Engineering - Validation Engineer

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