- Bristol Myers Squibb (Devens, MA)
- …to work and manage within a regulatory environment. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager, Cleaning Validation , Validation Engineering **Location** : Devens, MA… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and immunology. You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...11, GAMP 5, and Annex 11. **As a Senior Validation Specialist, a typical day might include:** + Planning… more
- Sanofi Group (Cambridge, MA)
- …with industry's best practices in bioanalytical assay development and regulatory expectations ( FDA and EMA) for validation of PK, immunogenicity and biomarker ... + Serve as system administrator for laboratory software and facilitate the validation and implementation of quality systems in the laboratory. + Program, maintain… more
- Stantec (Boston, MA)
- Senior Commissioning/ Validation Specialist - ( 250001UF ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design practice. ... the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key ... Responsibilities** + Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation … more
- Astellas Pharma (Westborough, MA)
- ** Validation Lead, Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Validation Lead, Quality Assurance** opportunity at their **Astellas Institute for… more
- AbbVie (Worcester, MA)
- …Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group. The ... renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA /GMP regulated environment. The engineer will work in a multi-disciplinary team… more
- Sanofi Group (Cambridge, MA)
- …teams to ensure that all integration processes adhere to the required validation protocols for FDA -compliant systems. Provide documentation and support for ... strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between...while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work closely with QA and… more
- Bio-Techne (Waltham, MA)
- …novel assays intended for diagnostic use at Exosome Diagnostics (ExoDx), + Verification/ Validation of assays that are FDA -approved, EUA-approved, FDA ... both internal and external collaborations. Technology transfer, operationalization, verification, and validation , of nucleic and protein assays are all in scope.… more
- Integra LifeSciences (Boston, MA)
- …documentation such as product requirements, schematics, verification, and validation strategy/execution. * Coordinate and review development documentation created ... SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. * Knowledgeable of and applies statistical analysis to… more