- Mallinckrodt Pharmaceuticals (Hazelwood, MO)
- …Global Technical Operations organization. Responsibilities include analytical method development, validation , and transfer to internal and external GMP laboratories; ... timely execution of project deliverables. Essential Functions + Lead the development, validation , and transfer of analytical methods using techniques such as HPLC,… more
- Amgen (Holly Springs, NC)
- …as the site's Business Process Owner (BPO) for Empower. Reporting directly to the Manager of Quality Control Support, you will serve as a subject matter expert for ... based systems. Your expertise will help drive the startup, validation , and ongoing success of the QC Chemistry team...+ Degree in Scientific Field such as Chemistry or Pharmaceutical Sciences or related scientific field. + 4+ years… more
- Danaher Corporation (Muskegon, MI)
- …The Quality Assurance Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site Validation Master ... Plan. This position reports to the Quality Assurance Manager and is part of the Quality Assurance Department located in Muskegon, MI and will be an on-site role.… more
- Fujifilm (College Station, TX)
- **Position Overview** The Computer System Validation (CSV) Engineering Support Tech will support cross-functional teams by assisting in drafting and executing ... validation protocols for computer systems and process control systems.... activities. . Collaborate with Sr. Engineers and CSV Manager on protocol execution and data analysis. . Review… more
- University of Rochester (Rochester, NY)
- …ClinPro by acting as second QA check of the execution of validation scripts, and manages metrology activities; calibration of in-process packaging equipment and ... + Audit findings are reported to the respective functional manager for responses and corrective actions. + Conduct internal...Write new and update existing SOP's as needed. Author validation protocols as necessary for new and existing equipment.… more
- Sanofi Group (Morristown, NJ)
- …Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute building the Human Target Validation ... of multiple disciplines into a coherent translational medicine and human target validation plan is essential. We are an innovative global healthcare company with… more
- Hovione (East Windsor, NJ)
- …as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people ... and new analytical methodologies - Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as… more
- West Pharmaceutical Services (Exton, PA)
- …and industry standards concerning data integrity, including computer system validation , audit trails, electronic signatures, and data storage and retention. ... industry expectations in terms of data integrity requirements: computer system validation , audit trail, electronic signature, data storage and retention. + Perform… more
- Hovione (East Windsor, NJ)
- …as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people ... life. You will be responsible to: Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP… more
- Amgen (Thousand Oaks, CA)
- …the Drug Product Technologies organization. Working with the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this ... excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. This role will be based… more