Validation Engineer III (site based, Redmond, WA)

Validation Engineer III - Redmond, WA

Just is seeking a highly motivated Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. One of the focuses of this job is to support manufacturing and laboratory equipment, systems, facilities, and utilities commissioning, qualification and validation activities required for clinical and commercial biologics manufacturing as part of a fast-paced and collaborative global validation team. These responsibilities span all phases of the lifecycle from system implementation and qualification to cleaning and shipping validation.

Note: You will be based in our Redmond, WA site, and some travel supporting Seattle, WA site.

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

​The base pay range for this position at commencement of employment isexpected to be$92,400-to $126,500;  Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.