- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- Merck & Co. (Rahway, NJ)
- …and instrumentation in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded ... Skills:Adaptability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity… more
- BioAgilytix (San Diego, CA)
- …specification, IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, ... with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System Validation , following GxP regulations and GAMP… 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 protocols ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... Travel (approximately 15%)This role is hybrid and requires at least 2 days per week working onsite in our Nutley, NJ office. Eisai Salary Transparency Language:The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 requirements, industry best… more
- Merck & Co. (Rahway, NJ)
- …approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- ... and approve qualification protocols and summary reports.- Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation … more
- BioAgilytix (Durham, NC)
- …for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass ... project deliverables with client timelines and expectations.Lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs, and/or… more
- BioAgilytix (Durham, NC)
- …Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and ... into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA, EMA, or sponsor… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… more
- Eisai, Inc (Nutley, NJ)
- …of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management, ... terms of program development and propose/implement solutions. Requirements Bachelor's degree in computer science or related field required.Must have 10 or more years… more
- Merck & Co. (Rahway, NJ)
- …manufacturing (molding and assembly) is preferred but not required.Proficient in computer -aided design (CAD) and computer -aided engineering (CAE) software such ... Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/ARequired Skills:Analytical Method Development, Computer -Aided Design (CAD), Computer -Aided Design And Drafting… more
- Merck & Co. (Durham, NC)
- …tools and calibration equipment)-Assist with execution of calibration, automation, validation and additional testing, as requiredDecisions are guided by policies, ... multi-stage refrigeration systems).Good oral and written communication skillsProficiency in computer systems and applications including but not limited to:-… more
- Merck & Co. (Durham, NC)
- …and assisting process project engineers.Assists with execution of automation, validation and additional testing, as requiredFollows instructions for completion of ... Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Data Analysis Management, Electrical Engineering, Electrical Maintenance,… more
- Merck & Co. (Durham, NC)
- …and assisting process project engineers.Assists with execution of automation, validation and additional testing, as requiredFollows instructions for completion of ... Skills:cGMP Regulations, cGMP Regulations, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Electrical Maintenance, Equipment Commissioning, Equipment Maintenance, Good… 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)
- …paperwork for upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels for individual ... in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient in basic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical ... instructional design and Train-the-Trainer programsCurriculum and module design experienceAdvanced computer skills and practical knowledge of MS Office Suite,… 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. (Rahway, NJ)
- …for statistical programming deliverables. Contribute to the development and validation of datasets following CDISC standards. Generate tables, listings, and ... project team members.Education RequirementsMust have a master's degree in computer science, Data Science, Statistics, Applied Mathematics, Life Sciences, Engineering… more
