cardinal Health (Juneau, AK)
- …are properly reviewed for quality and documented. **_Job Summary_** The Senior Principal Specialist, executes programs, policies, and procedures within the area of ... quality to minimize risks and drive supply chain integrity . Applying knowledge of quality assurance concepts and technical capabilities, the Senior Principal … more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Principal Scientist is a subject matter expert, project owner and lead ... supporting commercial biologics manufacturing at Bristol-Myers Squibb Devens. The Principal Scientist will oversee and deliver complex technical investigations,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Principal Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer position. The Drug Product (DP) Manufacturing ... support during operations of internal or external manufacturing, reviews process data to ensure operational consistency after processes are successfully transferred… more
- Abbott (St. Paul, MN)
- …people to restore their health and get on with their lives. As a Principal Engineer, you will be providing development support as a part of a multidisciplinary ... practices. + **Communicators** **:** People who can communicate project progress, data analysis and conclusions effectively across a broad set of stakeholder.… more
- Lilly (Indianapolis, IN)
- …over 145 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked ... improving health for people all over the world! The Principal SDD Representative is expected to provide technical leadership...years of experience in support of the development or GMP commercial manufacture of Spray Dried Dispersions (SDD's) as… more
- Lilly (Indianapolis, IN)
- …supporting our mission to deliver life-saving medications to patients worldwide. As a Principal Engineer, you will provide technical oversight and will work to on ... other interventions for potential adverse impact on the safety or quality integrity of the equipment or process. **Innovation and Problem-Solving:** + Provide… more
- Lilly (Lebanon, IN)
- …build the processes and facility to enable a successful startup into GMP manufacturing operations. **Responsibilities:** As an Automation Engineer you will provide ... in measurements, control (process and/or manufacturing), control systems, integration, and data . + Excellent verbal and written communications skills + Ability to… more
- Cardinal Health (Mansfield, MA)
- …testing environment, preferred + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity , Quality Risk Management and other pharmaceutical regulatory ... MA._** **_Responsibilities_** + Provide Quality Assurance review and analysis of data from pharmaceutical stability tests to ensure they meet established quality… more
- Sartorius (Marlborough, MA)
- …for Viral Vectors, mAbs and other biologics. + Analyze and interpret data ensuring clear documentation of methodologies and outcomes. + Prepare detailed reports ... electronic lab notebooks with the highest level of research integrity . + Responsible for writing project reports, briefs, protocols...+ Knowledge of GxPs, experience in process development or GMP operation is a plus. + Demonstrated ability to… more
- Lilly (Indianapolis, IN)
- …comply with internal and external privacy policies and requirements. + Support Data Integrity readiness for regulatory authority inspections and if required, ... of all documentation issued to support the validation/qualification of non- GMP and GMP systems, as appropriate. +...systems. + Recognized understanding of regulations governing CSV and data integrity . **Other Information:** + Role is… more
- Perdue Farms, Inc. (Salisbury, MD)
- …with our people, and our culture is built on a foundation of teamwork, integrity , and respect, where every voice matters and everyone is encouraged to contribute to ... long-term disability protection, flexible spending accounts and paid time off. ** Principal and Essential Duties & Responsibilities** + Lead moderately complex R&D… more
- Perdue Farms, Inc. (Concord, NC)
- …with our people, and our culture is built on a foundation of teamwork, integrity , and respect, where every voice matters and everyone is encouraged to contribute to ... monitors and verifies production SSOP and HACCP records, monitors plant GMP 's (Good Manufacturing Practices) and other prerequisite programs daily, and proactively… more
- AbbVie (Worcester, MA)
- …of technical acumen. Engages with operational staff on the floor in a GMP cleaning room setting to understand what activities are being performed. Leverages ... discussions and working with vendors. It is expected that Principal Engineers are an integral part of the NPI...verbal and written communications. + Designs and leads experiments/gathers data to perform detailed analysis and assess relevance to… more
- Teleflex (Maple Grove, MN)
- …testing, documentation, and manufacturing of new and existing products. ** Principal Responsibilities** * Facilitate and support implementation of Engineering DV ... Process risk documents (DFMEA/PFMEA). * Compile and analyze measurement and testing data results using Excel, Mini-Tab, or other statistical software. * Support… more