Preffered Knowledge:
- Appropriate safety precautions, procedures, practices and regulations
- External Standards including; ISO10012, ISO 13485, ISO17025 and others
- Installation, repair and maintenance of a wide range of mechanical, electrical, electro mechanical and electronic equipment
- Mathematical principles applicable to the electrical and electronic trades
- Metrological theories, principles and practices including theoretical physic
Education and Experience:
- Equipment life cycle management and project management skills required.
- Requires a minimum of an Associate’s degree with a scientific or Electronics Engineering focus or comparable degree
- Calibration, maintenance and repair training, preferably in a bioscience, pharmaceutical, utility, industrial, manufacturing operation
- Training specialized in electronics, instrumentation, calibration, computer theor
Responsiblities
- Equipment life cycle management and project management skills required.
- Work with European suppliers and accommodate European time zone.
- Lead and participate in meetings with European suppliers and European Global Procurement to answer questions and coordinate work.
- Coordinate with internal dual-site ROUGE Project team (equipment owners) to obtain answers/questions on equipment, accessories, and technical questions.
- Equipment technical knowledge and calibration knowledge preferred.
- RFQ Global Procurement Process Selection of Supplier/Equipment
- Work with Procurement to evaluate multiple vendors and select equipment and supplier to obtain final quotes.
- Maintain file of equipment information and identify other equipment accessories such as IQOQ, rotor, adaptors, etc.
- Coordinate answers to vendor equipment questions
- Research alternative models; work with team to select or reject alternative models
- Communicate decision to accept/reject alternative models, or propose another model
- Evaluate services provided such as storage, delivery time, unpacking, installation schedule, etc.
- Organize and maintain information in an effective manner to allow the purchase requisition to be easily created
- Equipment Acknowledgment of Receipt – Coordinate off-site equipment schedule for delivery, unpacking, and calibration schedule/timeline.
- Ensure vendor or responsible party performs additional services of equipment: delivery, unpacking, installation
- Coordinate structure and timeline of equipment expectations with Supplier and Process Owner
- Create system to track receipt of Equipment and confirm completion of check-in process RFQ Global Procurement Process for Selection of Service Providers
- Work with Procurement to identify service providers. Identify and resolve needed modifications to system.
- Evaluate multiple service providers and answer technical equipment questions
- Prepare and maintain list of final equipment model (accepted alternative models from Supplier) Installation Services:
- Identify equipment requiring Installation Services
- Determine if selected Supplier can provide Installation Services Calibration Services:
- Identify/review if equipment requires calibration and specifications (from ISR)
- Evaluate and work with Supplier to meet internal calibration specifications
- Determine Supplier calibration specification details for new models and evaluate if business accepts Equipment Approval Testing:
- Identify/review the need for Equipment Approval Testing forms, and if existing, summarize info for Supplier’s review
- Work with Instrumentation to respond to Equipment Approval Testing questions
- Equipment Qualification at Start Up – Work with Vendor/QA/Process Leads to schedule and complete equipment Calibration / Validation / Verification.
- Meet regularly with QA/Instrumentation on Equipment Plan
- Work with Vendor to schedule date for vendor to start and complete Calibration
- Work with QE/Instrumentation/Process Lead for ISR documentation revision for new models or changes to call
- Maintain list of all services contracted for all equipment
- Organize timeline of service for all equipment
- Ensure correct forms and services (calibration, validation, verification, testing) are being provided within scope of agreement.
- Manages/directs Life Cycle System maintenance and compliance
- Oversees the timely generation, maintenance and reporting of the required department metrics and all work performed as measured against (SLA Metrics, Local Metrics & Corporate Metrics)