Validation Engineer

Location: Belfast  |  County Antrim  |  Northern Ireland
Sector: Life Sciences
Consultant: Chris Kerr
Job Reference: CK/HQ279
Salary: £27000 - £32000
Job Status: Permanent / Full Time

JOB TITLE            Validation Engineer

 

REPORTS TO       Design Quality Engineering Manager    

 

POSITION SUMMARY    

Responsible for supporting process, product and supplier validation activities, including protocol drafting, execution and report creation for a class III medical device.

KEY AREAS OF RESPONSIBILITY  

The Validation Engineer will be responsible for the following activities:

1.            Understanding the relevant process, product or supplier part requiring validation support

2.            Interpretation of requirement specifications

3.            Drafting validation protocols

4.            Execution of validation activities

5.            Drafting validation reports

6.            Updating validation protocols and reports as needed

7.            Support the provision of project activities and timelines to the project manager as needed

8.            Support risk management activities as required

QUALIFICATIONS KNOWLEDGE SKILLS    

•             Qualifications:

2:1 in Engineering or Science or an equivalent qualification

•             Experience:

Minimum of 2 years’ experience in a regulated industry 

•            Specific Knowledge

An understanding of ISO 13485: 2016

Knowledge of 21 CFR part 820

Knowledge of ISO 14971 and ISO 14155 would be advantageous

•             System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

•        Key Competencies needed for this position?

Attention to Detail

Good time management skills

      Effective Communication Skills

      Highly developed technical writing skills