- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... , and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment,… more
- Merck & Co. (Rahway, NJ)
- …equipment and instrumentation in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or ... Skills:Adaptability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data… more
- BioAgilytix (San Diego, CA)
- …with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP ... requirements specification, IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations,… more
- Twist BioScience (South San Francisco, CA)
- …11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ ... DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and... (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS,… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… 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. (Rahway, NJ)
- …Qualification and 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)
- …multi-stage refrigeration systems ).Good oral and written communication skillsProficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- Merck & Co. (Durham, NC)
- …Material(s):N/ARequired Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Merck & Co. (Durham, NC)
- …Material(s):n/aRequired Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- BioAgilytix (Durham, NC)
- …processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement ... for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data integrity. Data Quality… more
- Eisai, Inc (Nutley, NJ)
- …software applications development/support in the pharmaceutical or related industries, and system validation methodologies.Excellent technical skills in SAS ... with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation .Strong organizational skills with ability to effectively… more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Merck & Co. (Durham, NC)
- …supplies and products needed to support manufacturing. - Operates various computer -controlled process support/process equipment ( ie washer, autoclave, vial filler, ... - Completes in-process testing and inspections supporting the vaccine manufacturing, validation , and development processes as required . - Identifies and addresses… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Merck & Co. (North Wales, PA)
- …lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs ... strategic initiative teams Education and Minimum Requirement :BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related… more
- Aequor (Hicksville, OH)
- …experience in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient ... upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels...in basic level arithmetic. Working knowledge of metric system . Ability to lift up to thirty pounds, to… more
- Aequor (Cincinnati, OH)
- …Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data ... and FDA regulations Create and maintain lab record documentation (notebooks and computer based) according to GMPs Demonstrate the philosophy of Right First Time… 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
