Validation Engineer

GxP Systems, a leader in regulatory compliance consultancy and project management services, enables medical device, biotechnical and pharmaceutical clients to systematically and continuously lower the cost of compliance within their discovery, manufacturing, and supply chain facilities, without compromising compliance or quality.


We are currently looking for a Validation Engineer to join our team. The ideal candidate will have previous experience in a similar validation role in the pharmaceutical or medical device industry.

Responsibilities:

Co-ordination, implementation and active participation in the site validation programme
Develop validation documentation as required (e.g. specifications, plans, protocols, procedures etc.)
Review and approve documents prepared by the validation team and other departments (e.g. commissioning test plans, impact assessments, change controls)
Initiate and implement change control activities in accordance with site procedures
Represent validation department at internal and external audits and support quality assurance programmes
Execute qualification protocols as required and prepare reports
Co-ordinate re-validation activities and generate SOPs / other documentation as applicable
Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements

Qualifications and Experience:

A degree qualification in science or engineering is desirable
Strong knowledge of CSV/GAMP,21CFR Part 11,Project Life Cycle and cGMP Regulations
Ability to apply cGMP regulations and guidelines to all aspects of qualification activities
Strong technical skills
Ability to organize, plan and execute multiple tasks to a schedule
Excellent interpersonal and communication skills
Self starter / takes initiative
Team player
To apply for this role please send your CV to grainne.killilea@gxpsystems.com

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