Validation Engineer

Description

Location: Irvine, CA

Duration: 1+ year contract

Rate: DOE

Start date: ASAP

Essential Job Functions

1. Support production in maintaining validated state of software for controlled manufacturing equipment

2. Validation planning and execution of production control systems

3. Design, generate Test Protocols and Reports

4. Analysis of System and Software Control / Security Requirements

5. Translate process requirements into software requirements

6. Risk Assessment Analysis of production control systems

Marginal Job Functions

7. Provide appropriate input for the Quality System procedures

Nice to have skills

1. Exp. & knowledge in the area of control system, PLC (programmable logic controller), HMI (human machine interface), DCS (distributed control system), databases, FAT (factory acceptance testing), SAT (site acceptance testing), and network qualification

2. Transferring process requirement into SW requirements

a. Generating URS (User Req. Spec.), FRS (Functional Req. Spec.), SDD (SW Design Doc.), System Hazard analysis, and risk assessment.

3. Troubleshot, implement solution

4. Protocol Development

5. Execute and create summary report

6. Able to work flexible hours

Medical device experience preferred, including FDA's 21 CFR CFR Part 11)/ISO 13485 experience

If qualified and interested, please send updated CV in Word format along with best contact times.

To find out more about Real please visit www.realstaffing.com