CQ Fill Finish Engineer
Vor 3 Tagen
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 Client USER - Ops and QA Team.
Main Responsibilities- General Management and Coordination in conjunction with Client and PDP Team :
- 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, Client 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
- 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 relationship 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 Client CTPs, IQ and OQ
- FAT support where requested
- Documented training on PSPs
- CQ Team development and resource and allocation
- Monitoring and coordinate MC readiness
- CQV documentation readiness
- Monitoring and coordinate 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
- 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 Client 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
- 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
- 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
-
CQ Fill Finish Engineer
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Project Delivery Partners VollzeitJob SummaryThe CQ Fill Finish Engineer will be 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 Client USER - Ops and QA Team.Main ResponsibilitiesGeneral...
-
CQ Fill Finish Engineer
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz Project Delivery Partners VollzeitJob Summary:The CQ Fill Finish Engineer will play a crucial role in coordinating CQ activities related to Fill Finish and Process Support Equipment, ensuring adherence to the Baseline Schedule, Functional, Technical, and GDP Compliance, and Start Up safety procedures.Main Responsibilities:General Management and Coordination: Meeting and delivering key...
-
Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Pharmaplan AG Vollzeit{"h1": "Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion", "h2": "Ihre Aufgaben", "p": "Wir suchen einen Pharmatechnik-Experten (m/w/d) für unsere Abteilung Visuelle Inspektion. Als Experte werden Sie verantwortlich sein für die Überprüfung und Erarbeitung des derzeitigen Standards im Bereich automatische, semi-automatische und manuelle Inspektion....
-
Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Pharmaplan AG Vollzeit{"h1": "Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion", "h2": "Ihre Aufgaben", "p": "Wir suchen einen Pharmatechnik-Experten (m/w/d) für unsere Abteilung Visuelle Inspektion. Als Experte werden Sie verantwortlich sein für die Überprüfung und Erarbeitung des derzeitigen Standards im Bereich automatische, semi-automatische und manuelle Inspektion....
-
Basel, Basel-Stadt, Schweiz Pharmaplan AG Vollzeit{"h1": "Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion", "h2": "Ihre Aufgaben", "p": "Als Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion bei Pharmaplan AG werden Sie Teil eines dynamischen Teams, das sich auf die Entwicklung und Implementierung von Inspektionssystemen spezialisiert hat. Ihre Aufgaben umfassen die Überprüfung und Erarbeitung des...
-
Masterand (m/w/d) - Visuelle Inspektion
vor 1 Monat
Basel, Basel-Stadt, Schweiz Pharmaplan AG VollzeitIhre Aufgaben:Als Masterand (m/w/d) im Bereich Visuelle Inspektion werden Sie beauftragt, den aktuellen Standard in der automatischen, semi-automatischen und manuellen Inspektion zu überprüfen und zu erarbeiten. Ziel ist es, diesen Standard mit entsprechenden Anweisungen, Templates und Tools anzupassen. Eine Einbindung unserer globalen COI (Community of...
-
Masterand (m/w/d) - Visuelle Inspektion
vor 4 Wochen
Basel, Basel-Stadt, Schweiz customfield3 VollzeitIhre Aufgaben:Wir suchen einen motivierten und engagierten Masterand (m/w/d) in der Pharmatechnik, der sich auf die Visuelle Inspektion spezialisiert hat. Ihre Aufgaben werden darin bestehen, den aktuellen Standard in der automatischen, semi-automatischen und manuellen Inspektion zu überprüfen und anzupassen. Dabei werden Sie eng mit unserer globalen COI...
-
Associate Director, Drug Product Sales Specialist
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Lonza VollzeitAbout the RoleWe are seeking a highly experienced and skilled Associate Director, Drug Product Sales to join our team at Lonza. As a key member of our sales team, you will be responsible for driving the acquisition of new customers and expanding existing relationships for our Drug Product Services Business Unit.Key ResponsibilitiesDevelop and implement...
-
Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion
vor 3 Wochen
Basel, Basel-Stadt, Schweiz customfield3 Vollzeit{"h2": "Ihre Aufgaben: ", "p": "Wir suchen einen erfahrenen Pharmatechniker, der sich auf die Visuelle Inspektion spezialisiert hat. Ihre Aufgaben umfassen die Überprüfung und Erarbeitung des aktuellen Standards im Bereich automatische, semi-automatische und manuelle Inspektion. Ziel ist es, diesen Standard mit entsprechenden Anweisungen, Templates und...
-
Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion
vor 3 Wochen
Basel, Basel-Stadt, Schweiz customfield3 Vollzeit{"h2": "Ihre Aufgaben: ", "p": "Als Experte für Visuelle Inspektion werden Sie im Rahmen Ihrer Abschlussarbeit den aktuellen Standard im Bereich automatische, semi-automatische und manuelle Inspektion überprüfen und anpassen. Dabei werden Sie gemeinsam mit unserer globalen COI (Community of Interest) Fill and Finish arbeiten, um einen globalen Standard zu...
-
Pharmatechnik-Experte (m/w/d) - Visuelle Inspektion
vor 2 Wochen
Basel, Basel-Stadt, Schweiz customfield3 VollzeitIhre Aufgaben:Als Experte für Visuelle Inspektion werden Sie im Rahmen Ihrer Abschlussarbeit den aktuellen Standard im Bereich automatische, semi-automatische und manuelle Inspektion überprüfen und anpassen. Ziel ist es, die entsprechenden Anweisungen, Templates und Tools zu erstellen und zu implementieren. Eine Einbindung unserer globalen COI (Community...
-
MES Expert with Strong MBR Modeling Skills
vor 1 Monat
Basel, Basel-Stadt, Schweiz ARCONDIS VollzeitKey ResponsibilitiesWe are seeking a highly skilled MES expert with expertise in MBR modeling in PAS-X (Version 3) to drive operational efficiency through effective business process management with our clients.Manage and coordinate projects in Manufacturing of Pharma and/or MedTech clientsDesign and maintain MBRs in PAS-X, preferably Version 3Develop GMBRs...
-
MES Expert
vor 4 Wochen
Basel, Basel-Stadt, Schweiz ARCONDIS VollzeitJob Title: Senior Consultant MES PAS-X MBR DesignerWe are seeking a highly skilled and experienced MES expert to drive operational efficiency and effective business process management in our clients' manufacturing operations.Key Responsibilities:Manage and coordinate projects in Manufacturing of Pharma and/or MedTech clientsDesign and maintain MBRs in PAS-X,...
-
Drug Product Technologies Strategy Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob Description SummaryAs a key member of the Drug Product Development Scientific Office, you will provide strategic and technical guidance on product design and development, driving engagement with industry consortia and health authorities to enable new technologies implementation. You will also propose and drive solutions to development...
-
Drug Product Technologies Strategy Lead
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob Description SummaryAs a key member of the Drug Product Development Scientific Office, you will provide strategic and technical guidance on product design and development, collaborating with stakeholders in CMC to drive engagement with industry consortia and health authorities. Your expertise will be instrumental in implementing new technologies and...
-
Drug Product Technologies Strategy Lead
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob Description SummaryAs part of the Drug Product Development Scientific Office, you will provide strategic and technical guidance on product design and development in liaison with key stakeholders in CMC. You will drive engagement with industry consortia and health authorities to enable new technologies implementation, and propose and drive solutions to...
-
Drug Product Technologies Strategy Lead
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob DescriptionAs a key member of the Drug Product Development Scientific Office, you will provide strategic and technical guidance on product design and development, collaborating with stakeholders in CMC to drive engagement with industry consortia and health authorities. Your expertise will be instrumental in shaping the regulatory environment and...
-
Drug Product Technologies Strategy Lead
vor 1 Woche
Basel, Basel-Stadt, Schweiz Novartis VollzeitJob DescriptionAs a key member of the Drug Product Development Scientific Office, you will provide strategic and technical guidance on product design and development, working closely with stakeholders in CMC to drive engagement with industry consortia and health authorities. Your expertise will be instrumental in shaping the regulatory environment and...
-
HVAC Engineer
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Exyte VollzeitUnlock Your Potential as a Construction Manager at ExyteAre you a motivated and organized individual with a passion for construction management? Do you thrive in a dynamic environment where no two days are the same? We're looking for a skilled Construction Manager to join our team at Exyte, a leading provider of high-tech solutions.About the RoleAs a...
-
HVAC Engineer
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Exyte VollzeitUnlock Your Potential as a Construction Manager at ExyteAre you a motivated and organized individual with a passion for construction management? Do you have a strong background in building services and a desire to work on high-tech projects? If so, we have an exciting opportunity for you to join our team at Exyte as a Construction Manager.About the RoleWe...