CQ SME Senior Engineer

vor 2 Wochen

Bern, Schweiz Project Delivery Partners Vollzeit

Job Summary

The scope of CQ activities relates to Fill Finish and Process Support Equipment, where schedule allows.

The CQ FF SME is responsible for coordinating CQ related activities including supporting Documentation Preparation, FAT, Installation, Hook Up, MC Oversight, active CQ Execution involving Safe / LOTO Team, Various Vendors, Calibration Group, Automation, CQV Team and USER - Ops and QA Team.

Main Responsibilities

General Management and Coordination

  • Meeting and delivering key project milestones
  • Implementation of CORP-35 and supporting guidelines
  • Adherence to EU Annex 15
  • Actively Support CQ Documentation (FRAs, DQs, Gap Assessment, Lonza Commissioning, IQs and OQs)
  • CQ Execution Readiness (Permits, Availability of Materials and Consumables, Tooling, Calibrations, Utilities, Ops support, Automation support and CQV support)
  • Hands On CQ Execution (Vendor Oversight, Execution of Commissioning Protocols, IQ and OQ Test Plans)
  • Participate in MC, P+ID Walk down and Punch item Categorisation
  • Deviation/Incident Management & Change Control (Process)
  • Punch List Management
  • Vendor Management & Management of Third Party Support
  • Reviewing CQ test plans and specifications prior to their approvals and post execution
  • Management and Filing of CQV related documentation
  • System and Area Handover

Main Responsibilities and Tasks Relating to CQV Documentation:

  • Coordinating development and approvals with the Client, Construction QA lead, and with other disciplines including Vendors, Automation, E+I, and USER etc.
  • Developing positive working relationships with team members and USER groups
  • Ensuring adherence to schedule, manhours and quality
  • Review and approval of VTOD and CTOD
  • Generation (Kneat digital platform) & execution of commissioning & qualification protocols
  • Actively support Doc Prep team within the Kneat Systems
  • Risk Assessments, GAP Analysis, DQ Execution
  • Review of Vendor Docs incl FAT and SAT, IQ and OQs
  • Development of Lonza CTPs, IQ and OQ

Execution Readiness:

  • FAT support where requested
  • Documented training on PSPs
  • CQ Team development and resource allocation
  • Monitoring and coordinating MC readiness
  • CQV documentation readiness
  • Monitoring and coordinating Automation readiness
  • Monitor and coordinate SUT installation
  • Appointment of Sub Contracts
  • Calibration readiness including test equipment and resourcing
  • HSE Plans, System PSSRs and LOTOTO device readiness
  • Vendor notification of SAT dates per CQ Schedule
  • Materials, consumables, spares, first fill available in stores
  • Ensuring the fulfilment of the general pre-requisites, needed to start with CQV execution

CQV Execution:

  • Ensure daily multidisciplinary CQV, Eng, CM and USER coordination meetings are established
  • HSE management in conjunction with HSE Lead
  • MC acceptance
  • Coordinate CQV execution activities in conjunction with Vendors and Lonza Automation Group
  • Execution of commissioning test protocols, IQ and OQ
  • Vendor Management during SAT (Scheduling, Arrival On site, HSE Induction, SAT, IQ and OQ Oversight, Training, Handover)
  • Ensuring compliance of the commissioning activities with qualification requirements where test results are subject to leveraging (FAT, VTOD, CTOD and SAT)
  • Tracking of changes, punch items and deficiencies
  • Reviewing first of type CQ test reports prior to their approvals
  • Assisting system leads/engineers with system handover to production
  • PQ and PPQ support where necessary

Project Controls:

  • Planning & Scheduling
  • Support with overall System based baseline CQV Schedule in conjunction with Engineering, CM and USER Group involving;
  • System Definition & System Classification
  • MC alignment with Construction
  • Handover alignment with USER
  • Fortnightly updates to CQ schedule including actualized and forecasting data for Doc Prep and Execution Phases
  • Input to monthly project report including but not limited to:
  • Progress Reporting & Progress measurement
  • Scope changes
  • Risks, Challenges and Mitigations

Key Performance Indicators:

  • Strong knowledge and experience of Process Commissioning and Qualification Fill Finish and Process Support Equipment
  • Management: Compliance with a schedule at a system and area level with the planned resource levels.
  • Positive Feedback from Customer (i.e. Quality, HSE, operations)
  • Safety: No lost time accident and Focus on Start Up Safety
  • Equipment Functionality: Robust and Repeatable Commissioning with no spurious alarms in line with URS, Technical and Functional specs. Well-executed Kneat Test protocols with minimum rework, deviations and re-execution
  • Quality: Compliance with GDP, all deviations resolved to Client satisfaction and handover completed for all systems.
  • Project Controls: Support with scheduling, punch item management, reporting and progress measurement
#J-18808-Ljbffr

  • CQ Engineer

    vor 2 Wochen

    Bern, Schweiz Project Delivery Partners Vollzeit

    Job Summary:The CQ Engineer is responsible to support Doc prep (KNEAT) and execution as it relates to CM oversight, MC acceptance, CQ execution and successful handover to the Client USER team.The scope of CQ activities may relate to Utilities, Process and Process Support Equipment. The CQ Engineer will report to the CQ Area Owner.Main responsibilitiesGeneral...

  • CQ Engineer

    Vor 6 Tagen

    Bern, Schweiz Project Delivery Partners Vollzeit

    Job Summary: The CQ Engineer is responsible to support Doc prep (KNEAT) and execution as it relates to CM oversight, MC acceptance, CQ execution and successful handover to the Client USER team. The scope of CQ activities may relate to Utilities, Process and Process Support Equipment. The CQ Engineer will report to the CQ Area Owner. Main responsibilities ...

  • Senior Software Engineer Robotics C++

    vor 2 Wochen

    Bern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Senior Software Engineer Robotics C++, BernClient:Guided SolutionsLocation:BernJob Category:OtherJob Reference:e8f89a277087Job Views:13Posted:19.02.2025Expiry Date:05.04.2025Job Description:Our customer is a leading Swiss SME and developer of cutting-edge High-Tech Medical Device technology. A disruptor in their...

  • Senior Software Engineer Robotics C++

    Vor 5 Tagen

    Bern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with: Senior Software Engineer Robotics C++, Bern District Client: Guided Solutions Location: Bern District Job Category: Other Job Reference: e8f89a277087 Job Views: 4 Posted: 03.03.2025 Expiry Date: 17.04.2025 Job Description: Our customer is a leading Swiss SME and developer of cutting-edge High-Tech Medical Device...

  • Senior Software Engineer Robotics C++

    Vor 6 Tagen

    Bern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Senior Software Engineer Robotics C++, Bern DistrictClient:Guided SolutionsLocation:Bern DistrictJob Category:OtherJob Reference:e8f89a277087Job Views:4Posted:03.03.2025Expiry Date:17.04.2025Job Description:Our customer is a leading Swiss SME and developer of cutting-edge High-Tech Medical Device technology. A...

  • Senior Network Engineer

    Vor 5 Tagen

    Bern, Schweiz Cloudsecurityexpo Vollzeit

    I am hiring on behalf of a Swiss-based tech company, facing lots of success and on a growth surge currently. They are searching for a Senior Network Engineer to implement and develop their SASE service.The company specializes in innovative solutions for data security and privacy, with a focus on developing cutting-edge encryption technologies and secure...

  • Senior Network Engineer

    Vor 6 Tagen

    Bern, Schweiz Cloudsecurityexpo Vollzeit

    I am hiring on behalf of a Swiss-based tech company, facing lots of success and on a growth surge currently. They are searching for a Senior Network Engineer to implement and develop their SASE service.The company specializes in innovative solutions for data security and privacy, with a focus on developing cutting-edge encryption technologies and secure...

  • Senior Network Engineer Cisco

    Vor 6 Tagen

    Bern, Schweiz TN Switzerland Vollzeit

    Senior Network Engineer Cisco, Bern DistrictSenior Network Engineer CiscoUnser Kunde ist eine führende IT-Unternehmung für Netzwerk-, Security- und Collaboration-Lösungen. Sie suchen im Zuge ihres Wachstums an den Standorten Zürich und Bern mehrere Senior Network Engineers Cisco.Ihr Verantwortungsbereich:Konzeption, Design und Engineering von komplexen...

  • Senior Network Engineer Cisco

    Vor 6 Tagen

    Bern, Schweiz TN Switzerland Vollzeit

    Senior Network Engineer Cisco, Bern District Senior Network Engineer Cisco Unser Kunde ist eine führende IT-Unternehmung für Netzwerk-, Security- und Collaboration-Lösungen. Sie suchen im Zuge ihres Wachstums an den Standorten Zürich und Bern mehrere Senior Network Engineers Cisco . Ihr Verantwortungsbereich: Konzeption, Design und Engineering von...

  • Senior Frontend Engineer

    vor 2 Wochen

    Bern, Bern, Schweiz ONE Agency | IT Recruitment Experts Vollzeit

    ONE Agency | IT Recruitment ExpertsSenior Frontend Engineer (w/m)Über unseren KundenUnser Kunde schaft digitale Erlebnisse und erstklassige E-Business-Lösungen, und das seit über 20 Jahren.Ihr Aufgabenbereich- Umsetzung responsiver Webseiten mit hoher Komplexität- Optimierung auf Barrierefreiheit und Performance- Beratung und Unterstützung in der...

  • Senior Systems Engineer Cloud

    vor 1 Woche

    Bern, Schweiz TN Switzerland Vollzeit

    Senior Systems Engineer Cloud / WorkplaceDu möchtest maßgeblich an der Solution Architektur und dem Engineering von innovativen Technologien beteiligt sein und treibst anspruchsvolle Kunden- und Service-Integrations-Projekte voran? Unser Kunde, ein innovativer Schweizer IT Dienstleister für verschiedene Banken, ist auf der Suche nach einem Senior System...

  • Senior Requirements Engineer

    vor 4 Wochen

    Bern, Schweiz Coopers Group AG Vollzeit

    Senior Requirements Engineer - AnlagelösungFür unseren Kunden aus der Finanzbranche in Bern, suchen wir eine:n erfahrene:n und aufgeschlossene:n Senior Requirements Engineer - Anlagelösung.Ihre Aufgaben:Analyse der internen und externen (IT-System-) Umgebung im Bereich AnlagelösungenDurchführung von Expertengesprächen, Workshops und Interviews mit...

  • Senior Cloud Operations Engineer

    Vor 7 Tagen

    Bern, Bern, Schweiz AmerisourceBergen Global Services Vollzeit

    Job Description:About the Role:AmerisourceBergen Global Services is looking for an experienced Senior Cloud Engineer to manage and execute the necessary operations for the delivery of Data Services to global pharmaceutical manufacturers.Key Responsibilities:Design, Develop, and Implement Cloud InfrastructureCollaborate with Director, Application Services and...

  • Senior Software Engineer mit Entwicklungswunsch Cloud

    vor 2 Wochen

    Bern, Schweiz TN Switzerland Vollzeit

    Senior Software Engineer mit Entwicklungswunsch Cloud, BernSenior Software Engineer mit Entwicklungswunsch CloudÜber unseren KundenFür unseren Kunden, der sich kontinuierlich weiterentwickelt und damit einen einzigartigen Mehrwert schafft, suchen wir einen Senior Software Engineer mit Fokus auf Cloud-Technologien.Ihr AufgabenbereichSie sind maßgeblich bei...

  • Senior Test Engineer TWINT WL

    vor 4 Wochen

    Bern, Schweiz My Swisscom Vollzeit

    Join to apply for the Senior Test Engineer TWINT WL role at Swisscom.As a Senior Test Engineer, you ensure the quality of TWINT integration for over 60 TWINT white label banks. You prepare, carry out and document all tests. You will combine manual, automated, integration and end-to-end tests.ResponsibilitiesResponsible for high quality on popular dynamic...

  • Senior Software Engineer Java

    vor 2 Wochen

    Bern, Bern, Schweiz ONE Agency | IT Recruitment Experts Vollzeit

    ONE Agency | IT Recruitment ExpertsSenior Software Engineer JavaÜber unseren KundenUnser Kunde ist einer der führenden Versicherungsunternehmen der SchweizIhr Aufgabenbereich- Sie übernehmen bei der Mobiliar eine absolute Pionierrolle und helfen beim Aufbau und der Integration der neuen Datenlogistik-Plattform mit.- Sie konzipieren, entwickeln und...

  • Telcom Sytem Engineer

    vor 2 Wochen

    Bern, Schweiz FOXJOBS AG Vollzeit

    Zur Verstärung unseres Teams suchen wir einen Telcom Sytem Engineer.In dieser abwechslungsreichen Tätigkeit sind Sie in einem aufgestellten Team für die Ausführung und Unterhalt von kompletten Kommunikationsprojekten zuständig.Ihr Aufgabengebiet umfasst die Integration von Alcatel und Aastra IP Telefonanlagen sowie Carrier Services wie Business...

  • Telcom Sytem Engineer

    Vor 5 Tagen

    Bern, Schweiz FOXJOBS AG Vollzeit

    Zur Verstärung unseres Teams suchen wir einen Telcom Sytem Engineer. In dieser abwechslungsreichen Tätigkeit sind Sie in einem aufgestellten Team für die Ausführung und Unterhalt von kompletten Kommunikationsprojekten zuständig.Ihr Aufgabengebiet umfasst die Integration von Alcatel und Aastra IP Telefonanlagen sowie Carrier Services wie Business...

  • Senior Test Automation Engineer

    Vor 6 Tagen

    Bern, Bern, Schweiz TN Switzerland Vollzeit

    Company OverviewTN Switzerland is a leading company in the industry, offering a dynamic work environment and opportunities for growth and development. As a Senior Test Automation Engineer, you will be part of a high-performing Agile team, working closely with developers to enhance our automation testing suite and ensuring the highest quality of our products.

  • Senior Requirements Engineer

    vor 3 Wochen

    Bern, Schweiz TN Switzerland Vollzeit

    Senior Requirements Engineer - Anlagelösung, BernFür unseren Kunden aus der Finanzbranche in Bern, suchen wir eine:n erfahrene:n und aufgeschlossene:n Senior Requirements Engineer - Anlagelösung.Ihre Aufgaben:Analyse der internen und externen (IT-System-) Umgebung im Bereich AnlagelösungenDurchführung von Expertengesprächen, Workshops und Interviews...