Description
Major Job Functions:Primary Tasks (list in order of importance)
% of time
Work with cross-function resources to complete User Requirements Specification to prepare for ordering equipment
20
Prepare CPA, order equipment and manage supplier to expected timeline
10
Write and execute IQ/OQ, PQ, TMV and Software validation Protocols and Reports
40
Develop/modify work instruction and/or process sheets required for implementing equipment and submit/manage Engineering Change Request through approval
20
Train maintenance technicians, Engineers, Manufacturing Operators, etc.. about the equipment and process
5
Manage Microsoft project plan for on-time delivery of validation
5
100%
The Validation Engineer will be responsible for purchasing and implementing new equipment or moving and revalidating existing equipment. This includes validation to meet requirements of Medical Device Regulations and Company procedures. Professional technical certification(s) preferred.
A Bachelors of Science in Mechanical, Electrical or Chemical Engineering and 5 to 10 years' experience in specifying, purchasing and implementing equipment with software controls. 10-15 years of technical demonstrated experience for a non-degreed technician may be acceptable. Experience participating in FDA Regulatory audits would be a plus.
The Validation Engineer must have a combination of strong, demonstrated skills including:
- Demonstrated technical capability in the area of specifying, buying and implementing equipment used for manufacturing Medical Devices
- Demonstrated ability to gather customer requirements and write and equipment specification required to purchase equipment
- Demonstrated ability to validate test methods required to validate a process
- Demonstrated ability to write and execute IQ/OQ, PQ, Software Validation and TMV protocols and reports.
- Demonstrated ability to characterize a simple process and identify critical process parameter
- Ability to train junior level resources as it relates to validated equipment
- Interpersonal skills including conflict and relationship management
- Project management skills to effect on-time delivery to a schedule
- Skills to work with cross-function resources to process Engineering Change Requests
- Must be self-motivated with tangible solid contribution, a calculated assertive risk taker and change agent.
To find out more about Real please visit www.realstaffing.com