Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets .
It's going to be an exciting future—come be a part of it!
For the Quality Control Analytical Chemistry – Equipment Management & Cleaning department in Oss, we are currently looking for candidates for the position of:
(junior) Computer Systems Validation Engineer
Quality Control Analytical Chemistry (QC-AC) is part of the Qualilty Operations - Pharmaceutical Operations Organon Oss and consists of various laboratories and an Equipment, Management & Cleaning (EMC) department. The labs are responsible for the correct and timely execution of physical and chemical tests on final products, raw materials, APIs and packaging materials. The EMC department supports the labs with, among other things, solving equipment-related problems, maintenance and calibration of lab equipment, ordering chemicals, cleaning laboratory glassware and carrying out and managing investment projects.
As a (Junior) Computer Systems Validation Engineer (internal: Qualification & Validation Engineer) you are responsible for the implementation of all facets of the life cycle of computerized laboratory equipment such as a TOC, ICP or coulometer.
You ensure that the SDLC qualification documents, including associated procedures, are drawn up in close collaboration with the SME and Quality Assurance that comply with all internal and external regulations, including all data integrity requirements. A qualification report is drawn up after the test phase has been completed. After successful qualification, the system is released for (release) analyses.
During the operational phase it is your job as a (Junior) Computer Systems Validation Engineer to keep the system in a qualified state. Any changes to the system are carried out under change control. By by performing so-called periodic reviews, the qualified status is demonstrated. You coordinate any deviations as soon as out-of-calibrations occur. At the end of the life cycle, the laboratory system must be retired and the data is stored securely. You prepare the necessary documents yourself.
Tasks and responsibilities
- Drawing up qualification protocols for computerized laboratory equipment;
- Act as project leader for the qualification of laboratory equipment; commissioning tests (accepting the work performed) and drawing up final reports;
- Drafting change requests arising from any technical issues and ensuring that changes are implemented correctly;
- Making improvement proposals based on analysis to improvement/optimization including the correct implementation of these proposals according to the applicable procedures;
- Independently drafting all necessary information, making proposals for improved procedures and instructions related to management, maintenance and operation of equipment;
Acting as Subject Matter Expert (knowledge carrier) for the qualification of laboratory equipment;
- Minimum HBO Chemical, Pharmaceutical or (Process) Technical, background;
- Minimum of 0-3 years of relevant work experience in a laboratory environment;
- Experience with and knowledge of project management;
- Experience in writing qualification documentation in the English language;
- Experience with data integrity and other relevant guidelines
- Solution-oriented thinking within the framework of GMP;
- Good quality and safety awareness;
- Result-oriented, innovative capacity and driven to improve;
- Well-developed focus on customers, quality and compliance;
- Able to work both independently and in a team;
- Excellent communication and social skills to different levels in word and writing.
Working at our company means working together for health in an international working environment with dedicated colleagues. You get all the space to develop yourself and show who you are. You can also count on attractive employment conditions:
- A competitive salary;
- 35.5 vacation days;
- 8% holiday allowance
- Annual Incentive Plan;
- An excellent pension;
- Travel allowance
- Different training modules.
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.