- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Merck & Co. (Rahway, NJ)
- …approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- ... and approve qualification protocols and summary reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- BioAgilytix (Durham, NC)
- …is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including ... for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management,… more
- Merck & Co. (Durham, NC)
- …tools and calibration equipment)-Assist with execution of calibration, automation, validation and additional testing, as requiredDecisions are guided by policies, ... procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves technical and… more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... business; Provide quality and regulatory oversight of the design, development, validation , implementation and ongoing maintenance and use of computerized GxP systems… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The Computer Systems Validation (CSV) Manager supports the successful implementation of ... experience in pharmaceutical cGMP environment. + 5 years of hands-on Computer Systems Validation experience. + 3 years of experience with configuring software… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- Catalent Pharma Solutions (Harmans, MD)
- **Job Title:** Manager , Computer Systems Validation **City:** Harmans **State** : MD **JOB DESCRIPTION** : + Serve as the QA-CSV liaison with the ... Engineering, Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to… more
- Wells Fargo (Charlotte, NC)
- …**Model Risk Management (MRM)** organization is seeking a **Quantitative Analytics Manager ** to join its Decision Science and Artificial Intelligence (DSAI) Group ... to support model risk management for **Credit Scoring Model Validation ** . The responsibilities of the DSAI Group include...and performance monitoring, etc. In this specific position, the manager shall focus on models built in house and… more
- Astrix Technology (Atlanta, GA)
- ** Validation Manager ** **_Duties:_** Supervise technical teams and interface with clients to understand their needs regarding Chemistry Testing, developing ... estimates for proposals. Lead Validation Projects and manage the validation lifecycle of computer systems, including planning, executing, and documenting… more
- TD Bank (Mount Laurel, NJ)
- …this role. **Line of Business:** Risk Management **Job Description:** The Senior Manager , Quantitative Analytics oversees and lead a team of Quantitative Strategist ... to the team and others as needed. The Senior Manager , Quantitative Analytics also leads the advanced quantitative models'...strategy and decisions. **This role is to lead the validation of Pre-Provision Net Revenue (PPNR) models used in… more
- BeOne Medicines (San Carlos, CA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager , Systems Validation in San Carlos, CA: **Job Duties:** Manage the entire GxP change control process ... VerifyPlatform, DocuSign, Medidata and Oracle CTMS; (5) Authoring and testing computer system validation deliverables in accordance with 21 CFR Part 11, 210 &… more
- Takeda Pharmaceuticals (Boston, MA)
- …following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Manager , Data Validation Engineer **POSITION DESCRIPTION** : Takeda ... Development Center Americas, Inc. is seeking an Associate Manager , Data Validation Engineer with the following duties: provide strategic planning, integrating,… more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer ... functional areas across the organization to maintain and improve computer system validation processes to ensure robust,...date trainings + Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's… more
- PCI Pharma Services (Rockford, IL)
- …configuration, and fundamentals of heating, air conditioning, and refrigeration systems. ** Computer Validation Focus:** _Associate's Degree in a related field ... calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigate validation deviations, document… more
- System One (Bellevue, WA)
- …Design Basis Accident (DBA) Without Radionuclide Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety ... (EM) following the guidance in NRC's RG1.203. * Perform and coordinate safety computer code verification and validation test programs, including SETs and IETs… more
- Novo Nordisk (Bloomington, IN)
- … strategy and mentor engineers/senior engineers on execution. Relationships Reports to Manager , Validation . Essential Functions + Equipment Validation + ... relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer ...other validation technical disciplines, such as cleaning, computer system validation , and process validation… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …formulation. The **Senior Validation Specialist** with guidance from the Validation Manager , defines and implements procedures and processes to assure ... 5+ years of experience in Equipment/Facilities/Utilities Qualification experience. + 2+ Computer System Validation (CSV) experience in the pharmaceutical… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …and computer system validations. You will report to the Quality Validation Manager . How you will contribute: + **Quality Systems/Document Control:** Owns ... Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation … more
