Validation Engineer
Company
Orion Group
Employment type
Full-time
Posted
3 days ago
Listed via
Orion Group
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
People
are our business
worldwide
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.
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