Validation Engineer - Contractor

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.

What you will be doing:

• 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

What you need to apply:

• 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.