Senior or Level III Commissioning, Qualification & Validation Engineer

Just is seeking a highly motivated Commissioning, Qualification and 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 validation team. These responsibilities span all phases of the validation lifecycle from system implementation, system qualification, system support and maintenance, to system retirement. Roles Primary Responsibilities: Supporting the generation of key deliverables (in a phase appropriate compliance manner) including system impact assessments, criticality assessments, risk assessments, user requirements specifications, function specifications, and design specifications Lead in the generation, execution, review, and approval of commissioning and qualification protocols for manufacturing equipment, systems, facilities, and utilities Lead in the generation and execution of requirements traceability matrices and qualification summary reports Validation deviation resolution including troubleshooting and root cause analysis Periodic review and requalification of qualified equipment, systems, and utilities to ensure system remains suitable for its intended use and to verify compliance with appropriate industry regulations and company policies Supporting the development of the qualification and validation programs at Just Develop 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 Supporting CQV activities at the Seattle site (early stage clinical) Supporting CQV activities across global expansion sites Education and Qualification Requirements: Bachelor’s degree in engineering science or related program with the following years in relevant experience: For CQV Engineer III - 5 years For Sr CQV Engineer - 7 years 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 with quality risk management Experience authoring, reviewing, and approving validation documentation Knowledge of process equipment, utilities, operations, and engineering principles Must possess strong focus on quality and attention to detail Must possess problem-solving and critical thinking skills Motivated, self-starter with strong mechanical aptitude Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment Excellent interpersonal, team, and communication skills are a must High level oral and written communication skills are a must Possess effective task/time management organizational skills Additional Qualifications: Strong understanding of process automation (e.g. DeltaV) Previous work 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 Working knowledge of Computer Systems Validation Working knowledge of Quality Control equipment and systems Experience performing swab and rinse sample collection Experience with soils analysis, detergent analysis, and MACO (Maximum Allowable Carry Over) calculations The base pay range for this position at commencement of employment is expected to be $90,000 to $150,000; 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 and 401k company match, flexible 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. Evotec is a life science company with a unique business model focused on delivering highly effective new therapeutics to the patients. The Company leverages its multimodality platform, the “Data-driven R&D Autobahn to Cures”, for proprietary projects and within a network of partners including Pharma, Biotech, academics, and other healthcare stakeholders. With more than 4,500 highly qualified people at 17 sites, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics. For additional information please go to www.evotec.com and follow us on Twitter @Evotec and LinkedIn. Please click on the link below to access and review our Privacy Information for Applicants: Privacy Information for Applicants

Salary : $90,000 - $150,000