Validation Engineer - Medical Device

Validation Engineer - Medical Device

DPS currently require a Validation Engineer for a Dublin based Medical Device organization.

Category:
Validation
Location:
Leinster
Years of Experience Req.:
3years+
Date Posted:
15/12/2021
Days Remaining:
63
Employment Type:
Contract
Education Level Req.:
Degree

Validation Engineer                                             

DPS currently require a Validation Engineer for a Dublin based Medical Device organiz172368.264707ation.

Responsibilities:

Work with validation team to ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements

Support site and corporate change control procedures.

Draft URS, SRS, FDS and associated trace matrices across a range of automated process equipment

Assist with Process Development, conduct DOE and MSA.

Define validation sampling and inspection plans based on Risk Assessment

Draft and execute IQ, Process Development, OQ and PQ on new/revised processes

Develop and execute software test cases to support changes as necessary.

Create and control PFMEA, control plans and Risk Management documentation through product life cycle.

Publish site specific progress reports as required.

Update documentation via documentation control system, SAP.

Link with Post Validation activities including closure of change control

 Education/Training/Experience:

Third level qualification in relevant area of Engineering / Quality or Manufacturing

4years+ of experience in validation or qualification in healthcare or other regulated field.

Excellent and technical writing skills.

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