- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … validation or qualification of global GxP and Non- GxP computer systems .Create and review various validation documentation such as Validation ... and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with… more
- Catalent (St. Petersburg, FL)
- … systems .Review and approve periodic reviews of local GxP systems .Other duties as assignedThe CandidateBachelor's degree in computer science, other STEM ... systems , automation, analytical equipment, and IT applications.Ensure that GxP systems comply with all applicable ...and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and general GxP… more
- BioAgilytix (Durham, NC)
- …develop project plans to implement automated solutions to support ( GxP ) validation and implementation, including protocol/throughput analysis; instrumentation ... systems . Serve as subject matter expert (SME) for select laboratory systems in a GxP environment.Authors Standard Operating Procedures (SOPs)Additional… more
- Eisai, Inc (Nutley, NJ)
- …in managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP . Leadership and Teamwork Strong track ... regionally. Education College diploma or university degree in the field of computer science, information science, management information systems , or business… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager, covering GxP and non- GXP systems : Drive and maintain IT Operations ... and follow-up beyond the organization, Tier 4) Analyze complex computer systems , identify problems, and develop and...IT Infrastructure SME for Quality assurance / GMP and Validation : Maintain qualified state of GxP IT… more
- Merck & Co. (Rahway, NJ)
- …and testing documentation in partnership with project CQV and IT teams.Establish GxP systems in the facility: Change Management, Maintenance protocols, ... Calibration procedures, Training, and SOPs for all GxP automation systems .-Integration of control systems with MES, Quality, and Batch Reporting… more
- Eisai, Inc (Nutley, NJ)
- …companies); Managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies. Send resumes to HR ... systems .. Requires: Master's degree or foreign equivalent in Computer Science, Information Technology Management, or Business Administration or closely related… more
- Merck & Co. (Rahway, NJ)
- …written.-Preferred:Experience with smart technologies, such as robots, automated systems and/or computer integrated manufacturing equipment ... Minimum:- BA/BS in Mechatronics, Engineering, Engineering Technology Automated Sciences, Computer Science, Biology, Chemistry or equivalent. (with expected graduation… more
- Catalent (Philadelphia, PA)
- …Quality operating procedures as needed. Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments, ... Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. Management responsibilities include professional development, performance...equipment, and systems used in GXP Operations throughout the… more
- University of Washington (Seattle, WA)
- …The Department of Laboratory Medicine and Pathology has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** ... manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status, and prioritize actions based on risk.… more
- Randstad US (Research Triangle Park, NC)
- …and go-live. + Partner with Validation and Quality to ensure that GxP systems are assessed, tested and documented appropriately, and support policy / ... gxp systems lead. + research triangle... gxp systems lead. + research triangle park , north...degree + category life, physical, and social science occupations computer and mathematical occupations + reference48063 job details job… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … validation or qualification of global GxP and Non- GxP computer systems .Create and review various validation documentation such as Validation ... **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non- GxP computer systems implementations in partnership with Global… more
- Bristol Myers Squibb (Bothell, WA)
- …Expert knowledge of cGMP, GDP, GXP , GAMP5 regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and data ... and system with validation document deliverable in respect to cGMP, GDP, GXP , GAMP5 regulations, including 21CFR Part 11, computer system validation … more
- Bristol Myers Squibb (Bothell, WA)
- …relevant GMP operations experience. + A minimum of 5 years of equipment qualification or computer systems validation experience. + A minimum of 5 years of ... in a biopharmaceutical environment. + Experience in use of computer systems related to validation ,...direct experience with providing GxP Quality guidance and support, or Validation … more
- Charles River Laboratories (Memphis, TN)
- …Sr. Engineer will have the experience to be functional lead responsible for Validation (CQV) deliverables for the facility, utilities, systems and equipment ... River Laboratories and all applicable regulatory requirements. + Responsible for Validation (CQV) deliverables for the facility, utilities, systems , and equipment… more
- Boehringer Ingelheim (St. Joseph, MO)
- …validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's ... (VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility...detail. + * This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for… more
- System One (Summit, NJ)
- …Knowledge of cGMP, GXP , GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + ... Job Title: Validation Engineer Location: Summit, NJ Type: Contract Responsibilities...+ Provides technical support and guidance on equipment and computer systems qualification and validations issues. +… more
- WuXi AppTec (Philadelphia, PA)
- …review, and approval of equipment/software validations (including Computerized Laboratory Systems ), System Life Cycle Documentation ( Validation Plans, Design ... approve Periodic Reviews. * Stay current with changes to GXP , including FDA and EU and other regulatory bodies...accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …environments; knowledge of Good Manufacturing Practices (GMP or GxP ) and Computer Systems Validation (CSV) is preferred. **Knowledge, Skills, Abilities** ... Education, Experience** + A bachelor's Degree in Information Technology, Computer Science, Cybersecurity, Business Management, Information Security, or a related… more
- BAE Systems (Richmond Heights, MO)
- …The Customer Technical Solutions team atGeospatial eXploitation Products ( GXP )provides on-site installation, customization, support, and training for the ... various GXP Platform, desktop and mobile products in environments ranging...problems in areas of video analytics, sensor data processing, computer vision, and machine learning. These products serve government… more
