- Eisai, Inc (Nutley, NJ)
- …EDC, and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director ... industries, and system validation methodologies.Excellent technical skills in SAS system , JReview and application development .Provide technical guidance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …achieve analytics and insight delivery speed and efficiency through automation and GenAI application development . To help drive the AI CoE's mission, this role ... a track record of process improvement Industry Knowledge Experience in AI/GenAI application development for healthcare is preferred The base compensation range… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Global Security Operations - Americas. Will work closely with IT operations staff, application development teams, system managers, and line of business ... for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing… more
- Merck & Co. (North Wales, PA)
- … life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Twist BioScience (South San Francisco, CA)
- …or related field.Minimum of 8+ years of relevant industry experience in enterprise application development with a strong focus on Salesforce (SFDC).5+ years of ... RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San… more
- BioAgilytix (San Diego, CA)
- …deliverables (risk assessment, requirements specification, IQ/OQ/PQ, etc.) Contributes to the development and revision of Computer System Validation procedures ... field Not less than five (5) years' experience supporting scientific and enterprise systems , including but not limited to: application servers, Active Directory,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device ... Development & Technology (DD&T) Team designs, develops, and commercializes...REQUIREMENTS: BA/BS in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering,- or other types of engineering plus 10… more
- Lundbeck (Bothell, WA)
- …Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC ... Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial… more
- Insmed Incorporated (San Diego, CA)
- …build out the process development support testing function within analytical development . Will develop systems and processes to facilitate rapid, high ... program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take… more
- Merck & Co. (Rahway, NJ)
- …engineering, IT or related discipline with functional working experience in System Development /Management within Manufacturing or Research areas preferred.Start ... Information Management organization.Primary area of responsibilities will include:Project support for System Development , Maintenance, Enhancement and System … more
- Merck & Co. (Rahway, NJ)
- …other regulatory requirements.Lead the operation of the site BAS and HVAC control systems . Manage the development and oversight of site operations through data ... and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. -...Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain… more
- Twist BioScience (South San Francisco, CA)
- …DescriptionWe are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development , implementation, ... Cycle (SDLC) for our custom MES, including detailed requirements gathering, system design, coding standards, development , rigorous testing, validation,… more
- Merck & Co. (Rahway, NJ)
- …including critical program needs related to new products undergoing process development , new products undergoing scale-up, launch and transfer to the supply ... Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, ... delivery to their intended site of action. The DPPD Team manages the development and commercialization of the device constituent and combination product of our… more
- Repligen (Boston, MA)
- …competitive edge.Collaboration: Collaborate with internal teams, including marketing, product development , customer service, field application specialists, and ... advancements that shape the future of bioprocessing.ResponsibilitiesResponsibilities:Sales and Business Development : Drive sales and business development activities… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... to resolve problems that cross into inter-related unitsAssist in the identification, development , and implementation of new systems which enhances the operation… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will… more
- Merck & Co. (Rahway, NJ)
- …packages to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such ... Validation, Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department… more
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