- 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
- AbbVie (Worcester, MA)
- …Historian systems. Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). Mitigates risk within functions through sound design, early ... planning of automation systems. Maintain documentation including functional specification, validation protocols and change controls. Experience in change control,… more
- United Therapeutics (Durham, NC)
- …resource procurement and utilization Superior database maintenance / development experience Computer hardware / software validation and change control experience ... pulmonary arterial hypertension ( PAH ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( PAH ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... best practices Review and approve laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols,… more
- Astellas Pharma (Sanford, NC)
- …the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and ... includes yet is not limited to; equipment testing, SOP/batch record generation, validation protocol execution support, as well as cross site tech transfer… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …role will also support clinical/biomarker assay development and validation . For more information on CMC, click here ... and leadership for Takeda clinical and biomarker assay development and validation . Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to… more
- Amgen (New Albany, OH)
- …maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area. The work schedule for ... on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation , electrical and process automation issues. Assistduring regulatory agency… more
- Globus Medical, Inc. (Dayton, OH)
- …Functions : Supports product and process changes for qualification and validation requirements, and assists in change implementations Performs quality inspections, ... and general Design Control activities such as risk assessment, design verification and validation , as well as sterilization and packaging validation Assists with… more
- Globus Medical, Inc. (Methuen, MA)
- …Support design transfer from R&D to production under ISO 13485 and FDA guidelines. Regulatory & Quality Compliance Ensure adherence to IEC 62304 (medical ... cybersecurity standards. Maintain documentation for design controls, verification, and validation activities. Innovation & Research Stay current with advancements in… more
- Abbott (St. Paul, MN)
- …Work with design engineering in the completion of product verification and validation Work with microbiology to ensure appropriate environmental monitoring and that ... regulatory requirements. Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
