- Legend Biotech USA, Inc. (Raritan, NJ)
- …and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment, ... technical studies, and any associated documentation in support of computer systems validation , equipment, utilities,...instruments, and equipment used at the site.Develops and evaluates quality processes and system standards to ensure… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Qualification and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary ... investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/ system changes, execute periodic reviews and support Quality … 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
- Twist BioScience (South San Francisco, CA)
- …Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ ... systems (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices,… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... including audit and inspection management and oversight of the Quality management system . This role is responsible...and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical… 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
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... Perform routine and non-routine physical and chemical testing of commercial, validation and stability samples in accordance to written methodology Analyze data… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Merck & Co. (Durham, NC)
- …Material(s):N/ARequired Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, ... empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a night shift position, 12… more
- Merck & Co. (Durham, NC)
- …Material(s):n/aRequired Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, ... an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12… more
- Merck & Co. (Durham, NC)
- … Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance, Systems Troubleshooting {+ 3 more}-Preferred Skills:Job Posting End Date:08/1/2025 *A job ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Aequor (Hicksville, OH)
- …experience in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient ... paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual… more
- Merck & Co. (North Wales, PA)
- …in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical ... - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Lilly (Pleasant Prairie, WI)
- …related field. + 2+ years of relevant work experience in information technology, engineering, computer system validation , quality control support or ... Data Leader and Site Tech@Lilly leadership to implement the computer system validation (CSV) and...instruments and systems . + Ensure that site Computer System Inventory list is maintained and… more
- Lilly (Pleasant Prairie, WI)
- …management expertise to solve problems both locally and across global M&Q. Act as the Computer systems validation quality assurance project lead, working ... of experience in Computer System Quality Assurance/ Computer System Validation...and project management experience + Demonstrated proficiency with GMP computer systems validation including regulations… more
- Novo Nordisk (Clayton, NC)
- …required + Minimum of four (4) years of experience in computer system validation or quality related discipline experience in pharmaceutical environment ... Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of...+ Understanding of system development lifecycle including validation of computer systems , operation… more
