What are the responsibilities and job description for the Engineering - Validation Engineer position at Futran Tech Solutions Pvt. Ltd.?
Job Title : Validation Engineer
Location : Seattle, WA - Onsite
Responsibilities :
Lead the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC / Analytical, Cleaning and Shipping
Support development of robust collaboration for CSV and Process Validations
Support the development of the qualification and validation programs at Just including the transition from paper based to digital validation software to configure globally scalable end to end paperless solutions to manage the validation lifecycle
Develop and strategize compliant and novel ways to comply with regulatory requirements
Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
Lead CQV activities across global expansion sites
Education and Qualification Requirements :
Bachelor's degree in engineering science or related program with at least 7 years in relevant experience
Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and / or facilities
Working knowledge of US FDA CFRs and European EMA, including ICH regulations
Experience authoring, reviewing, and approving validation documentation
High level oral and written communication skills are a must
Additional Qualifications :
Understanding of process automation (e.g. DeltaV) with previous experience with Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus
Applies knowledge and expertise to solve complex technical problems
Significant contributor to multi-disciplinary teams at the functional level
Led a team or large validation projects
Direct working knowledge of utilities, facilities, computerized system, and analytical equipment
Working knowledge of shipping, transport logistics, cleaning validation methodologies and process validation
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