- Catalent Pharma Solutions (Chelsea, MA)
- …manufacturing. The candidate provides expertise in automation engineering, design, and validation . The Senior Automation Engineer leads the design and implementation ... assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control… more
- Integra LifeSciences (Braintree, MA)
- …implement process-level efficiencies + Drive continuous improvement + Maintains all ISO/ FDA standard operating procedures, work instructions, and forms. + Maintains ... limited to, ECRs, DCRs, ECOs, DCOs, and MCOs. deviations, validation records, batch records, and notebooks. + Responsible for...such as batch records and validations + Have advanced computer skills to increase department productivity, as well as… more
- Sumitomo Pharma (Boston, MA)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Bristol Myers Squibb (Devens, MA)
- …their work + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
- Charles River Laboratories (Wilmington, MA)
- …code using skills in advanced SQL Programming: PL/SQL, T-SQL, U-SQL, that automates data validation ; + Review reports with results of data profiling on any new data ... minimum qualifications for this role: + Bachelor's degree in Computer Engineering, Computer Science, or any related...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
- Actalent (Auburndale, MA)
- …transferring designs to manufacturing, and overseeing verification and validation activities. Responsibilities + Plan and directly manage cross-functional ... as needed to maintain commitments. Essential Skills + Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and EU Medical Device Regulation.… more
- Sumitomo Pharma (Cambridge, MA)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Sumitomo Pharma (Boston, MA)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Cardinal Health (Mansfield, MA)
- …(DHF) Documentation and adherence to guidelines and requirements associated with FDA /QSR design controls. + Participate in multi-departmental teams to manage product ... system + Writing technical documents within an engineering environment, verification, validation , stability protocols, test reports and others. + Tests developments,… more