- Fujifilm (Boston, MA)
- …to oversee all technical aspects of Synapse product implementation, fromsolution validation phases through product go-live. The Project Engineer (PE) must have ... NFS, CIFS, DAS. + Disaster Recovery (DR) setup and validation : Backupexec, NAS or Tape media. + Plan and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- J&J Family of Companies (Danvers, MA)
- …on Abiomed delivery forecasting + Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier + Partner with internal ... ERP systems (SAP preferred) + Demonstrated experience developing process validation plans, including IQ/OQ/PQ protocols/reports required. Experience designing and… more
- Zimmer Biomet (Braintree, MA)
- …GMP. + Preparing/Coordinating/Reviewing the testing results for product release, FDA submissions, foreign country product registrations, and compliance to current ... + Prepare/Review/Approve departmental documentation (Zimmer Work Instructions, test protocols, validation documents, technical reports, etc.). + Collect, enumerate, analyze… more
- Olympus Corporation of the Americas (Westborough, MA)
- …specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and ... the development of statistically sound design verification protocols/reports, design validation , and delivery system qualification activities + Lead the system… more
- Takeda Pharmaceuticals (Lexington, MA)
- …feasibility test development, in silico development, design verification and validation testing, risk assessments, DHF creation, general project team technical ... the development of statistically sound design verification protocols/reports and design validation . Support in maintaining the design history file and associated… more
- Teleflex (Chelmsford, MA)
- …activities in product and process design such as process development, process validation , test method development and validation , fixture design and ... * Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab or other statistical softwares. *… more
- Sanofi Group (Cambridge, MA)
- …to search deeper and solve sooner than ever before. Our team has released an FDA certified class II medical device titration application. We are gearing up for other ... requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer ... statistical analysis plans, CRFs, study reports) and processes. + Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and… more
- Bristol Myers Squibb (Devens, MA)
- …records. + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... in close proximity to strong magnets. + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred. **Basic… more
- Takeda Pharmaceuticals (Boston, MA)
- …indicators, and metrics to support greater efficiency, consistency, and validation of business processes and decision-making. + Provides recommendations on ... managing CROs (ie Smartsheets, and other MS software tools) + Solid understanding of FDA Good Laboratory Practices (GLP) for nonclinical studies as set forth in 21… more