Sr Validation Engineer - Analytical Equipment

_____________________________________________________________________________Just is seeking a highly motivated Analytical Equipment Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this role is to support Commissioning, Qualification and Validation (CQV) facility start up activities including Analytical Equipment. These responsibilities span all phases of the validation lifecycle from system implementation, system qualification, system support and maintenance, to system retirement.

Roles Primary Responsibilities:

• Support the generation and/or review of key deliverables including User Requirements Specifications, System Impact Assessments, Criticality Assessments, Data Integrity Assessments, Design Qualification, Requirements Traceability Matrices, Commissioning, IQ, OQ and PQ protocols for Analytical Equipment
• Collaborate with multi-disciplinary team : external partners, consultants, Quality Control, Manufacturing, Process Engineers, E&HS, Quality
• Assure that the schedule of generation of CQV documentation is on track
• Support the execution of the CQV activities including commissioning, IQ, OQ and PQ
• Contribute to Validation deviation resolution including troubleshooting and root cause analysis
• Perform 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
• Support the development of the qualification and validation programs at Just
• Develop phase appropriate ways to comply with regulatory requirements
• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
• Support implementation of CMMS (Computerized Maintenance Management System)
• Support Document Control Management activities (electronic storage architecture, levels of rights…)

Position Requirements:

• Master degree in engineering science or related program with 8+ years of relevant experience in that field and GMP environment
• Understanding of industry standards and best practices for a science and risk-based approach to qualification of analytical equipment
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations
• Familiarity with European, US, Japanese Pharmacopeia regulations related to Analytical Equipment Qualification
• Experience authoring and reviewing validation documentation
• Experience with quality risk management
• Knowledge of analytical equipment 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
• Possess effective task/time management organizational skills
• Possess strong analyze and synthesis skills
• Ability to adapt to a working environment where all the SMEs and the team members are not onboarded yet and the Quality System is being established at the moment
• Verbal and written communications skills in both English and French

Additional Preferred Qualifications:

• Knowledge of Paperless Validation Software (e.g. Kneat)
• 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 Qualification of Manufacturing equipment

About Just – Evotec Biologics

Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are currently co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 300 employees is expanding Just's innovative platform and footprint - Opening our first North American J.POD® commercial manufacturing facility in the Seattle area and building our second European J.POD commercial manufacturing facility in the Toulouse France are. For job opportunities, learn more at www.just.bio/careers.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.