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Senior Validation Engineer
Il y a 2 mois
We are seeking a highly motivated and experienced Senior Validation Engineer to join our team in Toulouse, France. As a key member of our Commissioning, Qualification and Validation (CQV) team, you will be responsible for supporting the generation and review of key deliverables, collaborating with multi-disciplinary teams, and ensuring the schedule of CQV documentation is on track.
Key Responsibilities- Support the development of User Requirements Specifications, System Impact Assessments, and Criticality Assessments for Analytical Equipment.
- Collaborate with external partners, consultants, Quality Control, Manufacturing, Process Engineers, E&HS, and Quality teams.
- Assure that the schedule of generation of CQV documentation is on track.
- Support the execution of 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.
- Support the development of qualification and validation programs at Evotec WD.
- 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 and Document Control Management activities.
- Master's degree in engineering science or a 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 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.
- 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 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.
- Verbal and written communications skills in both English and French.
Evotec WD 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 state-of-the-art labs and cGMP clinical manufacturing plant are currently co-located in Seattle's South Lake Union neighborhood, and we are expanding our innovative platform and footprint with new facilities in the Seattle area and Toulouse, France.
We are committed to diversity and consider all applications, including those from people with disabilities, with equal competences.