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  •  ...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)... 
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    Weil Group, Inc

    Manatí
    10 días atrás
  •  ...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... 
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    Tiempo completo

    Mentor Technical Group

    Manatí
    16 días atrás
  •  ...and Spanish (verbal/written).  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... 
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    Flexible & Integrated Technical Services, LLC

    Manatí
    2 días atrás
  •  ...and Spanish (verbal/written).  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,... 
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    Contratista
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    Flexible & Integrated Technical Services, LLC

    Manatí
    4 días atrás
  •  ..., issue work permits, and correct unsafe conditions. Quality Control & Issue Resolution Confirm installations meet engineering specifications...  ...pharmaceutical facilities. Familiarity with CAPEX budgeting, cost control, and estimate preparation. Weil Group is proud to be... 
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    Subcontratista
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    Weil Group, Inc

    Manatí
    6 días atrás
  •  ...South America. Responsibilities: Work with project teams to understand process, materials and volume assumptions. Prepare cost estimates based on defined scenarios following Company’s procedure. Estimate impact of CoGS in P&L. Prepare reclassification as... 
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    CAS
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    Mentor Technical Group

    Barceloneta
    Hace un mes
  •  ...@abbvie on  X ,  Facebook ,  Instagram ,  YouTube ,  LinkedIn and  Tik Tok . Job Description Purpose The Senior Cost Analyst is responsible for financial accounting, cost allocation, collection of data and preparation of reports that maintain AbbVie... 
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    AbbVie

    Barceloneta
    3 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,... 
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    QRC Group, Inc

    Manatí
    1 día 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... 
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    De duración determinada
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    Cencora

    Manatí
    9 días atrás
  •  ...De-trashing, Order processing, and shipping. Second level responsibilities to include, but not limited to the following: Inventory control (FIFO rotation, stock counts, cycle counts and manual monitoring of stock levels and usage). Work stock frequency reports to minimize... 
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    Contratista
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    Avantor

    Manatí
    8 días atrás
  •  ...Summary: We are looking for an experience Project Cost Accountant to be part of the project team that is working in a very ambitious...  ...’s procedure. # Estimate impact of CoGS in P&L. Cost Control # Work with Project Team to ensure correct cost allocations to... 
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    Trabajo híbrido

    CIS International LLC

    Barceloneta
    12 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)... 
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    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... 
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    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... 
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    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/... 
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    Mirus Consulting Group

    Manatí
    5 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... 
    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... 
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    Trabajo por turnos

    Weil Group, Inc

    Manatí
    11 días atrás
  •  ...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
  • 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...
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    Flexible & Integrated Technical Services, LLC

    Barceloneta
    Hace un mes
  •  ...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... 
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    Flexible & Integrated Technical Services, LLC

    Manatí
    20 días atrás
  •  ...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:... 
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    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
  •  ...regulatory requirements, achieve desired financial performance including cost reductions, and build a culture of high performance for the team...  ...as SAP. Familiarity with industrial automation (distributed control and PLC based systems). Experience in cross functional process... 
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    AbbVie

    Barceloneta
    5 días atrás
  •  ...Responsible for maintaining & implementing methodologies that includes cost efficiency, continuous improvement on process, services, and...  ...~3+ years of experience improving manufacturing and related controlled process. ~ Proven history in improving supply chain... 
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    El Comeback

    Dorado
    Hace 2 meses
  •  ...employee performance reviews, disciplinary actions, and track the progress of employee development plans/goals. Maintain department costs within budget guidelines. Provide technical assistance, support, and follow-up to Lead Operators in areas such as non-conformance... 
    Tiempo completo
    Empleo permanente
    Inicio inmediato
    Turno de tarde

    Heraeus Holding Gmbh

    Dorado
    2 días atrás
  •  ...Barceloneta location in the Abbott Vascular Division and support the FG Area . Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. As a Guide Wire Operator I you will provide support achieve the daily... 
    Por hora
    Práctica
    Temporal
    Tiempo completo
    Barceloneta
    3 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
    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
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    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
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    QRC Group, Inc

    Vega Baja
    1 día atrás