Commissioning, Qualification and Validation

hace 1 semana

Madrid, España Takeda Pharmaceutical A tiempo completo

Job Title: Commissioning Qualification and Validation Technician

Location: Madrid - Tres Cantos

**About the role**:
**Objectives of position: Based at our Cell Therapy plant in Madrid, CQV Technician will be responsible to lead and manage site Commissioning, Qualification and Validation activities**:

- To ensure the correct Commissioning and/or Qualification and Validation of equipment, facilities, and utilities according to the plans of the manufacturing plant, and the current regulations,
- To ensure that all the equipment, facilities and systems are operating within user requirements and operating specifications, through CQV activities.
- To ensure compliance of equipment and systems with the technical regulations, safety rules, company policies, reference guidelines and cGMP regulations.

**HOW YOU WILL CONTRIBUTE**

**Key Accountabilities**
- Subject matter expert for instruments, equipment, systems & facilities validation, and qualification.
- Manage routine revalidation and revalidation tasks including production equipment, lab. equipment, HVAC, computerised systems, measuring instruments according to stablished and approved programs.
- Manage and organize external contractors and validation activities related to them.
- Preparation and review of qualification protocols and reports of equipment, facilities, and utilities with GMP impact, and execution of Validation/Qualification activities, including but not limited to (URS / RA / VP / DQ / FAT / SAT / IQ / OQ / PQ).
- Preparation and review of new/revised standard operating procedures (SOP’s), validation certificates, forms, flow diagrams, specifications, etc.
- Management and coordination of external personnel for the execution of qualification and validation tasks.
- Negotiation of qualification and validation services.
- Always maintain accurate records keeping equipment and systems cGMP compliant.
- Monitors and maintain contractors’ performance and work closely with outside vendors to ensure work is completed according to specifications.
- Participate in continuous improvement projects (efficiency, quality, energy saving and operating cost reduction).
- Act as the point person to the technicians while working closely with the manager to ensure strategy planning, implementations of plans, resolving problems while maintaining production quality.
- Ensure the follow-up and tracking of the validations. Update the validation documentation in the system
- Plan validation executions, and coordinate with other departments as necessary.
- Ensure the use of risk management tools to evaluate and mitigate risks associated with equipment and facilities.
- Support investigation and change control processes when needed.
- Complete mandatory training within required time frame.
- Perform other duties as assigned.

**Education and experience**:

- Minimum of a BS degree in Chemical, Biochemical or Mechanical engineering.
- A minimum of 3 - 5 years hands-on CQV activities, belonging to engineering department, and technical experience in a biopharmaceutical/pharmaceutical production environment.
- Minimum of 2 years of experience in writing, executing, and summarizing qualification protocols and testing procedures on CQV activities.
- Broad and in-depth knowledge of current Commissioning & Qualification approaches, methods, and protocols to evaluate relevant biopharmaceutical/pharmaceutical equipment, systems, facilities, and utilities.
- Demonstrated ability to lead troubleshooting activities and complex investigations and provide technical support services to both Operations and Quality.
- Demonstrated ability to successfully plan and execute improvement projects and validation activities within a dynamic production environment.
- Knowledge on Validations.
- Knowledge on equipment/systems qualification (HVAC, Cleanrooms, Gas systems, Controlled Temperature Units (CTUs) mapping, and Analytical Equipment qualifications.
- Knowledge of FDA, ICH, EU, PDA, ISPE, ASME (BPE) and other global regulations and GMP guidelines associated with validation requirements.
- Experience with/participation in internal/external audits.
- Experience with Microsoft Office Word, Excel and Sharepoint.
- Experience with computerized Compliance (Trackwise), Validation, and PM enterprise systems strongly desired.

**WHAT YOU BRING TO TAKEDA**:
**Skills and Competencies**

**Functional**
- Analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Able to handle multiple task/priorities and the ability to work under specific time constraints are required.

**Technical**
- Experience with protocol development and execution, deviation identification and resolution, and summary/final report authoring. Experience performing statistical analysis of validation test results.
- Sound industry knowledge and proficiency working in a project environment.
- Proficient in MS Off

  • Validation of Converters and Control Cabinets

    hace 1 día

    Madrid, España ISATI A tiempo completo

    **Main tasks**: - Define testing procedures to comply with certification requirements of converter and control cabinets for wind, solar, and battery markets - Design, adapt, and operate test rigs to proceed with the validation tests - Instrumentation definition, installation, and data gathering - Attendance to external laboratories to perform specific...

  • Mechanical Commissioning Engineer

    hace 7 días

    Madrid, España Mane Contract Services Limited A tiempo completo

    Our client is looking for a skilled Mechanical Commissioning Engineer to join their dynamic team. As a Mechanical Commissioning Engineer, you will play a pivotal role in ensuring the successful commissioning and deployment of mechanical systems within data center projects. You will be responsible for overseeing the testing, validation, and optimisation of...

  • Validation Engineer

    hace 7 días

    Madrid, España Connect Recruitment A tiempo completo

    **Validation Engineer - Relocate to Ireland** **Kilkenny, Ireland** **Role** It will be a very big plus if you can bring experience in developing projects or sites from square one. Responsible - The development and maintenance of Quality System procedures. - Ensuring the site delivers safe and effective products that meet customer needs whilst...

  • Commissioning Manager

    hace 3 días

    Madrid, España Nes Fircroft A tiempo completo

    Position: Commissioning Engineer Location: Spain Profile: Commissioning Engineer required to join the Grid Edge Solutions Team within Europe. As a Commissioning Engineer you will be required to execute the site activities working in coordination with the project team. Roles & Responsibilities:Execution of Battery Storage (BESS) and Microgrid projects...

  • Field Service Engineer for Erection and Commissioning

    Encontrado en: beBee jobs ES - hace 6 días

    Madrid, Madrid, España Burghardt+Schmidt GmbH A tiempo completo

    Über das UnternehmenWir sind ein international ausgerichtetes Maschinenbau-Unternehmen und stellen seit 1945 innovative Maschinen und Anlagen zum Schneiden und Richten von dünnen und empfindlichen Metallbändern her. Wir entwickeln und fertigen an unserem Standort in Remchingen kundenindividuelle Produkte mit höchstem Anspruch an Qualität und...

  • Commissioning Manager

    Encontrado en: beBee S ES - hace 2 semanas

    Madrid, España NES Fircroft A tiempo completo

    Position: Commissioning Engineer Location: Spain Profile: Commissioning Engineer required to join the Grid Edge Solutions Team within Europe. As a Commissioning Engineer you will be required to execute the site activities working in coordination with the project team. Roles & Responsibilities:Execution of Battery Storage (BESS) and Microgrid projects site...

  • Commissioning Manager

    Encontrado en: beBee jobs ES - hace 1 semana

    Madrid, Madrid, España NES Fircroft A tiempo completo

    Position: Commissioning Engineer Location: SpainProfile: Commissioning Engineer required to join the Grid Edge Solutions Team within Europe. As a Commissioning Engineer you will be required to execute the site activities working in coordination with the project team. Roles & Responsibilities:Execution of Battery Storage (BESS) and Microgrid projects site...

  • Commissioning Senior Manager

    Encontrado en: Talent ES C2 - hace 2 semanas

    Madrid, España Equinix A tiempo completo

    Who are we? Equinix is the world’s digital infrastructure company®, operatingover 250 data centers across the globe.Digital leaders harness Equinix's trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations to access all the right places, partners and possibilities to scale with...

  • Commissioning Senior Manager

    hace 2 horas

    Madrid, España Equinix A tiempo completo

    **Who are we?** Equinix is the world’s digital infrastructure company®, operating over 250 data centers across the globe. Digital leaders harness Equinix's trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations to access all the right places, partners and possibilities to scale...

  • Site Based Commissioning Manager Europe

    Encontrado en: Talent ES C2 - hace 19 horas

    Madrid, España Microsoft A tiempo completo

    Overview Microsoft Cloud Operations + Innovation (MCO+I) is the team behind the cloud. CO+I is responsible for delivering over 200 Microsoft web portals, Live and Online Services around the world including infrastructure, security and compliance, operations, globalization, and manageability. Our focus is on smart growth, high efficiency, and delivering...

  • Commissioning Engineer For Battery Storage And Microgrid Systems

    hace 2 días

    Madrid, España Hitachi Vantara Corporation A tiempo completo

    Description Commissioning Engineer for Battery storage and Microgrid systemsWe are looking for a Commissioning Engineer who will join our Grid Automation Business Unit.As commissioning engineer, you will execute the site activities working in coordination with project team.Your Responsibilities:Execution of Battery Storage (BESS) and Microgrid projects site...

  • Commissioning Engineer For Battery Storage And Microgrid Systems

    hace 3 días

    Madrid, España Hitachi Vantara Corporation A tiempo completo

    Description Commissioning Engineer for Battery storage and Microgrid systems We are looking for a Commissioning Engineer who will join our Grid Automation Business Unit. As commissioning engineer, you will execute the site activities working in coordination with project team. Your Responsibilities: Execution of Battery Storage (BESS) and Microgrid projects...

  • Commissioning Engineer For Battery Storage And Microgrid Systems

    hace 5 días

    Madrid, España Hitachi Vantara Corporation A tiempo completo

    Description Our Grid Edge Solutions Europe is part of the energy transition, helping our customers effectively manage renewables and distributed energy resources integration, deploy microgrids,and unlock new economic opportunities. Backed by more than thirty years of innovation and leadership in energy storage, management, and optimization our customers...

  • Commissioning Engineer for Battery storage and Microgrid systems

    Encontrado en: Whatjobs ES C2 - hace 2 semanas

    Madrid, España Hitachi Energy A tiempo completo

    Location:Madrid, SpainJob ID:R0040451Date Posted:2024-01-22Company Name:HITACHI ENERGY SPAIN, S.A.U.Profession (Job Category):Engineering & ScienceJob Schedule:Full timeRemote:NoJob Description:Our Grid Edge Solutions Europe is part of the energy transition, helping our customers effectively manage renewables and distributed energy resources integration,...

  • Commissioning Engineer for Battery storage and Microgrid systems

    Encontrado en: Talent ES C2 - hace 1 semana

    Madrid, España HITACHI ENERGY SPAIN, S.A.U. A tiempo completo

    Description : Commissioning Engineer for Battery storage and Microgrid systems We are looking for a Commissioning Engineer who will join our Grid Automation Business Unit. As commissioning engineer, you will execute the site activities working in coordination with project team. Your Responsibilities:   Execution of Battery Storage (BESS) and...

  • Commissioning Engineer For Battery Storage And Microgrid Systems

    hace 1 semana

    Madrid, España Hitachi Automotive Systems Americas, Inc. A tiempo completo

    Commissioning Engineer for Battery storage and Microgrid systems (f/m/d) page is loaded Commissioning Engineer for Battery storage and Microgrid systems (f/m/d) Apply locations Madrid, Spain Genova, Genova, Italy time type Full time posted on Posted 2 Days Ago job requisition id R0042871 Location: Madrid, SpainJob ID: R0042871Date Posted: 2024-02-16Company...

  • Eo Data Systems Validation and Verification Senior

    hace 1 día

    Madrid, España Deimos Space A tiempo completo

    **EO Data Systems Validation and Verification Senior Engineer** DEIMOS Space is looking for enthusiastic and proactive validation and verification manager to integrate Data Systems division, in Madrid. This is a fantastic opportunity to join a growing, innovative, employee-centred business in the space industry. **Main Duties**: EO Data Systems Validation...

  • EMEA Commissioning Lead

    Encontrado en: Talent ES C2 - hace 2 semanas

    Madrid, España Microsoft A tiempo completo

    Overview Microsoft’s Cloud Operations + Innovation (CO+I) organization is the engine that powers our cloud services. Our data center construction team is dedicated to delivering the highest quality data centers for our cloud services. As we continue to revolutionize the way construction projects are planned, managed, and executed, we are seeking a...

  • Mep Commissioning Manager F/M

    hace 2 semanas

    Madrid, España Cap Ingelec Sa A tiempo completo

    To support our growing activity in Madrid, we are looking for a MEP Commissioning Manager (F/M) to develop our team. With an intervention on design and build industrial and Datacenter projects from design to final handover, your main responsibilities will be: Lead and oversee the commissioning process, according to project timelines and specifications,...

  • Commissioning Manager

    hace 15 horas

    Madrid, España Linesight A tiempo completo

    Commissioning Manager - Electrical / Sub Station Bias - As a - **Commissioning Manager** at Linesight, you will work with highly experienced, culturally diverse, and passionate teams nurturing a strong social dynamic and a shared sense of achievement. You will gain vast industry experience that will open doors for you, extend your skillset and expand your...