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:
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)