- Daiichi Sankyo, Inc. (Bernards, NJ)
- …performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… more
- Aequor (Thousand Oaks, CA)
- …meet milestones on time. The qualified candidate will support verification, validation , and regulatory submissions of these devices. Work within a cross-functional ... functions.Responsibilities:Lead medium/small projects independently and work directly with Program Manager on large multi-year programs. Managing the overall program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... to ensure compliant practices from all employees participating in the release process .Work in a team based, cross-functional environment to complete tasks required… more
- Aequor (Louisville, KY)
- …onsite. *Shift will be Monday-Friday, 8 AM - 5 PM Feedback from hiring manager intake: Preferred Candidate Qualities - Analytical thinking What stands out on resumes ... Minimum Education - Bachelor's with 4 years of experience C&Q Project Manager ?Responsible for managing the Commissioning and Qualification (C&Q) strategy or main… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Digital Strategy & BI in managing simplification and streamlining of the Source-to-Pay process within Novo Nordisk Inc (NNI). The role is responsible for stakeholder ... stakeholder experience. It collaborates closely with subject matter experts, SOP and process and system owners within NNI and Novo Nordisk A/S respectively to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …operations and practices comply with established procedures and records Assures in- process tests are performed in accordance with standard procedures Provides input ... the operation of the area Support evaluation, specification, installation, and validation of new manufacturing equipment as needed Maintains validated systems and… more
- Merck & Co. (Rahway, NJ)
- …drug linkers in antibody drug conjugates (ADCs), formulated drug products, process , and drug-product intermediates for all new products.- Sponsor the implementation ... 14+ years of relevant experience.Experience in late-stage development, including development, validation and/or transfer of methods for API and intermediates in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …site is a commercial biologics manufacturing facility, prior experience in a bio- process manufacturing environment and/or within the life science industry is a plus. ... with relocation assistance eligible for selected candidate. Relationships Reports to: Manager of cLEAN & Training Number of subordinates with direct/indirect… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... approves validation documentation Reviews and assesses deviations; includes tracking, follow-up...in work priorities We commit to an inclusive recruitment process and equality of opportunity for all our job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development, analysis files development, data surveillance review, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as ... analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports… more
- Danaher Corporation (Fargo, ND)
- …be a part of the Process Validation team and report to the Process Validation Manager responsible for supporting internal and external validation ... and delivery of solutions that safeguard and improve human health. The Process Validation Engineer is part of the Technical Operations Department located in… more
- Danaher Corporation (Fargo, ND)
- …be a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external ... and delivery of solutions that safeguard and improve human health. The Process Validation Engineer II is part of the Technical Operations Department located in… more
- PCI Pharma Services (Bedford, NH)
- …network to pioneer and shape the future of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process Validation Engineer ... teams and performing validation activities such as Performance Qualification (PQ), Process Validation (PV) and Revalidation (RV) in support of cGMP… more
- Bristol Myers Squibb (Indianapolis, IN)
- …global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's ... + Draft and review of Computer System Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ,… more
- PCI Pharma Services (Philadelphia, PA)
- …By: Dennis Gerlach Approved By: Nancy Dorr **Summary of Objective:** Validation Manager - Sterilization, Sterility Assurance, and Utilities/Facilities is ... resources for protocol execution. Collaborates with the site commercial Validation Manager for any validation ...strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation Fill Finish team is hiring a Manager ! As the Manager , QA Validation you will validate/qualify equipment, systems, and processes related ... to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory...the following years of experience for each level: + Manager : 7 + years + Sr. Manager :… more
- Bristol Myers Squibb (Devens, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager , Cleaning Validation , Validation Engineering **Location** : ... the design, implementation and maintenance of a robust cleaning validation lifecycle for process equipment and systems,...of a robust cleaning validation lifecycle for process equipment and systems, that includes a bench-scale cleaning… more
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