Validation and Qualification Expert
2 weeks ago
We are seeking a highly skilled Validation and Qualification Expert to join our team at FUJIFILM Diosynth Biotechnologies in Hillerød, Denmark.
About the RoleIn this role, you will be responsible for preparing, performing, and documenting commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. You will also participate and execute change controls, plan and participate in projects with validation impact, and prepare validation planning and reporting documents for product campaigns.
You will have the opportunity to work closely with cross-functional teams, including Engineering, Quality Control (QC), Quality Assurance (QA), Manufacturing, Automation, Maintenance, and others.
Main Responsibilities- Preparation, performance, and documentation of commissioning, IQ, OQ, and PQ activities
- Participation and execution of change controls
- Planning and participation in projects with validation impact
- Planning, execution, and documentation of all phases of cleaning validation
- Preparation of validation planning and reporting documents for product campaigns
- Writing and updating validation procedures and documents
- Participation in audits and inspections, answering regulatory requests
To be successful in this role, you will need a Bachelor's degree or higher in Engineering or a relevant discipline, along with at least 3 years of relevant industry experience.
You should have demonstrated knowledge of industry practices, practical experience, and interest in hands-on validation execution.
You should be conscious of lean ways of working and able to apply a risk-based approach to deliver efficient qualification.
You should have strong technical writing and excellent communication skills, as well as a team-oriented mindset and a friendly, can-do behavior.
Compensation PackageWe offer a competitive compensation package, including a salary of approximately €60,000 - €80,000 per year, depending on experience.
We also offer a range of benefits, including opportunities for individual growth and professional development, as well as a dynamic and supportive work environment.
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