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