- Novo Nordisk Inc. (West Lebanon, IN)
- … while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse ... software Work with PM to support the commission the system , ensuring all devices and systems are...correctly connected and functional Work with PM to conduct system testing and validation to ensure proper… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation 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… 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 ... systems (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices,… more
- Cytiva (Muskegon, MI)
- …next step to an altogether life-changing career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer will be ... strategy and maintain ownership of the Muskegon site Validation Master Plan.This position reports to the Quality...Performance Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation… more
- Aequor (Thousand Oaks, CA)
- …change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project ... priorities. 7. Excellent knowledge of and experience with processes involved in quality analytical labs, validation , manufacturing, quality assurance,… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... including audit and inspection management and oversight of the Quality management system . This role is responsible...and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical… more
- AUROBINDO (Durham, NC)
- …RequirementsProven expertise in reviewing and approving validation deliverables for key quality and laboratory systems such as LIMS, QAMS, Waters Empower, ... handling for validated systemsCompetent in test script and defect review/approval for system validation and ongoing complianceStrong collaboration with IT and… more
- Repligen (Waltham, MA)
- …developers, hardware engineers, and product management teams to validate that our integrated systems meet user expectations and quality standards. You will also ... and quality .Support the release process by validating build quality and readiness for production.QualificationsBachelor's degree in Computer Science,… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- BioAgilytix (Durham, NC)
- …timely response to all system alarmsDevelops, implements, and maintains EMS validation documents in internal Quality Management SystemsServes in the capacity ... responsible for implementation and oversight of all laboratory environmental monitoring systems (EMS) at BioAgilytix's Durham laboratories. He or she collaborates… more
- Merck & Co. (Durham, NC)
- …process automation in a GMP environment.Experience programming Emerson DeltaV. Computer system validation and systems life-cycle development methodology ... technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement,… more
- Merck & Co. (Durham, NC)
- …and oral Effective maintenance, troubleshooting, and problem-solving skills Proficiency in computer systems and applications including but not limited to, ... chromatography columns).Support Equipment (eg washers, autoclaves, tube welders/sealers). Automated Systems (eg Distributed Control System (DCS), Programmable… more
- Merck & Co. (Durham, NC)
- …Scheduling, Mechanical Maintenance, Preventive Maintenance, Prioritization, Process Improvements, Quality Standards, Regulatory Requirements, SAP Systems , ... filtration skids, chromatography columns, washers, autoclaves, or Clean-In-Place (CIP) systems .Compliance and Documentation:Takes ownership of cGMP compliance, ensuring adherence… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.-Position Description -This is a… more
- Merck & Co. (Durham, NC)
- …version 12+ required including Batch control Minimum of 4 years of GMP Computer validation and systems life-cycle development methodology experience ... systems , and develops strategies to optimize and ensure quality and stability of automation systems through...and ensure quality and stability of automation systems through future expansion, replacement, or upgrade. Assists in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager ... will need to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.The Maurice R. Hilleman Center for… more
- Merck & Co. (North Wales, PA)
- …in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical ... - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (North Wales, PA)
- …in ensuring that project plans are executed efficiently with timely and high- quality deliverables. Serve as the statistical programming point of contact and ... assigned projects. Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area (TA) standards and following… more
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