Production Development Engineer Process

Join our Production Development team and continue shaping medical device production systems of tomorrow.
As a Production Development Engineer - Process you will play a key role in the development and implementation of new and improved production processes at Wellspect. In this role you will interact with various stakeholders to understand how products are configured as well as the requirements for efficient production flows. We are proud to have an in-house, highly automated medical device production with interconnected coating and media processes and multiple transport systems and packaging machines. And as a leading medical device manufacturer we have strict requirements on traceability and applications using in-line quality control.
Responsibilities;
Process project management in cross-functional development projects in various stages from concept to commissioning and handover.
Process design of media systems and applications, including e.g. pipes, pumps, valves, instruments and other production related equipment, as well as installation procedures.
Process risk assessment and User Requirements, functional and technical specifications
Commissioning and validation and training of operators
Develop documentation in compliance with our quality management system built on regulatory requirements from the European medical device directive and FDA quality systems regulations.
Integration of process equipment and components with a systems perspective on process control, traceability and communication with MES/SCADA and other production systems and equipment.
Establish and maintain working relationships with supplier including evaluations and supplier visits.


We think you are a positive, systematic and driven team player. You are open for challenges and enjoy working together with highly skilled and committed colleagues.
Qualifications / Background
an academic background, preferably in chemical or mechanical engineering or equivalent
experience in process design with focus on process media applications
an in-depth understanding process design including P&ID.
experience from working with technical specifications and external suppliers
technical project management experience
experience from testing/validation, preferably within life science or other highly regulated industry
knowledge of GMP
knowledge aseptic and CIP/SIP design is to be considered a plus
documentation and communication skills, in English as well as in Swedish


Wellspects’ production is in continuous evolvement and there are always new and interesting projects going on. We offer you a place to develop your skills as part of a cross-functional team and the medical devices we manufacture make a real difference in the lives of our users. That’s a reason to go to work!
For more information, please contact recruiting manager, Anders Fagerström, telephone +46 31 376 33 73.
Please apply no later than November 14th , 2021. Please note that we will review applications continuously, so be sure to send in your application as soon as possible.