- 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
- Quality Chemical Laboratories (Wilmington, NC)
- …candidates for qualified analytical data reviewers, LabWare LIMS development/configuration/ validation , Document Control Associates, Computer System ... degree in Chemistry or related science and experience in method development/ validation . Special consideration also given to experienced GMP data reviewers. QCL… 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
- Takeda Pharmaceutical Company Limited (Round Lake, IL)
- …Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation ... to the best of my knowledge. Job Description About the role: The Senior Quality Validation Engineer is in the Validation Quality organization at the Takeda Round… 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
- Inteletech Global, Inc. (Jersey City, NJ)
- …experience). 4-7 years of experience in pharmaceutical or biotech industry. Expertise in Computer System Validation (CSV) . Strong understanding of 21 CFR Part ... Benefits: 401(k) 401(k) matching Bonus based on performance Job Title: Validation Engineer (Contractor) Location: Summit - West, New Jersey Type: Contract Job… more
- Omni Inclusive (Summit, NJ)
- …with the ALCOA+ principles of data integrity, risk-based approaches to validation , Computer Software Assurance (CSA) principles *Understanding the concept ... onsite when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise… 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
- Empower Pharmacy (Houston, TX)
- … of systems, equipment, and processes while managing the full lifecycle of Computer System Validation and cross-functional projects. This role plays a critical ... documents for sterile and non-sterile manufacturing. Manages the lifecycle of Computer System Validation , executes multiple protocols, and analyzes data to… more
- Microsoft (Mountain View, CA)
- …engineering experience OR equivalent experience. 5+ years of experience in Computer Architecture and SoC validation principles, including: Broad understanding ... Engineering team is seeking passionate, driven, and intellectually curious computer /electrical engineers to deliver premium-quality designs once considered impossible.… 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)
- …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
- 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
