- Trimble (Dayton, OH)
- Your Title: Engineer: Verification and Validation Lead Job Location: Dayton, OH Our Department: CTCT Caterpillar Trimble Control Technologies (CTCT) is a joint ... position yourself for success. What You Will Do The Verification and Validation Lead Engineer will be part of CTCTs Electronic Hardware development team,… more
- Merck & Co. (Rahway, NJ)
- …programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Combination ... teams.Proven track record of applying analytical skills in product design, development, and validation .-Proven ability to lead team members of diverse skill sets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversees resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a ... centered around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation ,… more
- BioAgilytix (Durham, NC)
- …clear communication, and aligning project deliverables with client timelines and expectations. Lead assay development, validation , and sample analysis of ... for someone with a strong background in method development, GxP-compliant validation , and targeted and untargeted analysis using chromatography and mass… more
- EPM Scientific (Rockville, MD)
- The Cleaning Validation and Contamination Control Lead is responsible for defining and implementing robust, agile strategies for cleaning validation and ... will lead the continuous improvement initiatives of the cleaning validation and contamination control strategy and provide support during investigations for any… more
- Apptronik (Austin, TX)
- …the world around it. JOB SUMMARY We are seeking an experienced Senior Engineer to lead and execute our Product Validation roadmap and drive rigorous testing of ... love to speak with you. ESSENTIAL DUTIES AND RESPONSIBILITIES or KEY ACCOUNTABILITIES: Lead the development of Verification & Validation procedures and test… more
- BioAgilytix (Durham, NC)
- …Microsoft Power Automate to automate high-frequency, repetitive tasks, such as data validation and QC compliance checks.Establish automated data validation and ... into validated data.Maintain Audit-Ready Traceability: Ensure comprehensive data-lineage and validation documentation is always ready for FDA, EMA, or sponsor… more
- Merck & Co. (Rahway, NJ)
- …The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The ... GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities, and computer systems.- Prepare and… 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)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who work in… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Insmed Incorporated (San Diego, CA)
- …a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations ... and formulation development processes. Will support method transfer and validation as needed. Support the biotechnology product lifecycle, from early-stage… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... collaborations across our Company internal departments and key stakeholders.Ability to lead and champion organizational structure and be a change agent when… more
- Repligen (Rancho Dominguez, CA)
- …systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes projects or aspects of ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- BioAgilytix (San Diego, CA)
- …life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of preclinical, clinical, and ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Merck & Co. (Rahway, NJ)
- …with working closely with the group Director to define group strategy and to lead a team of scientists in solving complex analytical problems at the interface of ... in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills.… more
- Formation Bio (New York, NY)
- …the PositionAs AD/Director of Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data Science function, focusing on building ... while ensuring these capabilities evolve into robust, production-ready systems.Responsibilities Lead the Platform Science arm of Data Science, building predictive… more
- Merck & Co. (Durham, NC)
- …advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with site commercialization efforts ... Author or approve Change Control documentation for complex process, validation , analytical, equipment, facility/utility and/or automation changes. Managing on-time… more
- Eisai, Inc (Exton, PA)
- …suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting ... for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively3.… more
- Aequor (Devers, TX)
- …Months with High Possibilities of ExtensionDescriptionThe Cell Therapy SAP Sourcing Migration Lead is located in Devens, Massachusetts. This role will report to the ... Devens Associate Director, Cell Therapy Site Procurement Lead and will follow the Client Hybrid work schedule...approve all necessary UAT test scripts. DCT Verification and Validation : Approve Site Procurement Data Load Files in support… more
