Job Title: Validation Engineer
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We are seeking a skilled Validation Engineer to join our team in County Sligo, Ireland. This is a 6-month contract opportunity.
Located on the picturesque west coast of Ireland, our state-of-the-art pharmaceutical facility is looking for a Validation Engineer to lead our site equipment, facilities, utilities, processes and software validation efforts in compliance with company policies, FDA, European cGMP and GAMP standards.
Responsibilities:
* Ensure all Computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
* Coordinate direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
* Generate and maintain Validation Master Plans.
* Generate and maintain Project Validation Plans.
* Generate validation plans, protocols and final reports to cGMP standard.
* Review and approve all protocols and final reports.
* Manage validation change control process.
* Adhere to and support all EHS & E standards, procedures and policies.
Requirements:
* Third-level qualification in a relevant engineering or scientific discipline.
* A minimum of 5-10 years' experience in a cGMP regulated environment.
* A good understanding of regulatory requirements.
* Requires a high level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures at all times.
* Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
* Requires innovative thinking where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
If you meet the above requirements and have a passion for quality and compliance, please submit your application.