- Merck & Co. (Durham, NC)
- …facility is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate with ... the Technical Operations organization.Position Responsibilities: Reporting to the Director, Validation the incumbent will lead the team...to the Director, Validation the incumbent will lead the team of validation engineers responsible… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …may be available for elgibile candidates. Relationships Reports to: Lead Engineer, Validation (Supervisor) Essential Functions Primary responsibilities ... The Position The person in this role will also be responsible for validation activities in several areas of pharmaceutical manufacturing including, but not limited… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversees resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a ... centered around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation ,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …equipment maintenance/calibration Supports equipment qualifications or method verification/ validation activities Participates in deviations and laboratory ... Performs troubleshooting with support Contributes to cLEAN activities (eg PDCA, SPS, VSM) Lead or support projects with limited scope Documents and archives work in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technology adoption, articulating operational, financial, and compliance benefits to leadership. Lead or support process validation , regulatory submissions, and ... in improved commercial manufacturing processes and outcomes.The Director will build and lead a high-performing small team of technical experts, fostering a culture… more
- BioAgilytix (Durham, NC)
- …Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and ... into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA, EMA, or sponsor… more
- Merck & Co. (Durham, NC)
- …to experience the licensure and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong interpersonal, communication, ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.This… more
- Merck & Co. (Durham, NC)
- …be required to be fully vaccinated as a condition of employment.The Lead Maintenance Technician is a leader with strong interpersonal, communication, and ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders ... clinical data programming, reporting, data visualizations, external data acquisition and validation , and tools to support project portfolio across drug programs.… more
- Raytheon (Tucson, AZ)
- …for a full-time position of Principal Test Systems Integrated Product Team Lead (IPTL) located onsite in Tucson, Arizona. This position requires leading a ... for both hardware and test software development, integration, verification, validation , and maintenance activities within production, manufacturing, product qualification… more
- Raytheon (Tucson, AZ)
- …exciting opportunity for a full-time position of Senior Test Systems Integrated Product Team Lead (IPTL) located onsite in Tucson, Arizona. If you enjoy being in the ... for both hardware and test software development, integration, verification, validation , and maintenance activities within production/manufacturing/product qualification environments. Experienced… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who work in… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead , Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... images (vial, syringe, medical delivery device, bulk/flexible/rigid containers).- This individual will lead the AR&D CCIT strategy discussion and should be able to… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Aequor (Seattle, WA)
- …Have's a candidate should have are:Top Skills Required:Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration ... establishing the strategy for process changes, coordinating technical alignment, and lead implementation at a global level. This role collaborates across all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountability in data management practices. The position also involves risk-based validation of IT services and determining audit targets for GxP ... Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a… more
- Merck & Co. (Rahway, NJ)
- …play a crucial role in the supporting the development, analytical validation , and testing of histopathology-based assays for clinical implementation and advancing ... by our company's therapeutics.Collaborate in the development and analytic validation of digital pathology algorithms.Interface with scientists and physicians in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …including: equipment upgrades, new equipment installations, capital projects, and validation /commissioning support for new equipment installed onsite. This role will ... commensurate with candidate experience and qualifications. Relationships Reporting to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process… more
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