Validation Engineer

September 13, 2024

GerTEK Project Management and Technical Services

FULL TIME

Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below:
We are hiring Validation Engineer's for the Sligo region.
Will coordinate the development and maintenance of the company’s validation program in
compliance with all applicable regulatory and company requirements.
Co-ordination, implementation and active participation in the site Validation Program.
Job Responsibilities:

Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European c GMP and GAMP standards.
Generation/maintenance of the Validation Master Plans.
Generation/maintenance of Project Validation Plans.
Generation of validation plans, protocols and final reports to c GMP standard.
Review / approval of all protocols and final reports.
Management of validation change control process.
Adheres to and supports all EHS & E standards, procedures and policies

Education

3rd level qualification in a relevant engineering or scientific discipline.

Key Skills

A minimum of 5-10 years’ experience in a c GMP regulated environment.
A good understanding of regulatory requirements.
Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
Requires total commitment to quality and maintaining a high standard of work at all times.

We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Validation Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.
Job Type: Full-time
Schedule: