- Merck & Co. (Rahway, NJ)
- …Qualification and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary ... Job DescriptionThis Senior Engineer position will provide engineering support to...reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will… more
- Merck & Co. (North Wales, PA)
- …- Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and ... initiative teams - Education and Minimum Requirement : BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the ... organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet strict regulatory… more
- Merck & Co. (Durham, NC)
- …Material(s):N/ARequired Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, ... and patients on time, every time, across the globe. The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… more
- Merck & Co. (Durham, NC)
- …Material(s):n/aRequired Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, ... manufacturer? If so, then this is the opportunity for you! The Senior Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… 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
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- Curia (Rensselaer, NY)
- …responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems Engineer will ... Senior QA Validation Specialist - CSV Systems Engineer...experience working in a cGMP regulated industry specific to computer systems validation + … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated ** Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory ... Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… 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
- NVIDIA (Santa Clara, CA)
- …1999 sparked the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU deep learning ignited ... of technological advancement. As a member of our Mixed Signal Design Validation team, you will lead bring-up activities and characterization of high-speed mixed… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... Senior Principal Validation Engineer in Albuquerque,...validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment… more
- System One (Bellevue, WA)
- …Release * Nuclear safety analysis computer code assessment, verification and validation The Senior Safety Verification and Validation Engineer may ... System One is seeking highly motivated Senior Safety Verification and Validation Engineer...guidance in NRC's RG1.203. * Perform and coordinate safety computer code verification and validation test programs,… more
- Microsoft Corporation (Hillsboro, OR)
- …achieve that mission. The Silicon Computing development team is currently seeking a Senior Systems on Chip Hardware (Digital, Analog or Power and Performance) ... development of custom silicon for a diverse range of systems . Their ultimate goal is to deliver cutting-edge and...complex and high-performance functions. We are looking for a ** Senior SoC HW (Analog/Functional) Validation Engineer** to… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Senior Validation Specialist** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... we offer a broad range of integrated formulation. The ** Senior Validation Specialist** with guidance from the...procedures and processes to assure that Catalent facilities, equipment, computer , and supporting systems are fit for… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …process vessels, clean-in place systems , and parts washers. The ** Senior Cleaning Validation Specialist** also responsible for supporting the design, ... ** Senior Cleaning Validation Specialist** **Position Summary**...department is responsible for ensuring that all facilities, processes, equipment/ systems and automated equipment used for GMP/GLP critical purposes… more
- TD Bank (Mount Laurel, NJ)
- …performance + Represent MRM in regulatory exams and internal audits + Present validation findings to key stakeholders and senior management The candidate should ... role. **Line of Business:** Risk Management **Job Description:** The Senior Manager, Quantitative Analytics oversees and lead a team...strategy and decisions. **This role is to lead the validation of Pre-Provision Net Revenue (PPNR) models used in… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …innovation, to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist, Validation Services, you will play a key role in ... ensuring protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager, Validation Services, you will manage and coordinate installation,… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …innovation, to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist, Validation Services, you will play a key role in ... ensuring protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager, Validation Services, you will manage and coordinate installation,… more
