- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety, integration of ... GMP Cleaning coordination for all facility shutdownsCoordinates with Durham Site Engineering and Technical CoEParticipates in daily shutdown meetings ensuring… more
- Merck & Co. (Rahway, NJ)
- …activities are completed with the highest regard for safety, quality and regulatory compliance .Qualifications: Education: Degree in engineering or related ... in their approach to problem solving and talent development.Critical tasks involve technical and strategic oversight of chemical engineering staff who directly… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems, leveraging technical integrations and ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Catalent (St. Petersburg, FL)
- Compliance ManagerPosition SummarySt. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... independent audits; manage audit responses and observation resolution. Drive site compliance to regulatory , enterprise, and global requirements through building… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This position requires either ... and characterization, scale-up and activities to support technology transfer and regulatory filings. They are responsible for the management and development of… more
- Aequor (Thousand Oaks, CA)
- …cases and long term strategy. The Senior Engineer role will provide direct engineering technical support as follows: Demonstrating role modeling of leadership ... for hands on *STRONG* engineer experience with proper training/ background in technical side/ mathematics. NOT LOOKING for quality lab/ bench top/ science work.… more
- Merck & Co. (Rahway, NJ)
- …Division, and Global Workplace & Enterprise Services (GWES) to ensure compliance with regulatory requirements, corporate standards, policies and procedures ... site EHS strategy.Responsibilities:Plan, develop and implement EHS programs to ensure compliance with local, state and federal legislation.- Understand and mitigate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards ... compliance mindset and passionately drives continuous improvement Provides technical and managerial leadership in area of responsibility by effectively… more
- Merck & Co. (Rahway, NJ)
- …in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion of the Biologics portfolio from candidate ... bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… more
- Merck & Co. (Durham, NC)
- …Operations Manager will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations ... a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… more
- Merck & Co. (Durham, NC)
- …DescriptionThe individual in this role must provide direction, coaching, and technical expertise to maintenance and instrumentation technicians assigned to start up ... effectively with alternate shifts, site Maintenance & Utilities, and Reliability Engineering teams to share best practices, deliver training, and ensure consistency… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. -The Associate Principal Programmer will write… more
- Merck & Co. (North Wales, PA)
- …Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical Supplies (GCS), ... collaboration efforts, support and lead global projects in relation to:QUALITY & COMPLIANCE ACROSS GLOBAL CLINICAL DEVELOPMENT:Lead working groups of SMEs to ensure… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Durham, NC)
- …of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support, ... team culture including significant interaction with manufacturing, quality and engineering groups.- -Supports a large spectrum of sophisticated automated systems… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. The ... environment Experience in a cGMP environment (eg Production, Development, Process Engineering , Technical Services or related field) in pharmaceutical/ biotech… more
- Merck & Co. (Durham, NC)
- …process equipment operations. Takes appropriate action to correct Plant Engineering maintenance problems. Responsible for supporting our Manufacturing Division,- ... operation. This individual will partner with Quality Operations (QO) Lab Plant Engineering Management as well as the respective lab managers to provide equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Maintenance Support Specialist as part of the Facilities and Engineering team based in Raritan, NJ. Role Overview This position will be ... Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation functions in support of personalized cell therapy production… more
- Merck & Co. (Durham, NC)
- …to the performance and results of the department Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross ... and implementation of new systems which enhances the operation and/or engineering processesDecisions are guided by policies, procedures and business plan; receives… more
