- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... systems through to operational readiness, as well as provide oversight of validation program execution for these systems. You will collaborate within the Digital… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... processes, through operational readiness, as well as provide oversight of validation program execution for these processes. This role will also collaborate… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... the validation of new functionality releases Develops and maintains process configurations in System based on end user procedures and requirements Collaborates… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... manufacturing. Provide technical knowledge to assess testing approach, verification and validation needs both internally and at external contract labs. Performs QC… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... manufacturing support activities; process monitoring and controlPerform in- process testing (pH, conductivity, visual inspection)Execute validation protocols… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... Standard operating procedures (SOPs) and cGMP regulations.Oversee and/or perform in- process testing (pH, conductivity, visual inspection)Execute validation … more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... manufacturing support activities: Process monitoring and controlPerform in- process testing (pH, conductivity, visual inspection)Execute validation protocols… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... activities as well as process monitoring and control Perform in- process testing (pH, conductivity, visual inspection)Execute validation protocols according… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... manufacturing processing steps and/or manufacturing support activities as well as process monitoring and controlPerform operations of the Drug product filling… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …In addition to drug substance manufacture, it will also provide automated fill - finish and assembly, packaging, and labeling services. The new state-of-the-art ... lab activities and team as neededLeads method verification, qualification, and validation activities and maintain lab equipmentAuthors, reviews, and approves SOPs,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …of relevant experience Experience in biopharmaceutical/combination product development, manufacturing, and/or fill finish validation is preferred. \#LI-MB1 ... Drug Product Engineering department. This role is responsible for process controls and process validation for labeled drug product (LDP) manufacturing… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross ... might include the following: * Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact *… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …level maintenance on equipment + Participates in equipment start-up, commissioning, and validation activities + Works to optimize, trend, and report manufacturing ... process operational parameters during routine manufacturing campaigns + Creates process evaluation reports, process transfer documentation, and process … more
- PCI Pharma Services (Bedford, NH)
- …informed and providing guidance to other engineers as needed. * Write process validation and process simulation media fill protocols and technical study ... of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process ...US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP fill finish … more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation Fill Finish team is hiring an Associate Manager! As the Associate Manager QA Validation you will validate/qualify equipment, systems, ... and processes related to cleaning, sterilization and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and… more
- United Therapeutics (Silver Spring, MD)
- … process and cleaning qualification for processes that may include Solid Dose, API, Fill Finish , and packaging + Utilize skill as an experienced validation ... diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently in… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Validation department at Regeneron is adding to their team! The **Manager for QA Validation within our Fill Finish area** would lead the department that ... is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Rensselaer facility. This… more
- VTI Life Sciences (Los Angeles, CA)
- …looking for an experienced Validation Engineer to support the Aseptic Fill / Finish line qualification project at our client's pharmaceutical facility in the ... Greater Los Angeles area. We need a seasoned validation engineer who is a self-motivated, self-starter who can...client's guidelines. This individual needs to be able to process instructions and work independently on multiple projects in… more
- J&J Family of Companies (Malvern, PA)
- …will be responsible for process development and technology transfer of fill / finish manufacturing processes of biotherapeutic products. They will also work ... all regulatory requirements and expectations. **Primary responsibilities:** * Lead late-stage process development, technology transfer, process validation ,… more
- Amgen (Thousand Oaks, CA)
- …projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas. **DP ... products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous … more
