Sr. Equipment Validation SME
Our client is a leading supplier of devices used during critical and intensive care, surgery, post-operative care during recovery, and in a series of high-end, home-infusion therapies. They are in need of a senior level equipment validation consultant to come in and help with validating new equipment.
Principle Duties and Responsibilities:
The consultant will be an equipment validation expert who has been in the medical device industry for 5-7 years. The consultant must be comfortable hitting the ground running, and working independently. The consultant will be working on equipment qualification & validation for a significant amount of new plastics/disposable manufacturing and packaging equipment .
The consultant must be okay with filling in the gaps on templates for the plastics/disposable manufacturing and packaging equipment. The client has some templates, but some have gaps and may need updating or editing. It is key that the consultant can look at older templates and figure out what needs to be changed if anything to get the IQ, OQ and PQ done effectively.
The consultant will be highly proficient in identifying product critical characteristics, and capturing product/process capabilities for Special Purpose Capability Equipment. The consultant must be comfortable with writing & performing plans and protocols for the plastics/disposable manufacturing and packaging equipment. Experience with temperature mapping, HVAC, Thermoformer R425 equipment Validation is preferred.
- 5-7 years Equipment Validation
- 5-7 years Medical Devices
- IQ OQ PQ