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Senior Validation Engineer
Il y a 2 mois
We are seeking a highly motivated Senior Digital Systems Validation Engineer to join our team at Just - Evotec Biologics. As a key member of our team, you will play a critical role in supporting the validation of computerized systems, manufacturing equipment, facilities, and utilities, as well as analytical equipment and systems.
Key Responsibilities:- Support the generation and 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
- Collaborate with multi-disciplinary teams, including external partners, consultants, Facilities and Engineering, Process Engineers, Automation, Quality Control Labs, E&HS, and Quality
- Ensure the schedule of generation of CSV documentation is on track
- Support the execution of 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 suitability and compliance with industry regulations and company policies
- Support the development of qualification and validation programs
- Develop phase-appropriate ways to comply with regulatory requirements
- Support inspection readiness activities, Health Authority and Client audits, and corrective actions based on audit findings
- Support the implementation of CMMS (Computerized Maintenance Management System)
- Support Document Control Management activities (electronic storage architecture, levels of rights)
- Master's degree in engineering science or related program with 8+ years of relevant experience 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
- Strong focus on quality and attention to detail
- Problem-solving and critical thinking skills
- Motivated, self-starter with strong mechanical aptitude
- Ability to work independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
- Effective task/time management organizational skills
- Strong analytical and synthesis skills
- Ability to adapt to a working environment where all SMEs and team members are not onboarded yet and the Quality System is being established
Just - Evotec Biologics 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, our team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics. Our focus is to create access and value for a global market through scientific and technological innovation.
