- 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
- Twist BioScience (South San Francisco, CA)
- …DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for ... Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols… more
- BioAgilytix (Durham, NC)
- …with a maximum lift of 20 poundsAbility to access and use a variety of computer software Ability to communicate information and ideas so others will understand, ... for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass… more
- BioAgilytix (San Diego, CA)
- …with a maximum lift of 20 poundsAbility to access and use a variety of computer software Ability to communicate information and ideas so others will understand, ... You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing...budgets and resources, and being the expert in using tools/ software relevant to the team.Work closely with clients to… 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
- Lundbeck (Bothell, WA)
- …a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey to… more
- Merck & Co. (Rahway, NJ)
- …preferred but not required.Proficient in computer -aided design (CAD) and computer -aided engineering (CAE) software such as SolidWorks, AutoCAD etc.Experience ... 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. (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
- 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
- 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
- ThermoFisher Scientific (Lebanon, TN)
- … activities spanning Process and Product Validation , Sterilization, Stability, and Computer Software Validation (CSV). This role necessitates a ... meet regulatory requirements, company procedures, and data integrity standards. Lead validation activities and impact assessments. We are seeking a highly skilled… more
- PCI Pharma Services (Bedford, NH)
- …management skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems/ software /equipment supporting GMP manufacturing ... management and reports; assist cross-functional team in identifying the required validation deliverables for new systems/ software /equipment or changes to… more
- Danaher Corporation (Muskegon, MI)
- …Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation (CSV) protocols and/or Plans and Reports. + ... + Experience in equipment qualifications, process validations, cleaning validations and computer software validations. + Previous experience in root cause,… more
- ThermoFisher Scientific (Greenville, NC)
- …Quality Validation : Govern validation activities for equipment, processes, computer software , and cleaning validation , ensuring compliance with ... to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong...Associate's degree is minimally required; A Bachelor's degree in Computer Science, Engineering, or a related field, or an… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …+ Assist with the creation of documentation for instrument qualification and computer software /hardware validation protocols and final reports in ... and execution of implementation requirements. + Assist with periodic reviews of computer system validation and instrument qualifications. + Assist with the… more
- Cordis (Irvine, CA)
- …multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation activities **Qualifications** + 7+ years as ... user stories, and test scripts; proficient with SQL for data validation . + Excellent facilitation, communication, and stakeholder-management skills. + Motivated to… more
- Cambrex High Point (Longmont, CO)
- …and approval of equipment and instrument validation as well as associated computer software validation . * Provide technical guidance for troubleshooting ... LIMS, MasterControl, Asset Management System, and Trackwise and/or other QMS software applications. Skills / Abilities: * Strong analytical and problem-solving… more
- Quality Consulting Group (Villalba, PR)
- …(2) years of relevant experience. + Process Validation , Equipment IQ and Computer software validation knowledge + Technical writing knowledge and ... Communication skills + Investigation and root cause analysis skills + Availability for 1st shift Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race,… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Crown Equipment Corporation (New Bremen, OH)
- Embedded Software Test and Validation Engineer (Indefinite US Work Authorization Required) Location: New Bremen, OH, US, 45869 **Company Description:** Crown ... in embedded software testing to contribute to Crown's Verification & Validation Team. Lead all design qualification and validation activities for new… more
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