qualification engineer

• previous experience working as a cvq senior engineer
• experience working on projects in cell and gene is preferred but the minimum is experience of biological manufacturing operations
• fluent in english (oral and writing)
• 5 years of experience as a commissioning and qualification engineer
• expert in the field of quality/validation/verification activities & control tests, cgmp and ema/fda, astm 2500
• extensive knowledge and demonstrated experience delivering commissioning and qualification for pharmaceutical / biotechnology projects including automation
• experience in clean utilities, facility, manufacturing within a pharma/biotech environment
• university degree in biology, biochemistry, chemical engineering, bioengineering, pharmacy, or other relevant discipline
• understanding of good practices in biopharmaceuticals, current industry standards, regulatory requirements and authority expectations regarding cqv
• a good understanding of technical installation, pid, equipment and buildings for the life science industry
• understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety
• use a risk-based approach for problem solving and prioritization of tasks
• good gmp background and quality system management
• blow a quality and compliance mindset through the qualification activities
• you have a field experience with:
• ocqv activities for upstream equipment
• ochange management
• oproject document management

as senior cvq you will own and lead the cvq portion of the project for a selected system(s) to ensure the cvq activities are completed safely, as per schedule and in compliance with the system requirements and specifications.he reports to the cvq workstream leader (c&q wsl)and is responsible for the execution, safe and compliant delivery of commissioning and qualification for their assigned systems commissioning verification and qualification.

• draft, coordinate review and approval of cvq documents (qra/dv/rtm/fat/sat/iov/vsr) following approved vmp and slia
• responsible for the planning, tracking and reporting of cvq status and risks/issues for the selected system(s). take appropriate corrective actions as required to ensure deadlines and milestones are achieved
• manage all cvq activities for the system(s), from design to field execution and to summary report approval
• drive verification testing, protocol execution, walk-downs, verification of system drawings and troubleshoot as required. conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
• review and accept turnover of equipment / system from construction group. ensures start-up of equipment/ system is completed in a safe and coordinated manner
• generate and or review change controls related to c&q and drive their closure in a timely manner
• ensures all personnel who perform c&q activities for the system(s) have relevant training assigned
• assist/ facilitate in the development of user requirement specifications (urs’s) and quality risk assessment for equipment and systems
• responsible for leading and managing their own and any internal/external partners to achieve the project objectives, budget, time schedule and functionality according to urs, gxp and hse requirements
• supports the project manager to set-up the commissioning & qualification engineering team with appropriate resources to meet project objectives
• directly reports major challenges to c&q wsl
• oversees, plans, conducts and coordinates the commissioning & qualification works for all of the project scope, monitors the ongoing progress, including the coordination of the project with internal stakeholders, regulatory authorities and agencies
• generation of system user requirements, cvq risk assessments, cvq plans, test cases and reports
• review and acceptance of contractor and vendor handover documentation
• running sequences and functional testing
• project change control and discrepancy management for assigned systems
• handover of systems to user team
• ensures readiness for inspections together with user quality organization
• responsible for formal hand over including documentation to the user organization

contract : permanent or freelance contract

salary : open to negotiation based on your experience

package (if employee) :

• 7€ meal voucher per workday
• 250€ / year in eco voucher
• 50€ tax free expenses
• company car or full compensation for travel expenses
• year-end bonuses
• 20 days statutory leave + 12 days of compensatory leave per year
• hospital coverage
• group insurance
• trainings
• gifts for special events