Job-ID Reference Remote50% Remote Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment. Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits. Establish preventive maintenance plans, calibration schedules, and critical spare parts lists. Author validation plans, validation protocols, test reports, including deviations and corrective actions and Standard Operating Procedures (SOPs). Utilize tools such as Minitab to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies. Perform equipment risk assessments, including pFMEA and hazard analysis. Define User Requirements Specifications (URS) for new equipment and lead equipment installation and commissioning efforts. Train technicians and operators on validated equipment procedures. Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations. Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines to high‐volume production. Work with Manufacturing Engineers to improve equipment reliability and throughput. Support internal and external audits by providing equipment validation evidence. Requirements: Bachelor's degree in mechanical, Electrical, Industrial, Biomedical Engineering, or a related field. 3+ years of equipment validation experience within medical device manufacturing. Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements. Familiarity with automated equipment, robotics, PLCs, and machine vision systems. Preferred Qualifications: Prior experience validating equipment for biosensor or electrochemical sensor manufacturing, or experience in the semiconductor industry for wafer production. Experience with high‐speed automation and semi‐automated production lines. Certification in equipment validation or GAMP 5 training.
...consultants are specialists focused exclusively on the healthcare executive recruitment market. With hundreds of years of combined experience and... ...they need when they need it. Although this is a remote position, participation in occasional in-person client meetings...
...Winery are seeking an experience Vineyard Manager to oversee the daily operations of our... ...passionate about viticulture, sustainable farming, and developing highperforming teams.As... ...and harvest.Assess grape maturity and work closely with the Winemaker to determine optimal...
Our client is looking for an Associate to join their Private Equity team.Essential to have experience in power, energy, or infrastructure2-5 years of experiencerole offers significant exposure to sourcing, diligence, financial modeling, structuring, financing, and portfolio...
...internal equity and alignment with market data.Crusoe is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, disability, genetic information, pregnancy, citizenship, marital status, sex/gender, sexual preference/...
Sanofi is seeking a Graphic Designer in Morristown, NJ to develop labeling artwork for U.S., Canada and global markets, adhering to regulatory... ...maintaining artwork libraries, supporting GMP-compliant packaging development, and providing technical MAC system expertise...