- Merck & Co. (Rahway, NJ)
- …performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating ... ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation… more
- Merck & Co. (Rahway, NJ)
- …solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data warehousing more ... and Strategic Roadmap, supporting the organization's transition toward future-ready systems and modern data architectures. Primary Activities Design and develop… more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Merck & Co. (Rahway, NJ)
- …your rights, including under California, Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in office-based positions in ... the US will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization,… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... under California, Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in...office-based positions in the US will be working a Hybrid work consisting of three total days on-site per… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms ... under California, Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in...office-based positions in the US will be working a Hybrid work consisting of three total days on-site per… more
- Eisai, Inc (Raleigh, NC)
- …with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation, and reporting of quality goals and ... with applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to detail and ability… more
- Eisai, Inc (Nutley, NJ)
- …by Clinical OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRTAssist with tracking SAE safety reports, collating ... eTMF, Epic, EDGE, IRT, eDC and other Eisai internal systems as relevant Qualifications Bachelor's Degree (US) Proficient in...for the Clinical Trial Assistant (Onsite in Nutley - Hybrid ) is from :31-40Under current guidelines, this position is… more
- Merck & Co. (Rahway, NJ)
- …is responsible for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC ... systems comply with regulatory standards (eg, FDA, cGMP), maintain...analytics.Establish and monitor key performance indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Merck & Co. (Durham, NC)
- …and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment ... specification data within the computerized calibration and maintenance management system .Troubleshoots equipment and performs necessary repairs. Utilizes various instruments… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... improve performance.Apply technical skills and ingenuity to correct equipment and system problems that result in downtime or consume excessive maintenance resources… more
- Merck & Co. (Durham, NC)
- …PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical ... ability to follow complex instructions and use our Manufacturing Division's business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able to lift… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... or finished pharmaceutical environmentExperience in automation and manufacturing execution systems (MES), process modeling and process improvement.Mechanical functionality and… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Merck & Co. (Rahway, NJ)
- …is preferred):BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 20 ... development.MS/ MA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of… more
- Merck & Co. (Rahway, NJ)
- …from internal teams and provide training on vendor management and e-billing systems . Assist in firm rate negotiations, matter budgeting, and billing issues. Foster ... support and training for legal staff and outside counsel on the eBilling system and developing resources for new users. Implement solutions to streamline billing… more
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