- 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
- Bristol Myers Squibb (Devens, MA)
- …maintenance, and responding to compliance requirements. + Strong knowledge of cGMP, FDA , EMA, and ICH cleaning validation requirements. + Experience with ... lives. Read more: careers.bms.com/working-with-us . **Position:** Senior Manager Cleaning Validation **Location** : Devens, MA **Key Responsibilities:** + Provide… 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
- Philips (Cambridge, MA)
- …architecture, and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on ... degree in information technology engineering or computer science. + Strong understanding of FDA validation , ITIL processes, and regulatory compliance. + You must… more
- Parexel (Boston, MA)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to ... join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated...updates, CMC changes). * Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.… more
- Astellas Pharma (Westborough, MA)
- ** Validation Manager** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Validation Manager** opportunity at their **Astellas Institute for Regenerative Medicine… more
- Stantec (Boston, MA)
- …the designs that support and enhance our communities. The Commissioning and Validation role provides crucial services to confirm equipment and facilities meet the ... hear from you. We have two immediate openings in our Buildings Commissioning/ Validation group for an enthusiastic, diligent and experienced Commissioning / … more
- Cognizant (Boston, MA)
- **About the role** As a Validation Lead - MES Serialization, you will make an impact by leading the testing and validation strategy for enterprise-level Document ... Systems, ensuring robust, compliant, and efficient processes. * Oversee interoperability validation to guarantee seamless integration across platforms and systems. *… more
- Medtronic (Boston, MA)
- …including warrantee, service, and repairs. + Experience implementing and adhering to FDA and computer systems validation requirements. + Demonstrated leadership ... in achieving shared objectives in a matrix organization, managing cross-divisional initiatives, and cross-functional teams + Highly organized, outcome oriented with excellent planning skills. + Excellent leadership, presence, and executive communication skills… more
- Medtronic (Danvers, MA)
- …industries + Knowledge of failure analysis techniques, material characterization, and process validation + Familiarity with FDA , ISO, and GMP requirements + ... Strong collaboration, communication, and problem-solving skills + Experience working with suppliers and contract manufacturers **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by… more
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