- Merck & Co. (San Francisco, CA)
- …the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to ... robustness across organizational deliverables.- In this role, the DSCS Digital Project Manager will provide tactical direction and partner with the DSCS Digital… 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 ... vendor setup from one ERP System to another ERP Systems (ie, Oracle to SAP). Dual Sourcing Setup: When...Biopharma or medical device industry Min 4 yrs exp with Procurement UAT, Training others on ERP systems , and… more
- Merck & Co. (Rahway, NJ)
- … Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation ... plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP… more
- Merck & Co. (Durham, NC)
- …perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling ... towers air compressors, waste deactivation systems )Clean Utility Equipment (eg HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse… more
- Merck & Co. (Rahway, NJ)
- …performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating ... facilitation, scribing, and communication. Other duties as assigned by manager for the flexible functioning of the work group....etc.) and ability to adapt to learning other electronic systems to support day-to-day work. - Preferred Experience and… more
- Eisai, Inc (Nutley, NJ)
- …with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively ... and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems . ... as needed as well as the continued operation of such facilities Ensures systems and processes are verified and validated in a compliant manner in accordance… more
- Novo Nordisk Inc. (Durham, NC)
- …practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches etc. for optimization ... pathway) and with little to no guidance from the manager . Responsible for providing data-based insights as business and...development & initiative to understand the site process control systems , data management systems , and differing data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene Therapy… more
- Trane Technologies (Minneapolis, MN)
- …sustainability and excellence in our products and services. Join our team as a **Controls Systems Test Validation Manager ** where you will gain exposure to ... on:_ + Development, execution, and documentation of comprehensive test plans and validation products for control systems ensuring appropriate coverage at all… 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 ... requirements from business stakeholders to establish intended use of computerized systems . Collaborate with project stakeholders to author validation … more
- Amazon (Austin, TX)
- …want to reach beyond what is possible today. Key job responsibilities As a Validation manager , you are responsible for validating the chip and system ... other functional teams to ensure delivery of high quality systems to AWS data centers * Own validation... systems to AWS data centers * Own validation schedules and reporting of progress metrics * Provide… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The Computer Systems Validation (CSV) Manager supports the successful implementation of ... to the completion of milestones associated with equipment qualification and systems validation . With minimum supervision and given general instructions,… more
- Amazon (Redmond, WA)
- …collective pursuit of technical excellence. We are seeking an Senior Interdisciplinary Systems Engineer / Technical Program Manager . This role includes direct ... the state of the art in space and ground-based systems . Successful candidates will have the opportunity to engage...responsibility for Verification & Validation of the Kuiper system. This is a highly… 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 ... IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to Apprentice Tempo Electronic… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. +… more
- Curia (Rensselaer, NY)
- …(5) years' relevant experience working in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP quality control ... Senior QA Validation Specialist - CSV Systems Engineer...date trainings + Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's… more
- Astrix Technology (Atlanta, GA)
- ** Validation Manager ** **_Duties:_** Supervise technical teams and interface with clients to understand their needs regarding Chemistry Testing, developing ... projects, acting as the primary Subject Matter Expert (SME) for systems validation in Chemical Laboratories. Apply expertise in GAMP5 guidelines to develop and… more
- WuXi AppTec (Middletown, DE)
- …seeking a highly experienced and detail-oriented **CQV (Commissioning, Qualification, and Validation ) Manager ** to lead the execution of commissioning ... qualification, and validation activities at...Manager is responsible for ensuring all equipment, computerized systems , facilities, and processes meet regulatory and quality standards… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …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 requirements and support, follow...the following years of experience for each level: + Manager : 7 + years + Sr. Manager :… more
