- Abbott (Santa Clara, CA)
- …documents. + Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO and CR generation ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- J&J Family of Companies (Santa Clara, CA)
- …for preparation and execution of validation protocols and completion of validation reports. + Develops and maintains process risk documentation (eg, PFMEA) ... + Must be able to travel abroad to oversee the implementation process and the qualification- validation efforts. **Additional Information:** + The anticipated… more
- J&J Family of Companies (Santa Clara, CA)
- …of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for ... medical device treatment of atherosclerotic cardiovascular disease through its...activities to drive improvements with respect to hardware and equipment . This includes supporting project teams to ensure that… more
- Edwards Lifesciences (Irvine, CA)
- …reports for Engineering review + Lead and manage projects related to new equipment validation , equipment investigations, testing, objective evidence of ... is ready to dive deep into the intricacies of equipment , tooling, and extrusion process development. **How...following established protocols - to develop findings for the validation and improvement of equipment and manufacturing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of engineering projects related to aseptic drug product processing, facilities, and equipment + Pathfinding in the design, optimization, and problem solving of ... + Apply fundamental engineering principles to the design, development, scale-up, and validation of robust processes for sterile drug product unit operations (eg,… more
- Envista Holdings Corporation (Pomona, CA)
- …+ Develops or participates in establishing requirements for all verification and validation (design and process ) activities. + Apply state-of-the-art inspection ... required. + Participates in internal and external audits and inspections. + Maintains process and software validation plans. Writes validation protocols.… more
- Terumo Neuro (Aliso Viejo, CA)
- …other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation . Work closely with Manufacturing, Quality, Regulatory, and ... departments to oversee multiple process improvements to ensure readiness for process validation and alignment with company goals. + Evaluate, create, and… more
- Skyworks (Newbury Park, CA)
- …Drive IP design teams to ensure IP manufacturability and testability + Ensure process and temperature compensations strategies/circuits are in place + If trimming is ... communication across multiple sites and disciplines. Responsibilities Design-In Quality & Validation + Define, lobby for and enforce DFT/DFM methodologies and… more
- Hologic (San Diego, CA)
- …OQ, PQ) + Familiarity with process validation , analytical methods validation , cleaning validation , and equipment qualifications + Strong statistical ... compliance. Be a part of our mission to deliver safe and effective medical devices that enhance patient outcomes. **Key Responsibilities** + **Audit Coordination and… more
- Bio-Techne (San Marcos, CA)
- …implementation. . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process / equipment candidates for re- ... risk. . Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment… more