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
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