Recipe Driven Execution Systems Lead

Vor 2 Tagen

Bern, Schweiz CSL Behring Vollzeit

**Responsibilities**:

- Act as a Change Agent for the respective site, representing Execution Systems RDE to all site stakeholders, including Quality, Manufacturing, Process Engineering, Facilities, and EHS&S. This will include building strong relationships with the customer base and helping them set the proper expectations for project delivery.
- Responsible for interfacing with the user community (Process Engineering, Manufacturing, Quality Operations, etc.) to support RDE implementation both prior to project initiation as well as RDE lifecycle. Support includes training of value drivers, integration into design, start-up support, and support from a data analytics perspective utilizing OSI Pi. Ensures that the end user community at the site understand the capabilities and value in the RDE implementation, and collaborates with them to maximize the value from RDE.
- Primary ES Point of Contact for the site stakeholders related to RDE project(s) roadmap, design, configuration, implementation, and qualification.
- Ensures adherence to the global strategy & scope by providing technical direction and support for the design, implementation, and lifecycle management of PCS, MES, PLC and Data systems for RDE implementation projects.
- Interfaces with customer groups on the project to ensure we are designing, executing, and delivering in accordance with Global Engineering procedures and Execution Systems standards.
- Ensures the overall RDE design and implementation for site CAPEX projects meet Engineering, Manufacturing, and Quality requirements and standards for the operation of the plant. Ensures the standards and templates are being used and understood by the site ES team.
- Accountable for site alignment with Global RDE design standards via interfaces with the Standards and Governance lead, and guidance for the RDE project leads at the respective site. Ensures adherence to CSL’s S88/S95 standard during the lifecycle of RDE projects.
- Accountable of CAPEX project design phase to be fully in compliance with the RDE philosophy goals and objectives
- Supports the technical RDE implementation and technical governance to align on and approve global design changes and standards. Interfaces with the global Standards and Governance lead on the process to evaluate and document any changes to existing standards.
- Contributes to the external partner governance of the RDE global library object standards via Library as a Service (LaaS)
- Supports and guides the team responsible for writing and reviewing RDE Execution System documentation as required by projects and ongoing operations.
- Participates in the creation of the Execution System validation strategy together with the Global and Site CSV & Quality representatives.
- Documents and shares knowledge with other site RDE Implementation Leads to enable continuous improvement via global technical governance committee inclusive of engagement with Execution Systems external partners. Seeks opportunities for optimization of the design, implementation, and qualification activities within the Execution System scope.
- Responsible for ensuring understanding of the current Manufacturing processes within the value stream, working in collaboration with the value stream network.
- Responsible for RDE continuous improvement via tracking of past project success and lessons learned to improve future project implementations.

Qualifications:

- Bachelor of Science (or equivalent) in a relevant Engineering or Science discipline. Masters preferred
- Minimum of 5 years' practical leadership experience in the pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems/Automation; 8 years preferred, with 5 years or more working experience in Execution Systems/Automation design and support
- Considerable knowledge of pharmaceutical (drug substance and drug product)
- manufacturing operations and support functions, including Quality and Process Engineering.
- Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95).
- Direct experience designing, building, deploying and supporting automation and execution systems in a regulated large-scale process-based manufacturing environment.
- Experience in running site-based shop floor systems in a globally distributed footprint is highly desirable.
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.
- Ability to build, mentor and grow a high performing and cohesive team.
- Experience in Process Excellence methodology is desirable, but not required.
- Must have demonstrated capability for technical leadership in complex DCS/PCS /Automation projects with integrated MES systems, initial development through validation of the facility
- Must have demonstrated experience in collaborating with site Manufacturing, Quality and Process Engineering personnel in the impl

  • Regional Value Stream Recipe Owner Fill Finish

    Vor 2 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    **Responsibilities**: - Adherence to the global strategy & scope by maintaining/delivering/implementing the required process control within the DCS, PCS, MES and PLC systems for both new and legacy systems. - Alignment of the system with the Global Execution Systems approach within Manufacturing Operations. - Technical project ownership for all Execution...

  • Cq Execution Lead

    vor 7 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    CQ Execution Lead **Job Description**: **Job Summary** The CQ Execution Lead is responsible for supporting the planning, execution and supervision of the entire Project Commissioning and Qualification field activities. To support meeting the agreed objectives regarding schedule and functionality according to URS, GMP, Safety and environmental...

  • Cq Execution Lead

    vor 7 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    **Job Summary** The CQ Execution Lead is responsible for supporting the planning, execution and supervision of the entire Project Commissioning and Qualification field activities. To support meeting the agreed objectives regarding schedule and functionality according to URS, GMP, Safety and environmental objectives. **Main responsibilities** Main...

  • Analytical Execution Team Lead

    vor 19 Stunden

    Bern, Schweiz CSL Behring Vollzeit

    **The Opportunity**: We are looking for an Analytical Execution Lead for the newly formed Analytical Strategy Team. The Analytical Strategy team is responsible for aligning the analytical strategy across projects, supporting the overall analytical strategy, playing an essential role in product development. As Analytical Execution Lead, you coordinate all...

  • Head of Lab Execution Systems, Senior Director

    vor 2 Monaten

    Bern, Schweiz CSL Plasma Vollzeit

    The OpportunityThe Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also...

  • Laboratory Execution Systems

    Vor 2 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Join Our On-Site Team in Bern, Switzerland as a: Laboratory Execution Systems - IT Lab Support Analyst (m/w/d) As a Laboratory Execution Systems - IT Lab Support Analyst, you will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory...

  • Laboratory Execution Systems

    Vor 4 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Join Our On-Site Team in Bern, Switzerland as a: Laboratory Execution Systems - IT Lab Support Analyst (m/w/d) As a Laboratory Execution Systems - IT Lab Support Analyst, you will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory...

  • Laboratory Execution Systems

    vor 2 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Join Our On-Site Team in Bern, Switzerland as a: Laboratory Execution Systems - IT Lab Support Analyst (m/w/d) As a Laboratory Execution Systems - IT Lab Support Analyst, you will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory...

  • Laboratory Execution Systems

    vor 4 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Join Our On-Site Team in Bern, Switzerland as a: Laboratory Execution Systems - IT Lab Support Analyst (m/w/d)As a Laboratory Execution Systems - IT Lab Support Analyst, you will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory...

  • Laboratory Execution Systems

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Join Our On-Site Team in Bern, Switzerland as a: Laboratory Execution Systems - IT Lab Support Analyst (m/w/d)As a Laboratory Execution Systems - IT Lab Support Analyst, you will be responsible for maintaining and supporting the Quality Control (QC) computerized laboratory...

  • Lead Cqv Consultant

    vor 3 Monaten

    Bern, Schweiz Consultys Vollzeit

    Missions As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks include but are not limited to: Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans. Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors...

  • Lead CQV Consultant

    vor 3 Monaten

    Bern, Schweiz Consultys Vollzeit

    MissionsAs part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks include but are not limited to:Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans.Lead and coordinate the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and...

  • Cqv Leads

    vor 8 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    Job Summary PDP is a number one CQV Project Partner in Switzerland. We have ongoing requirements in Switzerland, and other European locations. We are actively interviewing CQV Leads who have strong knowledge and experience of Upstream / Downstream / Clean /Black Utilities / Support Services Commissioning and Qualification. The CQV lead(s) will proactively...

  • Cqv Lead

    vor 7 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    **Job Summary**: The CQ Lead is responsible for planning, preparation, coordination and leading a CQ team from documentation preparation through FAT, CM oversight, MC, integrated CQ execution and successful handover to the Client USER team. The scope of CQV activities relates to Facility, Utilities, Process and Process Support Equipment. Aside to delivering...

  • Leader, QA Engineering

    vor 5 Monaten

    Bern, Schweiz Cisco Systems Vollzeit

    Isovalent, now part of Cisco, is the company founded by the creators of Cilium and eBPF. Cisco Isovalent builds open-source software and enterprise solutions solving networking, security, and observability needs for modern cloud-native infrastructure. The flagship technology, Cilium, is the choice of numerous, industry-leading, global organizations. We...

  • Clean Utilities Lead

    vor 7 Monaten

    Bern, Schweiz Project Delivery Partners Vollzeit

    Clean Utilities Lead **Job Description**: **Job Summary** The function will be to plan, supervise and manage all works associated with all Clean Utility CQV documentation, walkdown, commissioning and qualification of the following systems: - Clean Utilities: - WFI Generation Systems - WFI Storage Tanks - WFI Distribution - Clean Steam Generators - Clean...

  • Computer System Validation

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Position Purpose**: The Computer System Validation Specialist will be responsible for executing the Computerized System Validation (CSV) deliverables for control systems within Execution Systems (ES) and interfaces. Responsible for the implementation of Execution Systems projects and programs at their respective site. Maintain the validated status of ES...

  • Manager 2 Pharma Quality Systems Capa

    Vor 2 Tagen

    Bern, Schweiz Johnson & Johnson Vollzeit

    Janssen Supply Group L.L.C. is recruiting for a Sr. Manager, Quality Systems CAPA, This position has a primary location of Titusville, NJ. It can also be based in Bern, Switzerland; Schaffhausen, Switzerland; Beerse, Belgium; Latina, Italy; Cork Ireland; Leiden Netherlands; Raritan, NJ or Gurabo, Puerto Rico. Outside of the United States, other consideration...

  • Manager 2 Pharma Quality Systems Capa

    Vor 2 Tagen

    Bern, Schweiz Johnson & Johnson Vollzeit

    Janssen Supply Group L.L.C. is recruiting for a Sr. Manager, Quality Systems CAPA, This position has a primary location of Titusville, NJ. It can also be based in Bern, Switzerland; Schaffhausen, Switzerland; Beerse, Belgium; Latina, Italy; Cork Ireland; Leiden Netherlands; Raritan, NJ or Gurabo, Puerto Rico. Outside of the United States, other consideration...

  • Global Esi Analytical Services Lead

    vor 2 Wochen

    Bern, Schweiz CSL Behring Vollzeit

    **Position Purpose**: The Analytical Services External Supply Integration (ESI) Global Lead is responsible to develop a Global Analytical Partnering Strategy in close collaboration with the leadership of Quality Control and Research and Development. The role will execute a significant portfolio of technology transfers and establish a stable and reliable...