- Merck & Co. (Durham, NC)
- …safety, current Good Manufacturing Practices (cGMP) compliance and efficiency.Define requirements and specifications for equipment.Manage the implementation of new ... consistent manufacturing processes that meet current Good Manufacturing Practices requirements .Knowledgeable of all utility systems regarding functionally of equipment… more
- Merck & Co. (Rahway, NJ)
- …updates to data models as new sources are connected or regulatory requirements evolve.Data Product Support and Evolution: Develop and maintain data products that ... filing content. Collaborate with product owners and technical teams to gather requirements , test new features, and trouble shoot data related issues. Support user… more
- Merck & Co. (Boston, MA)
- …to ensure alignment with clinical development timelines and regulatory requirements . Most importantly, the role requires overseeing CDx development, ensuring ... stay up to date regarding industry trends and diagnostic regulatory requirements . Essential Job Requirements :Develop end-to-end diagnostic strategy in… more
- Merck & Co. (Rahway, NJ)
- …initiatives with overall business objectives and compliance requirements .Automation & Digital Technologies ImplementationOversee the selection, implementation, ... digital platforms and solutions that meet ISO-13845 standards and regulatory requirements .Build and maintain relationships with technology partners and vendors to… more
- Merck & Co. (North Wales, PA)
- …teams such as new statistical computing platform evaluation and development.Education requirements :Must have a Bachelor's degree (or US equivalent) in Computer ... plus 7 years SAS programming experience in a clinical trial environment. Requirements :Experience and knowledge in leading large and/or complex statistical programming… more
- Merck & Co. (Rahway, NJ)
- …of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out, anticipate, ... Inspire a learning culture and drive deep technical understanding.Minimum Education Requirements - One of the following:BS/BA degree in Biomedical Engineering,… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry ... standardsMinimum Education Requirements and Experience: Bachelor of Science (BS) in packaging,...with an ability to interrogate the science, identify true requirements , and detect critical flaws including ability to determine… more
- Merck & Co. (Rahway, NJ)
- …guidance to lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure ... inclusive of aligning the control and validation strategies. Minimum Education Requirements and Experience: Bachelor of Science (BS) in packaging/ mechanical/… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry ... standards Minimum Education Requirements and Experience: Bachelor of Science (BS) in packaging,...with an ability to interrogate the science, identify true requirements , and detect critical flaws including ability to determine… more
- Merck & Co. (Rahway, NJ)
- …Oversee lifecycle changes for MDCP packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure ... inclusive of aligning the control and validation strategies. Minimum Education Requirements and Experience: Bachelor of Science (BS) in packaging/ mechanical/… more
- Merck & Co. (North Wales, PA)
- …this role must have adept communication skills to effectively articulate insights and requirements about these subject areas with various teams to ensure clarity and ... knowledge, and creating new growth opportunities. Qualifications: Minimum/Preferred Education Requirements :Minimum:-Bachelor's degree in a relevant field such as Marketing,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for ... or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences… more
- Merck & Co. (Rahway, NJ)
- …successful candidate will have demonstrated understanding and experience of unique requirements of packaging system development of Medical Device and Combination ... coaching to team members Remain informed of current quality and regulatory requirements and industry trends as described in worldwide regulations and industry… more
- Merck & Co. (Rahway, NJ)
- …teams supporting the product.Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance ... programs across a variety of platformsExpert knowledge in global regulatory requirements for large molecule commercialization and BLA assemblyExpert knowledge in… more
- Merck & Co. (Rahway, NJ)
- …internal CMC community, collaborate with cross-functional teams to gather business requirements , and coordinate with IT, Research, and Manufacturing to capture ... operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated filing generation - Hands-on experience in… more
- Merck & Co. (Upper Gwynedd, PA)
- …gap between BAs/Stakeholders and Technical teamCollaborate with IT/vendors on business requirements for new or enhancement needs to support GCTO reporting.Build ... improvement to develop BI toolsVendor relationship management ensuring business requirements are clearly articulated and executed.Mentor and provide training to… more
- Merck & Co. (Rahway, NJ)
- …engineering and packaging science is applied to deliverables. Minimum Education Requirements and Experience: Bachelor of Science (BS) in packaging/ mechanical/ ... skills with an ability to determine interrogate the science, identify true requirements , and detect critical flaws including the ability to determine areas of… more
- Merck & Co. (Millsboro, DE)
- …as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturingPartner with our Company and CMO ... compliance within large molecule manufacturing industryExpert knowledge of GMP requirements for multiple regulatory agenciesExpert knowledge of large molecule… more
- Merck & Co. (Cincinnati, OH)
- …advanced degree (MD, PhD, DNP or PharmD), that is relevant to Virology and requirements of the position. --Experience- Minimum Requirements : -A minimum of 3 ... characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more… more
- Merck & Co. (Durham, NC)
- …of Predictive Maintenance tools and applications.Working knowledge of regulatory requirements in accordance with cGMP manufacturing operationsGood oral and written ... characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more… more
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