Secondment via YER
Industrial, Food, Feed, Pharma
Over deze vacature
Primary responsibilities for the Commissioning and Qualifications Engineer include: Commission and Qualify (C&Q) various process and laboratory equipment. Design and execute process validation studies for the large Scale API processes. Review and assess change control for API processes to determine impact on validated state. Apply Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements. Participate in efficiency and streamlining projects contribute to process improvement, technology transfer, new product introduction and other projects. Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc. Works with moderate work direction and is skilled and knowledgeable to the position.
- Facilitate and act as an owner regarding change control process / Tier
- Coordinate that the initiated changed will be drafted and approved (pre and post) in time
- Keep oversight and track the performance of all changes within the IPT (manage the planning)
- Prioritize and escalate in time
- Liaise with the different SME’s to collect the information regarding the change
- Write change control documentation
- Support other document writers
- Reach out to planning to schedule the change execution
- Identify the needed test material or identify the order and support the change requester regarding the test material request
- Transfer change instruction to the executers
- Update change control horizon board (status) and request for support if needed
- Ensure that the documentation will be completed (take care of the punch list items) and filed in the archive
- Update SDLC documentation
- Trackwise actions and updates
- Timely inform stakeholders regarding the changes and their status.
Organon aspires to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s well being.
You will be employed by YER and seconded to the company. We offer:
- Good employee benefits
- Excellent guidance from your consultant and YER's back office
- Friendly atmosphere and open culture
- Community/network with other technology professionals from a variety of multinationals
- Events and master classes with interesting speakers and attractive companies
- Min 2-3 years of experience as Technical Writer
- Good understanding of technical process and ability to translate / describe these in written technical documentation.
- Requires degree in Mechanical or Chemical Engineering
- Pharmaceutical experience C&Q experience a plus.
- Knowledge of GAMP (Good Automated Manufacturing Practice) SDLC (System Development LifeCycle) is a requirement
- Experience with packaging processes and GMP environment is preferred.
- Trackwise Application knowledge is preferred
- Advanced project management skills, able to summarize and clearly report out regarding status in all layers
- Keen, assertive person and self-steering
- Able to apply change control procedures into practice, knowing the right ratio
- Proficient verbally and in writing regarding Dutch and English language