Validation Engineer - Digital Systems - Toulouse, France

Just is seeking a highly motivated Senior Digital Systems Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this role is to support Computerized System Validation (CSV) start up activities including Computer Systems of Manufacturing equipment, Facilities, and Utilities, Analytical Equipment and Systems. 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, Data Integrity Assessments, Master Data Mapping, Validation Plans, Design / Configuration / Functional Specifications, Code Review, Design Review / Qualification, Requirements Traceability Matrices, FAT, SAT, Commissioning, IQ, OQ, PQ protocols, Operational / Maintenance SOPs, System Administration SOPs, Validation Summaries for IT infrastructure, Computer Systems of manufacturing equipment, facilities, and utilities, analytical equipment and systems
• Collaborate with multi-disciplinary team : external partners, consultants, Facilities and Engineering, Process Engineers, Automation, Quality Control Labs, E&HS, Quality
• Assure that the schedule of generation of CSV documentation is on track
• Support the execution of the CSV activities including FAT, SAT, commissioning, IQ, OQ and PQ
• Contribute to Validation deviation resolution including troubleshooting and root cause analysis
• Perform Periodic Review and Requalification of qualified systems 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 this field in a gmp environment
• Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and facilities
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations, GAMP 5, 21 CFR Part 11, EU GMP Annex 11
• Experience authoring and reviewing, validation documentation
• Experience with quality risk management
• Knowledge of Paperless Validation Software (e.g. Kneat)
• Strong understanding of process automation (e.g. DeltaV)
• Previous work experience with Quality Building Management Systems (QBMS) and MES
• Knowledge of computerized systems 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:

• Applies knowledge and expertise to solve complex technical problems
• Significant contributor to multi-disciplinary teams at the functional level
• Working knowledge of Commissioning Qualification Validation of Manufacturing, Facilities and Utilities, Analytical 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

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.