Validation Engineer Contractor

Team Horizon is seeking a contract Validation Engineer for our clients aseptic manufacturing facility in the Connaught region.

Why you should apply:

• This role will provide you the opportunity to get exposure to a broad range of validation activities on site, and you


• You will be responsible for co-ordinating the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.

What you will be doing:

• Active participation in the Site Validation Program and general Quality Assurance activities.


• Coordination / direction and active participation in the validation and qualification of ABB equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP


• standards.


• Generation/maintenance/execution of Project Validation Plans and schedules.


• Generation of validation protocols and final reports to cGMP standards. QA support for validation investigations and implementation of corrective actions.


• Vendor supervision for execution of validation activities.


• Execution of Autoclave, Parts washer, Lyo, CIP and SIP ,  VHP and Temperature Mapping  to meet initial validation and revalidation requirements.


• Creation/Review/Approval of various validation and qualification documents


• Management of validation, exception event, and change control


• processes.


• Documenting all activities in line with cGMP requirements.


• Performing cross training within the team and training of new team


• members.


• Participation in continuous improvement programs to implement


• improvements in manufacturing, quality, safety and training systems.


• Coordinating activities to maximize the effectiveness of all of the team


• members.


• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

What you need to apply:

• Relevant degree and 5 years’ experience


• Autoclave validation execution experience


• Aseptic processing validation including media fills and VHP validation execution


• HVAC validation