- Merck & Co. (Durham, NC)
- …with talented and dedicated colleagues while developing and expanding your career.The Validation organization at our Durham, North Carolina facility is seeking to ... an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate with their colleagues in other areas of… more
- Aequor (Buffalo, NY)
- …to collaborate effectively with cross-functional teams. Key Accountabilties: Analyze capital project work Perform data validation Enforce controls policies ... Partner cross-functionally with Engineering teams SAP labor reporting and ad hoc analysis Perform month-end close activities: journal entries, accrual process ownership, ad hoc reporting Minimum Qualifications: Bachelor's Degree and 1&plus years or relevant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical data programming, reporting, data visualizations, external data acquisition and validation , and tools to support project portfolio across drug ... Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 requirements, industry best… more
- Merck & Co. (Sacramento, CA)
- …complex investigations and drive resolution of analytical technical issuesBuild and manage project plans, timelines, and schedules to effectively meet project ... working in the field of analytical testing, development, transfer, and/or validation ; ORMaster's Degree (MA/MS) with a concentration in biology, chemistry,… 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
- Twist BioScience (South San Francisco, CA)
- …requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing ... capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES solutions comply with GxP regulations… 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
- Eisai, Inc (Exton, PA)
- …(as required). The Associate Director sets strategic directions and project priorities, providing scientific leadership and oversight and managing individual ... suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting… more
- Aequor (Seattle, WA)
- …functional areas and drug product manufacturing sites to ensure project advancement, rapid and best-in-class execution, and communication of ... challenges/opportunities. The candidate will help drive the validation , qualification, and comparability strategies.Duties/ResponsibilitiesLead the commercial lifecycle plan… 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 ... potential compliance issues.Determine effective and efficient risk-based approaches for validation and qualification of IT services.In collaboration with Audits… more
- Eisai, Inc (Nutley, NJ)
- …of Eisai Clinical Computing Environment Support study migration, program validation , technical documentationManage J-Review set up, J-Review user access management, ... of relevant programming and application development experience, 5 or more years project management & people management experience Experienced in working in Medidata… 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 ... related issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation… more
- Aequor (Thousand Oaks, CA)
- …providing and communicating results, maintaining global process trackers, develop project plan, support Business Continuity and Risk Management objectives, and ... Services and Quality Systems teams to foster good communication throughout the project life cycle. 5. Ensure compliance - which includes implementing procedures that… more
- Merck & Co. (Rahway, NJ)
- …supplies under good manufacturing practices (including method development and validation as well as specification setting).-Authoring investigational new drug (IND), ... (NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding to agency questions.-Scientific… more
- Aequor (Tampa, FL)
- Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of ... QC chemist to provide the method technology transfer and project preparation work, make sure the project ...and regulatory audits as area SME. Develops and executes validation protocols for test methods and equipment qualification. Author… more
- Merck & Co. (North Wales, PA)
- …and safety evaluation.The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently ... 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)
- …evaluation. - The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with ... - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and process platform roadmapsDevelop key event milestones as part of project planning / oversight in support of tech transfer activitiesDrive cross-functional ... financial, and compliance benefits to leadership.Lead or support process validation , regulatory submissions, and regulatory inspection readiness related to… more
