- Cognizant (Boston, MA)
- **About the role** As a ** Validation & Testing Lead in Life Sciences** , you will make an impact by driving the validation and testing strategy for Document ... to have to be considered:** + Deep knowledge of GxP regulations and global compliance standards (eg, 21 CFR...handling, CAPA management, and process harmonization. + Ability to lead cross-functional teams and manage validation deliverables… more
- Cognizant (Boston, MA)
- **About the role** As an **ALM** ** Validation Lead ** , you will make an impact by leading validation and testing initiatives across life sciences systems, ... and test strategies aligned with FDA, EMA, and GxP standards, supporting the transition to CSA. + Define...a focus on digital transformation and paperless execution. + Lead end-to-end validation and testing phases for… more
- Cognizant (Boston, MA)
- **About the role** **As an MES Validation Lead ,** you will make an impact by driving Computer System Validation (CSV) initiatives within the Life Sciences ... and business units. **In this role, you will:** * Lead validation strategy and execution for Document...to have to be considered:** * Deep knowledge of GxP regulations and global compliance standards (eg, 21 CFR… more
- Bristol Myers Squibb (Devens, MA)
- …qualification testing documents and associated testing deviations, providing escalations to CSV Lead as appropriate. + Review and approve validation lifecycle ... skilled and motivated Senior Engineer - IT Computer System Validation (CSV) to join our team at the Devens...reports for computer systems and software applications used in GxP environments. + Act as CSV Subject Matter Expert… more
- Bristol Myers Squibb (Devens, MA)
- …Bristol Myers Squibb is seeking an experienced and strategic Associate Director to lead the MES (Manufacturing Execution Systems) and Enterprise IT Systems at our ... implementation and maintenance of GMP-compliant digital solutions. **Key Responsibilities:** + Lead the design, deployment, and continuous improvement of MES and… more
- Sanofi Group (Cambridge, MA)
- …of combination products, design controls, design transfer, and manufacturing process validation + Manufacturing Program Lead of larger projects, proven ... GxP documentation and related Equipment Qualification and Process Validation of high throughput equipment. + Strong technical skills and familiarity… more
- ThermoFisher Scientific (Plainville, MA)
- …with confirmed competencies and strong character to join our team and help lead our organization into the future. **Location** Plainville, MA Position is Monday- ... Onboard new equipment with a cross functional team (procurement, validation ) How will you get there? **Required Skills** +...field required, with a minimum of 5 years of GXP or relevant experience + OR Higher Degree in… more
- Cognizant (Boston, MA)
- …and AVEVA recommendations. * Can develop and design PI Systems and nonGxP/ GxP Documentation without supervision. * Drafts Validation document lifecycle, ... evaluations. * In the absence on an EDL/SM, the Lead Engineer can assume the responsibility for conducting the...Minimum of 36 months of experience in programming and GxP environment. * 12 months of experience in supervising… more
- Bayer (Cambridge, MA)
- …trials, and overseeing digital capability enablement and operations. You will lead a cross-functional and global multimillion-dollar program to establish a ... execution for assigned technologies, including budget and resource distribution; + Lead a cross-functional and global multimillion-dollar program to establish a… more
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