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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)...SugeridoTrabajar en la oficina
- ...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...SugeridoTiempo completo
- ...services.The resources will work with oversight from the Quality Control Laboratory, Computer System Validation Information Technology... ...PR Education: Bachelor's degree or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/ Engineering...SugeridoTiempo completoDe duración determinadaTrabajar en la oficina
- ...upgrade project. Qualifications BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/... ...training in validation methodologies, technologies, and process control computer systems. Knowledge on computerized system with data...SugeridoContratoTrabajar en la oficina
- ...Technology (IT), IT/CSV, Manufacturing Validation Team (MT), Quality Control (QC), Environmental Health & Safety (EHS), Engineering /... ...minimum requirements to be considered: BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/...SugeridoTrabajar en la oficina
- ...with cross-functional stakeholders including Engineering, Quality Control, IT, and Quality Assurance to ensure successful planning,... ...Required Qualifications: Bachelor’s degree or higher in Chemistry, Biology, Microbiology, Engineering, Computer Science, or a related...SugeridoContratoTrabajar en la oficinaInicio inmediatoTrabajo por turnosFin de semana
- ...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...SugeridoContratistaTrabajar en la oficina
- ...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...SugeridoContratoContratistaVisa de trabajoTrabajo por turnos
- ...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...SugeridoContratoContratistaTrabajo por turnos
- ...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)...SugeridoContrato
- ...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
- ...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
- ...@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...SugeridoTemporalTiempo completo
- ...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...SugeridoContratistaSubcontratistaVisa de trabajo
- ...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...SugeridoTiempo completo
- ...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 rotativoTrabajo por turnosFin de semana
- 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...ContratoTrabajo por turnos
- ...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...ContratistaTrabajar en la oficinaTrabajo por turnos
- ...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...ContratoTrabajo por turnos
- 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 completoCASTrabajar en la oficina
- ...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 completoTurno de mañana
- ...improvements are achieved. Qualifications ~ Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) ~6 years in Quality Assurance, Compliance and Auditing with project management experience within...TemporalTiempo completoContrato
- ...Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Educación: #Asociado en una ciencia relevante, biología, química, disciplina ambiental o campo relacionado. # Grado técnico con años de experiencia o equivalente en el campo industrial...TemporalCASTurno de nocheTrabajo por turnosFin de semana
- ...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 completoCAS
- ...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...ContratoTrabajar en la oficina
- ...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...ContratoTrabajo por turnos
- ...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 completoCASInicio inmediatoFin de semana
- ...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...ContratoTrabajo por turnos
- ...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...ContratoTrabajo por turnos
- ...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