Job Description
Want to apply your technical expertise at one of the biggest industrial players in the Netherlands? Do you enjoy working in a high-tech environment where you make an impact with products that truly matter? Then we are looking for you!
For our department we are looking for a Senior Validation/Qualification Engineer.
Welcome to our team
You will be part of the validation and calibration team of the technical department, which is responsible for coordinating, executing and reporting validations, qualifications and calibrations for our various sites. We work closely with various departments, such as the integrated process teams, centers of expertise and the Research & Development department.
As a Senior Validation/Qualification Engineer you are the expert in the field of validation, qualification and calibration. You develop and manage validation and qualification protocols and actively contribute to improving our processes. You analyze data, identify improvement opportunities and support these with clear improvement proposals. This increases not only productivity, but also safety and quality within our organization.
About the role
In the first year you are expected to show affinity with the industry and relevant areas of knowledge. This forms the basis for effective collaboration within the team. You contribute to preventing backlogs and ensuring quality.
The goal is to be fully trained after one year and able to contribute independently, with the team's workload noticeably reduced. Success is assessed based on independence and impact on the team.
Distribution of work:
•Review of reports (25%)
•User Requirements Specification input/evaluations (20%)
•Technical discussions with stakeholders (25%)
•Improving and safeguarding procedures (20%)
•Technical input on deviation management (10%)
Stakeholders: suppliers, process owners, direct colleagues and engineering teams.
What will you do?
•Drawing up, checking and managing validation, qualification and calibration protocols, including reports and annual plans.
•Performing data analyses and registrations in the CMMS system, with a focus on continuous process improvement.
•Reviewing technical documentation such as qualification and 'as built' reports, and supporting audits.
•Acting as Subject Matter Expert (SME) in the field of qualification and calibration within projects and on compliance issues.
•Securing knowledge and supporting departments with technical expertise and training.
•Ensuring compliance with safety, health and environmental policy and relevant laws and regulations.
Your profile
•HBO diploma in a technical field and 5–7 years of experience in the pharmaceutical industry.
•Demonstrable knowledge of GMP and experience with validation and calibration processes.
•Strong in analyzing technical documents and writing clear reports.
•Communicative in Dutch and English.
•Analytically strong, with a customer-oriented and service-oriented attitude.
•Flexible, proactive and able to work independently as well as in a team.
What we offer
Working at our organization means working together on health in an international work environment with dedicated colleagues. You get all the room to develop yourself and show who you are. You can also count on attractive employment conditions, such as:
•A competitive salary.
•35.5 vacation days.
•8% holiday allowance and 3% year-end bonus.
•Bonus scheme.
•An excellent pension.
•Various training modules and growth opportunities.
Questions about this vacancy?
Send your question, including the vacancy number and vacancy title, to the following email address: [email protected]. Applications can only be submitted via the website.
Required Skills: Calibration of Equipment, Computerized Maintenance Management Systems (CMMS), Process Instrumentation, Protective Security, R&D Engineering
