Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
Engineering Project Support and Operation Readiness:
- Act as the Automation representative on the project team, contributing to design, construction, and qualification activities. This includes reviewing URS (User Requirement Specification) and executing FAT and SAT to contribute to project delivery.
- Lead or act as the automation maintenance team coordinate with Engineering department, production department, quality department, vendors, etc. for cooperation to achieve the positive goal.
- Establish and develop the automation system in alignment with the Roche standards including maintenance management system, people training and qualification, CCS strategy and implementation to support robust operation readiness.
- Support manager to develop a competent team through coaching, mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities.
- Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing.
- Represents the automation during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.
Routine Operation& Maintenance:
- Implementations Support
- Improve management of, and access to, business-critical scientific data for all scientific disciplines across Roche.
- Provide consultation with regards to automation systems, computerized systems and software, implementation and validation.
- Business Partnering and Solution Provision
- Strive to provide the best workable solution using the software/systems and systems available in alignment with the sites digital strategy.
- Develop an in-depth understanding of Automation/IT and business initiatives, strategies and needs for the future and ensure alignment of Automation/OT strategy.
- Be aware of current and emerging technologies which could benefit/add value to the site and promote these opportunities internally.
- Provide strategic directions to the automation group specifically around the areas of software and hardware. Responsible for implementing site digital roadmap according to Roche global strategy.
- Automation Operations
- Provide SME support to manufacturing and other departments for the design and operation of process automation equipment.
- Conduct troubleshooting and technical analyses on manufacturing equipment and process automation system including PI data analyses, code review/troubleshooting, etc.
- Act as controls engineer for tech transfer or new process into the facilities.
- Support production and project teams in all questions of Automation and controls
- Develop technical knowledge on manufacturing equipment and process automation system.
- Secures professional and economic execution of all activities and high availability of manufacturing unit and equipment.
- Also provide training to site users to ensure the operational use, and shop floor service during production.
- Create/Revise/Review Automation and manufacturing related SOP's Functional Specs, work instructions, equipment and process changes.
- Perform high level system administration of Automation systems: managing the user roles, including their configurations, security rights and access rights.
- On call for system emergent complex trouble shooting escalated from technicians.
- Ensure that all relevant information relating to activities within your scope are tracked, captured and forwarded in due time to your manager or the head of department
- Compliance:
- Ensure audit readiness by adhering to GMP, regulatory, and statutory requirements to protect product quality and prevent compliance observations.
- Troubleshooting& Improvement:
- Respond to critical alarms and provide timely technical support for complex issues.
- Drive continuous improvement initiatives to enhance sustainability, safety, and asset reliability.
- Ensure in time response to critical alarms in compliance with the SOP and related procedures.
- Evaluate the alarm trends and establish corrective actions to avoid repeat events.
- Assets Lifecycle Management& Reliability
- Evaluate the system capacity and provide related Operational& Maintenance data for project initiation.
- As the automation system owner and SME, actively participate in the design, review, comment, commissioning and handover of site new projects according to Site CAPEX process.
- Responsible for the implementation of the site Reliability Engineering process within owned areas.
- Establish and maintain a strategic and technical roadmap for the responsible area to support the site's strategic development and product lifecycle.
Qualification and Experience
Education/Qualifications
- Bachelor’s degree or above in Automation or a related field.
Job Required Competencies
- Experience: Minimum of 8 years of electrical management or engineering experience in injection pharmaceutical industry, MNC Bio-pharma preferred.
- Expertise:
- Experience with MES/PI/LIMS/EMS/BAS/SCADA/PLC and related software.
- Familiar with Visualization Platform.
- Expertise on data integrity.
- General knowledge of network, cyber security, firewalls, operation system,
- Startup Experience: Experienced in new facility startup readiness and operation ramp-up.
- Communication: Fluent in written and spoken English, with strong collaboration skills to effectively work with diverse teams and stakeholders.
- Strategy Thinking: Able to think strategically and translate strategies into actionable plans, understand and apply agile ways of working
Preferred Qualifications (Nice to Have)
- Experience with Lean Manufacturing or Six Sigma methodologies.
- PMP or other project management certifications.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
