Grifols

Engineer

• Responsible for operating and maintaining utility equipment/systems such as boilers, cooling towers, air compressors, distillation units, pumps, valves and related systems such as water pretreatment, pure water, waste water, water for injection, plant vacuum and all media transmission sub-systems
• Day to day operations of Steam, Water Purification, Clean Air, Chilled Water, Refrigeration, Water for Injection, and Waste Water systems
• Operate and maintain Utility equipment such as boilers, cooling towers, air compressors, distillation units, pumps, valves and related systems such as water pre-treatment, pure water, water for injection, waste water, plant vacuum, and all distribution sub-systems
• Responsible for the safe, efficient operation of all systems under their control
• Make regular rounds of equipment areas, reading meters and gauges, listening to the machinery, and adjusting the controls required
• Perform tests and take corrective action as needed
• Responsible for troubleshooting equipment or systems and making or arranging for all necessary repairs
• Responsible each shift to keep log of test requests and results, instrument readings, plus any preventative or corrective maintenance work performed

Stationary Engineer

QA Engineer

• Coordinate and supervise the inspection and release of plasma lots for sale or further manufacture
• Verify critical systems and documentation associated with the destruction of plasma
• Ensure compliance to approved procedures
• Responsible for the quality acceptance and release of plasma product shipments
• Supervise daily activities of the quality assurance staff
• Ensure compliance with regulatory and customer requirements prior to release
• Review and verify temperature documentation
• Investigate and document deviations noted
• Participate in writing and revision of policies and procedures related to Source Plasma
• Monitor Plasma Operations for compliance
• Participate in internal audits

Supervisor, Plasma Quality Assurance

• Conduct feasibility studies for internal and external customers.
• Facilitate technology and process transfers from R&D and Manufacturing to and from Engineering.
• Facilitate Inter Company (GBI, IG, GTI) and Intra Company (Bioscience, Hospital, Diagnostics) technology and process transfers.
• Process scale-up and implementation.
• Support manufacturing and maintenance with process expertise.
• Process Engineering team member on capital projects.
• Makes independent decisions within defined areas of responsibility.
• Advances technical project proposals to senior management, following through to successful completion.
• Interacts frequently with senior technical peers.
• Sets levels of standard technical performance for others.
• Resolves conflicts with areas of responsibility.
• Sought for counsel within field of expertise for Process Engineering.
• Influences commitment of resources at divisional/departmental level.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Develops technical engineering standards.
• Ensures compliance with company and regulatory policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
• Focuses on fostering a best in class environment for the development, manufacture and regulation of biological products through availability and analysis of data, process understanding and Critical Quality Attributes (CQAs), utilization of process capabilities (maximize yield and throughput within CQA), continuous quality verification and continuous improvement.

Global Process Engineer – Upstream/Downstream

Manager

• Manage the day-to-day operations of the lab to ensure optimal laboratory performance
• Provide overall technical leadership, expertise, and support to the organization in validation and laboratory technologies
• Develop, oversee and maintain a validated production environment
• Write equipment, assay and process validation protocols; manage the execution of validation protocols
• Ensure strict adherence to SOPs, regulatory requirements, and company policies

Senior Manager, Laboratory Testing – HLA Testing

• Drives operational consistency, compliance and sustainability of standardized models
• Define, document, and update enterprise process standards
• Develop and partner with Field Leadership a compliance framework
• Establish and manage a maturity model assessing adoption of standard processes
• Use data to identify, assess, plan and lead process improvement opportunities
• Work closely with inter-departmental teams and Operations leadership
• Develop and implement solutions for donor centers
• Develop and deliver training, communication, and coaching programs

Performance Excellence Manager

Bilingual

• Perform physical examination and establish medical history to determine donor suitability
• Build rapport with donors to ensure overall customer satisfaction
• Ensure donor and staff confidentiality
• Responsible for donor awareness to potential hazards
• Provide donor education regarding general health and provide counseling regarding unacceptable test results
• Evaluate & manage donor injuries and adverse events
• Perform evaluations of any history of illness or medications to ensure continued donor suitability
• Assist in employee training
• Administer employee Hepatitis Vaccine program

EMT – Advanced, Bilingual in Spanish

Supply Chain

• Create and maintain a long term (12-18 month) master schedule
• Ensure raw materials and components are available to support production
• Communicate and lead others in achieving established plan
• Develop and execute capacity plan for designated manufacturing areas
• Analyze demand requirements including sales forecasts
• Monitor and communicate changes throughout the organization

Supply Planner

• Manage Plasma Supply Chain Operations activities associated with receipt, distribution, storage, and inventory control of raw plasma
• Oversee plasma receiving and scheduling activities, batch retrieval, lot assembly, and inventory updates
• System owner of Warehouse Management System and responsible for process improvements
• Accountable for cold storage logistics operation holding inventories valued between $60M and $150M
• Identify opportunities for operational efficiencies and drive implementation upon approval
• Establish performance objectives and measurements

Manager, Supply Chain Operations

Operations

• Maintain the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervise donor flow.
• Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
• Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP.
• Attend all required training sessions, staff meetings, etc.
• Ensures that accurate and thorough documentation of necessary records is performed.
• Under the guidance of the Center Manager and/or the Assistant Manager, assure facility is maintained in a neat and clean condition and all equipment is kept in good working order.
• Submit timely and accurate reports as required by the Center Manager and/or the Assistant Manager.
• Assist in the control of center donor funds as determined by the Center Manager and/or the Assistant Manager.
• Assist in the training of new employees and retraining of current employees.
• Maintains active communication with other service areas to ensure accurate documentation and quality.
• Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation.
• Reports all unsafe situations or conditions to area lead, supervisor or manager.
• May be trained to repair plasma center equipment.
• Assist the Center Manager and/or Assistant Manager in any task necessary in pursuit of company objectives.

Operations Supervisor

Compliance

• Accurately prepare regulatory applications required by federal and other regulatory authorities
• Research internal documents, complete applications, and forms; prepare cover letters and summaries
• Submit and monitor application submission for timely review and acceptance
• Provide updates to management on the status of applications
• Maintain files contemporaneously for transparency and timelines
• Maintain applicable shared mailboxes, dashboards and accounts related to administrative licensing activities
• Archive and distribute applications electronically and in hardcopy
• Educate and inform internal customers regarding regulatory requirements
• Assist with evaluation of regulatory changes for impact to the business

Regulatory Affairs Associate – Entry Level

• Liderar y coordinar flujos de trabajo de Biomat relacionados con la implementación del nuevo Centro Logístico de Plasma (PLC)
• Planificar, organizar y monitorear actividades del proyecto, asegurando la alineación de plazos, hitos, entregables, recursos y dependencias
• Coordinar equipos y partes interesadas multifuncionales, facilitando una comunicación y colaboración efectivas a través de la organización
• Impulsar la mejora de procesos, la estandarización, la digitalización y las iniciativas de Excelencia Operativa para mejorar el rendimiento operativo
• Monitorear el progreso del proyecto, identificar riesgos y problemas, y asegurar acciones de mitigación y seguimiento apropiadas
• Preparar y comunicar actualizaciones sobre el estado del proyecto, KPIs, materiales de gobernanza e informes ejecutivos para apoyar la toma de decisiones
• Asegurar el cumplimiento de los requisitos GxP, estándares de calidad y expectativas regulatorias aplicables a lo largo del ciclo de vida del proyecto
• Apoyar las iniciativas de gestión de cambios y el portafolio de proyectos, promoviendo la implementación exitosa y la adopción sostenible de nuevos procesos y formas de trabajar
• Facilitar la colaboración entre equipos multifuncionales y ayudar a impulsar la alineación, la responsabilidad y la disciplina de ejecución a través del proyecto
• Gestionar y/o contribuir a otros proyectos dentro del portafolio del proyecto Biomat, según sea necesario, asegurando la alineación con las prioridades comerciales, estándares de excelencia operativa y requisitos de calidad
• Contribuir al desarrollo de la estrategia de Excelencia Operativa y apoyar iniciativas de transformación empresarial más amplias.

Operational Excellence Specialist

• Serves as acting leader in the absence of the Center Manager as assigned.
• Maintains the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervisor donor flow.
• Oversees donor operations and supervise Operation Supervisor(s) and donor center staff during assigned shifts.
• Creates employee schedules to accommodate donor cycles.
• Determines the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center.
• Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies.
• Supports and executes daily operational plans to achieve center performance targets related to donor throughput, quality, and productivity.
• Partners with Center Manager and Quality team to identify and resolve deviations or operational concerns in real time.
• Monitors donor flow and proactively address delays or service issues to ensure an exceptional donor experience.
• Learns and maintains thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.

• Responsible for the life cycle management of R&D and Clinical documents according to company SOPs
• Participate in the implementation of new systems or improvements to existing systems
• Administer the clinical trial documentation system in compliance with regulations and procedures
• Responsible for maintaining and developing training profiles and documentation for Clinical departments

Clinical QA Systems, Documentation Specialist

Conversion Rate Optimizer

• Maintain operation of the site's utility generation and distribution systems
• Coordinate the activities of shift technicians
• Perform troubleshooting and maintenance of utility systems
• Implement and enforce site and Utility Operating Procedures
• Coordinate utility interruptions in normal and emergency situations
• Perform training of shift technicians in safety, machinery operation, repair and operating procedures
• Respond to DCS and BAS alarms, ensuring site operating equipment and space environmental conditions are maintained
• Manage utility complaint calls

Utility Control Room Operator 2/3

• Prepare and execute internal self-inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.
• Assisting in implementing Internal Audit plans for all Grifols manufacturing plants within North America.
• Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants within North America.
• Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses.
• Peer Review and approval of Audits Reports.
• Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
• Keeping abreast of industry standards and regulations.
• Contribution to the continuous improvement of the Quality Management System is required.

Stationary Engineer

Supervisor, Plasma Quality Assurance

Global Process Engineer – Upstream/Downstream

Senior Manager, Laboratory Testing – HLA Testing

Performance Excellence Manager

EMT – Advanced, Bilingual in Spanish

Supply Planner

Manager, Supply Chain Operations

Operations Supervisor

Regulatory Affairs Associate – Entry Level

Operational Excellence Specialist

Operations Supervisor

Clinical QA Systems, Documentation Specialist

Utility Control Room Operator 2/3

Senior Manager, Quality Audits