Senior Reliability & CAPEX Engineer

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The Position

Roche is hiring for a greenfield facility in Shanghai and we are looking for a skilled Reliability & Capex Engineer. The Reliability & Capex Engineer has overall accountability for the asset life-cycle management for all site equipment facilities and utility systems including local CAPEX project management and asset reliability programs.

Strong skill and experience are required to cover two areas: Greenfield project delivery and Routine Operation.

Demonstrate leadership behavior and mindset.

The role plays a critical part in strategic project realization including all facilities/utilities/equipment reliability design qualification and operation readiness and start up.

This role will ensure close collaboration with the site and project organization to ensure Roche business goals responsible for the following activities:

1) Asset Life Cycle Management Process to build up and follow global standards.

2) Reliability Process to build up and follow global standards.

3) Maintenance and Calibration Process to build up and follow global standards.

4) CMMS/CCS (Computerized Maintenance Management System/ Computerized Calibration System) to build up and follow global standards.

CAPEX portfolio/project governance/management process build up and follow global standards.

Principle Roles & Responsibilities / Accountabilities

Engineering Project Support and Operation Readiness:

Reliability

• SAP Plant Maintenance Governance: Serve as the strategic owner for calibrations maintenance & spare parts platforms to make sure the SAP functions during the project phase can sustainably meet the operational requirements.

• Digitalization Ambassador: Drive the leverage of system data for high-level decision-making performance benchmarking and harmonizing site practices with global digital protocols.

Work with global project team and cross functional teams to implement and deploy the digital Asset Management systems (calibration maintenance and spare parts) on time and on budget.

Establish and develop digitalization programs and process to support site asset lifecycle management aiming to improve site efficiency reduce cost and improve collaboration in meanwhile collaborate with global team to assess and implement up-to-date technology to local site

• Digitalization Ambassador: Drive the leverage of system data for high-level decision-making performance benchmarking and harmonizing site practices with global digital protocols.

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.

• Digitalization Ambassador: Drive the leverage of system data for high-level decision-making performance benchmarking and harmonizing site practices with global digital protocols.

Lead or act as a reliability team coordinate with the Engineering department production department quality department vendors etc. for cooperation to achieve the positive goal.

Establish and develop reliability operation system in alignment with the Roche standards including maintenance management system people training and qualification CCS strategy and implementation to support robust operation readiness.

Represents reliability during regulatory inspections and audits and participates in the response of regulator audit and global quality audit.

Participate in tech transfer collaboration with other functions to ensure the success of new product manufacturing.

Routine Operation & Maintenance:

Reliability

Boost the plant performance: Continuously improve the reliability of the facility and equipment through up-to-date tools and platforms by collecting meaningful data from the facility and equipment with other functions like F&U automation and manufacturing functions.

Deploying the reliability culture into an asset strategy that considers maintenance operations spare parts asset replacement and reinvestment.

Establish and optimize preventive and corrective maintenance strategies and translate specific maintenance plans for all site assets that maximize equipment availability and optimize life-cycle costs.

Guide the internal team to ensure that the maintenance/calibration work is completed in compliance with established processes and standards.

End to End asset lifecycle management: Set up and implement the maintain plant business process asset life-cycle management including asset criticality conditions assessment and applicable risk assessments.

As a factory representative understand the groups strategies/initiates related to the Assets life cycle and implement them locally.

Continuous improvement in the stie Asset Life Cycle Management process to drive the assets configuration align with site development strategy and product life cycle.

SAP Master: act as the expert of SAP plan maintenance module to centralize any maintenance & calibration systems operation and problem solving including master data maintenance. Join the network committee for continuous improvement if necessary

Represent the SAP Manit Plant process during regulatory inspections and audits.

Spare parts Engine: centralized management of site spart parts to ensure clear inventory and critical spare parts are in place to reduce the business interruption risk. This will include management of the physical warehouse SAP EWM module 3rd party employee management.

Establish and maintain a strategic and technical roadmap for the responsible area to support the sites strategic development and product lifecycle.

CAPEX Projects Governance & Execution

Center of CAPEX management: Co-lead with manager to set up a LEAN site end to end CAPEX / portfolio management process to ensure site portfolio process can serve as the strategic guidance for right capital investments and ensure projects priorities are aligning with site strategic roadmap.

Site CAPEX project execution ensure project follow GEP and global standard ensure the project delivery with pre-defined KPIs (Scope time quality budget).

Supporting the site annual CAPEX plan aligns with site strategies. Specifically the annual capital planning process drives consistent prioritization cash flow reporting and establishes KPIs that ensure adherence to the annual capital plan and individual project commitments.

Ensure SHE and cGMP Compliance for all Engineering functions.

Continuous improvement in the stie CAPEX Management process to build an efficiency and compliance way of project execution.

Qualification and Experience

Education/Qualifications

Bachelors degree or above in Engineering (Mechanical Electrical Industrial Materials Science) or a related field.

PMP is a must.

Job Required Competencies

8 or more years plant maintenance reliability engineering or related experience in the injection pharmaceutical industry MNC Bio-pharma preferred.

5 or more years project management experience in the injection pharmaceutical industry MNC Bio-pharma preferred.

Expertise knowledge and experience on FEMA RCA PM CM PdM CdM.

Experienced in strategic project of Aseptic Filling facility including design commissioning & qualification.

Experienced in new facility startup readiness and operation ramp up including organization people and operation management system.

Experienced in SAP Plant Maintenance module design and deployment

Able to think strategically and translate strategies into actionable plans understands and applies agile ways of working.

Fluent communications skills in English and the ability to effectively communicate collaborate and foster positive interactions with team members and stakeholders.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.