Gene Carreiro

Sr Manager, Automation Instrumentation & Controls @Biogen

Cambridge, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2018 — Present

Sr Manager, Automation Instrumentation & Controls @Biogen

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General Responsibility: Managing of all day to day Automation, Instrumentation & Controls, and Calibration activities. Assure site & cross-site Metrology programs meet domestic & foreign regulatory cGMP guidelines (e.g: FDA, EMA, etc.). Establishment and management of a safe, innovative, efficient, and effective service organization. Specific Responsibilities: Lead team supporting of Automation & SCADA systems management (e.g: DeltaV, iFix, PLC\'s, OSI Pi Historian, DAS, etc.), Global Business Process Owner (BPO) of Biogen Metrology Program, Global I&C CMMS Owner, Lead Global Cross-Site Initiatives, Leading the support for all, Automation/I&C Engineering, Instrument Calibration, Troubleshooting Repair, Preventive (PM) & Predictive (PdM) Maintenance, Scheduling, and Reliability Maintenance Efforts. Support for Process Automation, DAS (Data Acquisition System), Data Historian, CMMS (Computerized Maintenance Management System), Instrument Loop Specification, Installation, and Configuration. Quality System Support (e.g: 21 CFR part 11 compliance, Generation & Review of Deviations, CAPA’s, GCC’s, Planned Exceptions, Remedial Actions, and Instrument Criticality Risk Assessments). Foster a “Safety First” work environment (e.g: Enforce EH & S procedures, Department LOTO JP’s, Safety Training). Establishment and enforcement of company and department policies and procedures (e.g: Administrative, technical, personnel, quality, EH & S). Direct supervision of staff (i.e: Supervisors, Automation/I&C Engineers, Technicians, Leads, Administrative, Scheduler/Planner, and Contractors). Management of work activities, training, tools and equipment. Managing of departments Finances (e.g: Forecasting and Maintaining Annual Budget, Accruals, Re-Forecasting, Capital Projects, Procurement). Provide representation and support for program in audits (Internal & External Regulatory).

EDUCATION

2014

Bridgewater State University

BS, Management, General Management Concentration (Summa Cum Laude)

1986 — 1989

Community College of Rhode Island

AAS, Instrumentation Technology

SKILLS

U.s. Food and Drug Administration (Fda)GxpFdaBiotechnologyQuality SystemBiopharmaceuticalsV&VTechnology TransferStandard Operating Procedure (Sop)SopPharmaceutical IndustryInstrumentationCalibration21 Cfr Part 11TrackwiseVerification and Validation (V&V)CapaValidationU.s. Title 21 Cfr Part 11 RegulationAutomationComputer System ValidationAseptic ProcessingGmpGampCorrective and Preventive Action (Capa)Change Control

ABOUT GENE CARREIRO

Managerial Skills: Performance management, supervision, quality management, leading…

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