- 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
- Aequor (Libertyville, IL)
- …in a high-performing, business results-driven environment. Understanding of computer system validation . Familiarity with ERP systems (ie SAP or QAD), MES ... IT Systems integration and Agile Methodologies. Knowledge of cGMP, GXP , GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.… 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
- 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
- BioAgilytix (Durham, NC)
- …samples received, tested, and reported.Support revenue recognition activities, database systems , and resource planningSupport Validation and Sample Analysis ... constraintsStrong organizational and project administration skillsExperience working in a GxP environment preferredFamiliarity with NetSuiteEducation/ Experience:Bachelor's degree in life… 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)
- …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
- 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
- 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)
- …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
- Kelly Services (Tampa, FL)
- …a robust quality management system + Assist in the development and execution of validation protocols for computer systems and software applications + Conduct ... **Junior CSV Validation | Tampa, FL** **Contract-To-Hire (Full Benefits)** **_*This...ensure compliance with regulatory requirements, including FDA, ISO, and GxP + Provide training and support to end-users on… 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
- Insight Global (West Chester, PA)
- …and delivery with benefits delivered as committed required. Experience in GxP systems , Computer System Validation , and consistent track record in the ... engineers to design, develop, configure and test MES (Manufacturing Execution Systems ) solutions. They will be direct responsibility of leading resources contracted… more
- Pfizer (Groton, CT)
- …and Math). + Experience in solid dose manufacturing. + Experience in cleaning validation . + Experience with high purity water systems . + Experience with ... Will Achieve** We are seeking a highly motivated individual for the role of " Validation Engineer II" within Drug Product Supply (DPS) in Groton, CT. Our GMP… 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
- 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
- Catalent Pharma Solutions (St. Petersburg, FL)
- …be considered. + Pharmaceutical and/or life sciences experience including Computer System Validation , 21 CFR Part 11 and general GxP experience preferred. + ... control systems , automation, analytical equipment, and IT applications. + Ensure that GxP systems comply with all applicable GxP , legal, and fiduciary… more
