- Sumitomo Pharma (Boston, MA)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems. + Manage Computer System Validation (CSV) activities in alignment with global regulatory ... **About the role** As a ** Validation Lead - MES Serialization** , you will make...standards ( FDA , EMA, MHRA). + Utilize ALM tools to streamline testing… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …in alignment with FDA and QSR standards. + Develop and execute validation plans for service test systems and methods. + AUTOMATION & WORKFLOW IMPROVMENT + ... TestStand, Python, or equivalent frameworks. + Establish test requirements, strategy, and validation approaches for new and existing test methods. + Troubleshoot and… more
- Oracle (Boston, MA)
- …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
- 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
- Philips (Cambridge, MA)
- …in information technology engineering or computer science. + Strong understanding of FDA validation , ITIL processes, and regulatory compliance. + You must be ... and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on key performance… 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
- 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… more
- Integra LifeSciences (Braintree, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Hologic (Marlborough, MA)
- …lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory ... innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. +… more