Overview
Team Horizon is seeking a Validation Engineer for our Clients manufacturing facility in Connaught on a 6-month initial contract.
You will coordinate, implement, and actively contribute to the site's Validation Program—ensuring full compliance with regulatory, data integrity, and company requirements.
Why you should apply
This is a high-impact role with autonomy and visibility across multiple functions.
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 cGMP 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 cGMP standard.
Understanding of Risk based equipment qualification, Equipment Risk Assessments, Critical Elements Test Plan development.
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.
Qualifications
A minimum of 5-10 years' experience in a cGMP regulated environment.
A good understanding of regulatory requirements.
Must have hands on experience of execution of IQ/OQ/PQ for Facilities/ Utilities/ Equipment in Pharmaceuticals or Medical Devices or Diagnostics
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.
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.
Demonstrates the highest levels of integrity and a strong work ethic at all times.
Strong communication skills both verbal and written are required for the execution of this role.
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