- Oracle (Augusta, ME)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Fujifilm (College Station, TX)
- …such as manufacturing operators, engineers,maintenance andcalibrations technicians, validation , quality,and external suppliersto providea high levelof excellence ... the CCMS/CMMS performance anduser'sutilization. + Work directly with Manufacturing, Validation , Quality Assurance, Metrology, Maintenance, Facilities, and Quality Controltosupport… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …area of responsibility. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... + Minimum of 2 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Requires an intermediate understanding of pharmaceutical… more
- Abbott (Pleasanton, CA)
- …in regulated industries (medical devices, pharma, healthcare). + Knowledge of FDA software validation processes. + Experience with real-time monitoring ... Security** : Ensure systems meet regulatory standards (eg, HIPAA, FDA CFR Part 11, ISO 13485). + **Observability** :...into application design. + Work closely with QA and validation teams to support software verification and validation… more
- Bristol Myers Squibb (Devens, MA)
- …in biologics or cell therapy manufacturing. + Strong understanding of CSV ( computer system validation ), data integrity, and regulatory requirements in laboratory ... the Cell Therapy Facility, including requirements gathering, design, implementation, validation , and ongoing support. + Oversee system integration with… more
- Curia (Albuquerque, NM)
- …and collaborate closely with cross-functional teams including Production, Maintenance, Quality, Validation , and Supply Chain. In addition, the candidate will provide ... performance. + Collaborate with cross-functional teams (Production, Maintenance, Engineering, Validation , and Quality) to ensure smooth operation and compliance with… more
- Insight Global (Westborough, MA)
- …as applicable. The role ensures these tools align with regulatory requirements (eg, FDA , IEC 62304, ISO 13485) and supports system access via Single Sign-On (SSO) ... SSO (Azure AD, Okta), enforce secure authentication and access controls. * Compliance & Validation : Support tool validation per ISO 13485 and 21 CFR Part 11,… more
- Fujifilm (College Station, TX)
- …drawings. . Ensure compliance with internal quality protocols, SOPs, cGMP, and FDA guidelines. . Collaborate with engineers and validation contractors to ... complex design and drafting for engineering, manufacturing, facilities, and validation . The role involves maintaining FDBT's engineering documents-including drawings,… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Establish master data architecture frameworks to enable system deployment, ensuring validation and regulatory compliance across FDA -regulated environments. + ... Comprehensive understanding of biopharmaceutical manufacturing processes, batch record requirements, validation standards, and change control procedures within FDA… more
- Abbott (Scarborough, ME)
- …knowledge of manufacturing equipment and processes. + Leads design of experiments, validation , completion of testing, and analysis of data. Presents data to ... manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, procedures, and other technical documents… more