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  •  ...Responsibilities:  Author, revise, and maintain SOPs and related controlled documents in accordance with regulatory and company standards....  ...document management systems (EDMS), including version control, approvals, and archival. Support internal and external audits... 
    Sugerido
    Tiempo completo

    Mentor Technical Group

    Manatí
    16 días atrás
  •  ...Job Title: CSV & Change Control Specialist Location: Manatí, PR Duration: 6‑month initial term (renewable up to 3 years) Position Overview WeilGroup is seeking two seasoned CSV & Change Control Specialists to support the Business Insights & Technology (BI&T)... 
    Sugerido
    Trabajar en la oficina

    Weil Group, Inc

    Manatí
    10 días atrás
  •  ...responsibilities to include, but not limited to the following: Inventory control (FIFO rotation, stock counts, cycle counts and manual...  ...postage meter. § Processes RGA's and informed Call Center customer credits to be process thru the system. Processes merchandise... 
    Sugerido
    Contratista
    Trabajar en la oficina

    Avantor

    Manatí
    8 días atrás
  •  ...(IOQ), Computer System Validation (CSV), Forms and SOP execution services.The resources will work with oversight from the Quality Control Laboratory, Computer System Validation Information Technology team, the Lab Management, and will interact on a regular basis with Engineering... 
    Sugerido
    Tiempo completo
    De duración determinada
    Trabajar en la oficina

    Cencora

    Manatí
    9 días atrás
  •  ...manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems. Knowledge on computerized system with data collection software (database). Strong knowledge of cGMP, GAMP,... 
    Sugerido
    Contrato
    Trabajar en la oficina

    QRC Group, Inc

    Manatí
    1 día atrás
  •  ...Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision and start-up.  Managing projects for Utilities, Fire Protection Systems, Lightning Protection, and Purified... 
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    Contrato
    Contratista
    Visa de trabajo
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Manatí
    4 días atrás
  •  ...Experience in: Project Management life cycle: Scope of Work, Cost Estimate, procurement, bidding process, scheduling, project control, contractor supervision, and start-up.  Managing Manufacturing projects  Understanding of pharmaceutical manufacturing processes... 
    Sugerido
    Contrato
    Contratista
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Manatí
    2 días atrás
  •  ...Decommissioning of a  temperature monitor sensor (System and Software), among others. Duties will include: Develop Change Control records, as required, following site Electronic Change Control (e-CC) Procedure. Perform Computerized System Validation (CSV)... 
    Sugerido
    Contrato

    QRC Group, LLC

    Manatí
    11 días atrás
  •  ...Insights and Technology (BI&T) Department in the following key activities or tasks, such as but not limited to: Develop Change Control records, as required, following Electronic Change Control (e-CC) Procedure for the Manati Site. Perform Computerized System Validation... 
    Sugerido

    Mirus Consulting Group

    Manatí
    8 días atrás
  •  ...and compliance. Review and revise Standard Operating Procedures (SOPs) as needed; approve document updates according to change control requirements. Provide coaching, support, and feedback on IT, CSV, and GMP compliance to relevant team members. Promote and support... 
    Sugerido

    Mirus Consulting Group

    Manatí
    12 días atrás
  •  ...@abbvie on  X ,  Facebook ,  Instagram ,  YouTube ,  LinkedIn and  Tik Tok . Job Description Purpose Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of site leadership team with a focus on... 
    Sugerido
    Temporal
    Tiempo completo

    AbbVie Inc.

    Barceloneta
    10 días atrás
  •  ...with an interdisciplinary team that may include Infrastructure Technology (IT), IT/CSV, Manufacturing Validation Team (MT), Quality Control (QC), Environmental Health & Safety (EHS), Engineering / Facilities, and Quality Assurance (QA). Equipment commissioning/... 
    Sugerido
    Trabajar en la oficina

    Mirus Consulting Group

    Manatí
    5 días atrás
  •  ...requirements and internal EHS policies. Conduct field inspections, issue work permits, and correct unsafe conditions. Quality Control & Issue Resolution Confirm installations meet engineering specifications and GMP standards. Lead conflict resolution among... 
    Sugerido
    Contratista
    Subcontratista
    Visa de trabajo

    Weil Group, Inc

    Manatí
    6 días atrás
  •  ...Coordinate with external consultants and internal resources to ensure timely document generation and execution. Manage change controls and deviations related to plants and equipment. Support maintenance and calibration functions to improve compliance and quality... 
    Sugerido
    Tiempo completo

    Mentor Technical Group

    Manatí
    8 días atrás
  •  ...utilities. Develop and execute IQ, OQ, and PQ protocols; compile FAT/SAT documentation. Automation & Controls Commission and validate BAS/SCADA control systems and HMI interfaces; test control logic and network communications. Support data historian integration... 
    Sugerido
    Contratista
    Trabajar en la oficina
    Trabajo por turnos

    Weil Group, Inc

    Manatí
    11 días atrás
  •  ...AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Proficient knowledge of computer system life cycle concepts, change control systems, and FDA regulatory requirements, including 21 CFR Part 11. Proven experience issuing and preparing Computerized Functional... 
    Contrato
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Manatí
    20 días atrás
  • For Change management services in the manufacturing area.  WHAT MAKES YOU A FIT:  The Technical Part: Bachelor in Life Science or Engineering with two (2) years of experience in a biopharmaceutical regulated Industry.   Excellent written and verbal skills in both...
    Contrato
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Barceloneta
    Hace un mes
  •  ...configurations to assure software works as expected before installing it in the user environment.  • Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environments.  • Assist on quality events investigations... 
    Turno rotativo
    Trabajo por turnos
    Fin de semana

    Weil Group, Inc

    Manatí
    6 días atrás
  • Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical...
    Tiempo completo
    CAS
    Trabajar en la oficina

    Mentor Technical Group

    Barceloneta
    Hace un mes
  •  ...11, and internal procedures. The specialists will collaborate with cross-functional stakeholders including Engineering, Quality Control, IT, and Quality Assurance to ensure successful planning, execution, and closure of all CQV activities. Key Responsibilities:... 
    Contrato
    Trabajar en la oficina
    Inicio inmediato
    Trabajo por turnos
    Fin de semana

    Weil Group, Inc

    Manatí
    2 días atrás
  •  ...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell... 
    Tiempo completo
    Turno de mañana

    Mentor Technical Group

    Manatí
    Hace 2 meses
  •  ...the duties of this job, the employee is regularly required to use hands to finger, handle, feel, or operate equipments, tools, or controls. The employee frequently is required to stand, walk, talk, or hear; sit; climb or balance, stoop, kneel, crouch or crawl; and smell... 
    Tiempo completo
    CAS

    Mentor Technical Group

    Vega Baja
    1 día atrás
  •  ...results of non-conforming product to identify causes, implements controls to eliminate causes, and assesses the success of the controls....  ...quality specifications and standards. Supervision and control of production processes to ensure they are carried out according... 
    Contrato
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Barceloneta
    4 días atrás
  •  ...impact assessments. Provide alternatives to resolve documentation situations. Establish project communication and documentation controls. Assure consistent quality of activities that meets or exceeds the requirements. Qualifications ~ Bachelor in Science... 
    Contrato
    Trabajar en la oficina

    QRC Group, Inc

    Vega Baja
    1 día atrás
  •  ...set standards ~ Make sure that any loose wires are connected and secured properly ~ Ensure calibration of thermostats and other controls ~ Perform checks on motors and belts and handle lubrication duties ~ Change filters and replace any parts as they wear out... 
    Tiempo completo
    CAS
    Inicio inmediato
    Fin de semana

    Mentor Technical Group

    Vega Baja
    9 días atrás
  •  ...and/or reduce cycle time per established procedures. Learns traceability and inspection requirements, learns statistical process control criteria. Assists engineers in collecting, compiling, measuring, organizing and recording data, and by writing procedures. May... 
    Contrato
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Dorado
    2 días atrás
  •  ...job) Evaluate and qualify product and process reworks by approved protocols and regulatory requirements. Review and revise controlled documents (e.g., SOPs, work instructions, protocols, batch records) as part of remediation efforts. Support impact assessments... 
    Contrato
    Trabajo por turnos

    Flexible & Integrated Technical Services, LLC

    Dorado
    29 días atrás
  •  ...designs. Design, develop, debug, modify, and test software using current programming languages and methodologies. Develop machine control software and integrate with controllers, vision systems, and instrumentation. Provide solutions to technical problems of... 
    Tiempo completo

    Boston Scientific Gruppe

    Dorado
    2 días atrás
  •  ...posición de Gerente de Proyectos . El/la gerente de proyectos controla y asigna los recursos del proyecto, planifica, dirige y coordina...  ...manejo del sistema Contract/Billing, Project Management y Project Control Analysis (PCA), preferible. Manejo del paquete Microsoft... 
    Tiempo completo
    Contrato
    Contratista
    Trabajar en la oficina

    BLDM, LLC

    Ciales
    2 días atrás
  •  ...El/La ingeniero de proyecto, asiste al gerente de proyecto en controlar y asignar los recursos del proyecto, planifica, dirige y coordina...  ...del sistema Contract/Billing, Project Management y Project Control Analysis (PCA), preferible. Manejo del programa de Microsoft... 
    Tiempo completo
    Contrato
    Contratista
    Subcontratista
    Lunes a miércoles

    Bldmpr

    Naguabo
    2 días atrás