- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing ... of cGMP processes for viral vectors.Take responsibility for the design and execution of purification process development studies.Independently design… more
- Twist BioScience (South San Francisco, CA)
- …with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated… more
- Twist BioScience (South San Francisco, CA)
- …and storage solutions.Background in assay development, genomics-based diagnostics, or quality control for high-throughput NGS data.Software Development & ... Senior / Staff Bioinformatics Production Scientist (Hybrid in South...combine genomics expertise with strong production engineering skills to design and implement robust, scalable computational pipelines for large-scale… more
- Twist BioScience (South San Francisco, CA)
- …minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high- quality DHF.Builds high morale ... teams and driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills… more
- Merck & Co. (Rahway, NJ)
- …individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and ... device design , requirement management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory… more
- Merck & Co. (Rahway, NJ)
- …utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory ... factory settingExperience with mathematical modeling, theoretical scaling calculations, and Quality by Design (QbD) principles.-Experience supporting/writing regulatory… more
- Merck & Co. (South San Francisco, CA)
- …developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate ... Metabolism, and Bioanalytics (PDMB) department of Research Laboratories is seeking a Senior Scientist specializing in AI/ML to support efforts in transforming the… more
- Formation Bio (New York, NY)
- …transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and decision-making across the ... thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and unstructured data into… more
- Merck & Co. (Rahway, NJ)
- … design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support ... possess extensive knowledge in medical device engineering, particularly in the design , manufacturing, verification, validation and associated quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management experience required. Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual ... excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? The Position The… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process...of five (5) years of engineering experience in maintenance, design , process improvement, or Six Sigma Green Belt certification… more
- Merck & Co. (Rahway, NJ)
- …standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong ... technical expertise in HVAC design , maintenance, and validation within a highly regulated environment,...requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site… more
- Merck & Co. (Rahway, NJ)
- …at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define ... industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a… more
- Merck & Co. (Durham, NC)
- …Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between ... First Time" mindset. Consistently deliver On-Time and In-Full - with First Pass Quality . Oversight and presence on the production floor at External Partner site(s).… more
- Abbott (Alameda, CA)
- …14971, 21 CFR Part 11 and IEC 62304. In particular, has knowledge of Design Control requirements. + Must have excellent oral and written communication skills. ... Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** The Sr Design Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D ... self. Become a **maker of possible** with us. The Sr Design Quality Engineer is...**Duties Include:** + Responsible for being the core team quality representative for design control … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …**Broader Duties** **for this role** **include:** + Responsible for being the core team quality representative for design control projects - new product ... **Job Description Summary** The Sr . Quality Engineer is a key...development as well as sustaining efforts. + Manage all quality aspects of the design control… more
- Hubbell Power Systems (Archdale, NC)
- Sr . Mechanical Design Engineer - Archdale,...AutoCAD desired. + Strong organizational skills in project planning, design , and quality control . + ... Hubbell Incorporated Job Overview Under the direction of the Design Engineering Manager, the Senior Mechanical ..., configuration, testing, and maintenance of electrical switching and control equipment. A Day In The Life + Participate… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- **Job Description Summary** Sr Design Quality Systems Manager reports to the Director, Quality Management, WWIPD. The Sr Design Quality ... and maintaining linkages between Risk Management and other processes such as Post Market Quality , Design Control , and Change Control . + Ensure… more
- Leidos (Portland, OR)
- …. + Panel Layout and Wiring Design . + Develop Bill of Materials Based on Design Criteria. + Quality Control Checks on Wiring Design . + Complete ... includes preparation of single-lines, schematics, and wiring designs for substations and quality control checks for wiring designs. Responsibilities will also… more
