Summary
Execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Might provide on shifts support to ensure a reliable machine performance for technical transfer and future site operations.
Lead to setup and coach the maintenance team in the late phase of project execution to ensure adequate resource, technical knowledge and process setup in place to handover the equipment operations related knowledge to production team smoothly.
About the Role
Strategy & Organizational Development
- Support internal and external audits
- Own the Training Curriculum for own Job Profile
- Lead or contribute to equipment, improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance)
- Develop & implement standards.
- Apply the baseline of quality by design, safety by design, radiation protection by design. Apply the mindset of value engineering.
- Form the routine maintenance team for future site routine operations. Train operators and technicians.
- Collaboration with global engineering team and relevant machine vendors. Leverage good practice into Haiyan project.
Maintenance & Calibration
- Get permits for maintenance / calibration / projects
- Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML)
- Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)
Project Engineering & Control
- Develop Project Cost Estimation & Value Improvement Review
- Identify technical solutions
- Prepare project procurement plan, perform project tendering and procurement
- Perform project HSE management & execute project safety stops/reviews
- Perform project reviews (e.g. Technical Quality Review (TQR), constructability)
- Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification)
- Prepare / execute Project Health & Safety Risk Assessments (Equipment / Process)
- Prepare Functional Specifications in project
- Prepare, review and approve drawings, lists, schedules, diagrams, layouts, calculations and datasheets in project
- Issues orders / contracts based on Project Technical Specifications and Bills of Quantities
- Expedite and manage project vendors / contractors / 3rd parties in project
- Develop test specification / plan for commissioning & qualification in projects
- Collaborate with Lean Digital, IT and OT systems into routine machine operations. Collaborate the resource and process during CSV.
- Perform new equipment FAT / SAT / inspections in project
- Perform commission activities
- Manage project deficiencies and deviations
(Re-) Qualification
- Perform GMP risk assessments (incl. Sensors SRA)
- Create DQ, IQ and OQ protocols
- Execute DQ, IQ and OQ
- Create DQ, IQ and OQ reports
- Provide technical trouble shooting during PQ and validation
Knowledge transfer and equipment operations readiness
- Lead to setup and coach the maintenance team in the late phase of project execution to ensure adequate resource, technical knowledge and process setup in place to handover the equipment operations related knowledge to production team smoothly.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
