- 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
- 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
- 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
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency 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
- 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)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency 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)
- … 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
- BioAgilytix (San Diego, CA)
- …proficiency with data management, analysis, and statistics, etc.Understands and applies computer validation principles, computer literate with knowledge ... Chemistry departments. This role oversees daily laboratory operations, scientific quality , and regulatory compliance across both functions, supervising up to… 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
- 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
- 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
- Quality Chemical Laboratories (Wilmington, NC)
- …reviewers, LabWare LIMS development/configuration/ validation , Document Control Associates, Computer System Validation and Data Integrity Specialists, ... Quality Chemical Laboratories (QCL), a pharmaceutical testing and...in Chemistry or related science and experience in method development/ validation . Special consideration also given to experienced GMP data… 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
- Katalyst HealthCares and Life Sciences (San Mateo, CA)
- …Strong understanding of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing. Flexibility to work across time ... Responsibilities: Proven leadership in testing/ validation for medium to large system implementations, ensuring GxP compliance and quality delivery. Extensive… more
- Charles River (Wayne, PA)
- …metrology function. Oversee and support the testing phase of equipment monitoring systems validation efforts. Oversee equipment validation efforts regarding ... environment. Experience involving active participation in metrology, equipment qualification and system validation efforts, preferably at the project management… more
- Catapult (Princeton, NJ)
- … activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system , cleaning, and manufacturing processes in an ... hands-on approach and in collaboration with the engineering and Quality teams. Manage multiple validation projects simultaneously,...such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …with regulatory and quality standards. Requirements: 5-8 years of experience in Computer System Validation (CSV). Strong knowledge of FDA regulations and ... Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7… more
