Validation Engineer

Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 6 - month contract with potential to extend.
 
100% Onsite
 
 
Responsibilities:
 

• Active participation in the ABB 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 company 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.

 
Requirements:
 

• 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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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.