You find yourself in the eye of the storm. The project manager wants to end the project, production is waiting to start, but you stand firm and take responsibility for quality assurance. You have planned the work for you and your team to ensure a good on-time delivery and maintain good proactive communication with suppliers. Do you recognize yourself in this scenario?
"As a validation manager, I help both small and large companies get their equipment and processes in order, both those who are already familiar with regulations and those who are new to life science. I love Plantvision's mix of challenges, joy and knowledge sharing and I have learned a lot during my time here." - Jessica Kjellberg
This is your role
You will bepart of a team at Plantvision that has high competence in validation. You will have the opportunity to develop and be challenged knowledge-wise based on your experience, act as a mentor and lead others.
The role involves the opportunity to:
- Qualify equipment and/or instruments, and computerized systems.
- Validate manufacturing and cleaning processes
- Lead validation activities with responsibility for strategy and documentation.
- Collaborate cross-functionally in project teams on requirements and risk analysis.
- Work with deviation management, CAPA, change requests, inspections, supplier.
- Develop work processes, review documentation and update SOPs where necessary.
We would like you to live in the Uppsala area and be able to visit customers in Mälardalen.
This is how you will shine
Through your way of always putting the customer in focus, working solution-oriented and delivering with a high drive, you will shine with us. It almost goes without saying that you as a person are also careful and quality-conscious. Since most of your work takes place at the customer, you should be able to manage the balance between being part of the assignment and actively contributing to your team. Sharing knowledge with each other is our main concern and something that makes us all grow!
You have the following knowledge, experience and skills
- You have over 5 years of experience in validation and qualification of production equipment and/or production processes in GXP controlled operations. We prefer that you have previous experience in validating computerized systems OR have over 5 years of technical experience in production and want to develop further in the field of quality.
- You have a university degree in engineering or science.
- Experience with ISO13485, GMP, GDP & 21 CFR Part 11, Eudralex Vol 4 Annex 11/ GAMP 5.
- You speak and write fluent Swedish and English.
- You have a pragmatic and solution-oriented approach to challenges.
- You are passionate about product quality, patient safety and data integrity.
- You have an understanding of structure, people and organizational awareness to be able to carry out change/improvement work.
- You have the ability to build long-term relationships and networks, which opens up opportunities for you and your colleagues in the future.
- You can deliver independently and work well in a team.
- You act as a role model by sharing knowledge and supporting colleagues.
Being part of Team PV
We are very proud to be a certified Great Place To Work company, which places us among the best employers in Sweden. The fact that we are also on the top list for Sweden's Best Workplaces is proof of the fantastic workplace culture we create together every day.
It is our employees who are the foundation of our success and we are very proud that the consultant himself drives his own development in everyday life in parallel with how we as a company work with skills development and sharing knowledge. We are committed, not only to the work we do, but also to the employee's everyday life as a whole. If we feel good and have fun together, we perform better together. Therefore, we place great emphasis on work planning, parental leave compensation and various wellness activities, to name a few examples.
Application
If you think we are the right workplace for you and you are the right person for us, send in your application today! Selection is ongoing. Access takes place according to agreement. If you have questions about this position, please contact: Consultant Manager Helena Bomfim, 076-7209184, helena.bomfim@plantvision.se
For this recruitment, we have adopted a strategic approach and therefore refrain from calls from recruitment, staffing and advertising companies.
