- Cardinal Health (Boston, MA)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Astellas Pharma (Westborough, MA)
- **Principal Computer System Validation Specialist** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every ... AIRM is headquartered in Massachusetts. Astellas is announcing a **Principal Computer System Validation Specialist** opportunity at their **Astellas Institute… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Engineer, IT Computer System Validation , Cell Therapy Devens role will provide ... the Devens Cell Therapy Facility (CTF) through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change… more
- Cognizant (Boston, MA)
- …and business teams. **In this role, you will:** + Develop and implement comprehensive validation and test strategies aligned with FDA , EMA, and GxP standards, ... 2+ years in a management role. + Expertise in Computer System Validation (CSV) and Computer...of ALM Test Management tools. + Deep understanding of FDA , EMA, GxP, and 21 CFR Part 11 requirements;… more
- Bristol Myers Squibb (Devens, MA)
- …Process Flow diagrams and Standard Operating Procedures. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Senior Manager Validation Engineering **Location** : Devens, MA **Key Responsibilities:** +… 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
- Insight Global (Danvers, MA)
- …a CSV Engineer for our medical device client in Danvers, MA. We are seeking a Computer System Validation (CSV) Engineer to ensure that all computer systems ... and enhance validation practices. -Create and implement validation plans for new and existing GxP computer...knowledge of regulatory requirements, including: 21 CFR Part 11 ,EU Annex 11, ISO 13485, IEC 82304, FDA CSA,… 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
- 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
- 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