- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
- Aequor (Libertyville, IL)
- Project Manager - InfrastructureLibertyville, IL - 50% Onsite12 Months Contract with high Possibilities of extensionExperience and Skills:Must have 5&plus years' ... storage, server, cyber, cloud).Must have GMP and computer systems validation experience in pharmaceutical manufacturing.5&plus years of end-to-end project management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the unitized budget against the needs, conducts rigorous negotiation of terms with validation of rates from service providers. Making sure the payment schedules are ... colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development… more
- Aequor (Devers, TX)
- …Update, create, and approve all necessary UAT test scripts. DCT Verification and Validation : Approve Site Procurement Data Load Files in support of simulated to ... Production data Loads. Cutover Planning and Post Go-Live Support: Lead/ Support cutover planning from Oracle to SAP and post go-live activities. Procurement Data Ownership: Ensure alignment on sourcing strategy, including lead times, pricing, vendor IDs, UPOM,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications ... for new equipmentDevelop control charts and statistical process controls for calibration standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/QA of CDISC, SDTM domain output in accordance with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer will participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous improvement efforts following ... Pass Yield, Scrap, number of repeat CAPAs, CAPA On Time, and Validation on Time.Job ResponsibilitiesChange Management - evaluate the impact to product, processes,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for architecting and coordinating the design, installation, commissioning, startup and validation of all assigned new capital improvement projects. Primary the ... System (BMS) and Environmental Monitoring System (EMS). Relationships Reports to: Manager of Automation Engineering Essential Functions Lead, plan, organize and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …will be commisserate with experience. Relationships Reports to: Automation Manager Essential Functions Responsible for assisting with the design, implementation, ... power systems throughout the facility Assists with troubleshooting, testing, validation , deployment and on-going maintenance of Automation Systems Provides support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …manufacturing equipment in accordance with site Change Control and Validation requirementsPerform investigation of manufacturing eventsPerform process & engineering ... processing techniques preferredKnowledge of pharmaceutical product development, manufacturing processes, validation , cGMP's and FDA regulations for the Pharmaceutical IndustryProficiency… more
