Validation Engineer

Join our Production Development team and continue shaping medical device production systems of tomorrow.
As a Validation Engineer you will be a key person in the qualification and commissioning of new and improved production processes. The role will give you the chance to work with existing production processes well as development of new production processes. At Wellspect Healthcare we are proud to have a highly automated production in-house with chemical processes, multiple transport systems, packaging machines and an order controlled batch process.
Responsibilities
Develop validation strategies and validation plans in close cooperation with Production Engineers, Process Managers and external equipment suppliers to ensure our long-term product quality
Understanding product risks and requirements as wells as participating in process risk assessments
Participating hands on in validation and test run activities in clean room production
Conclude and report the outcome of the validation. Summarize test results and determine whether a process meets its’ acceptance criteria.
Develop documentation in compliance with Wellspects’ quality management system built on regulatory requirements from the European medical device directive and FDA quality systems regulations.
Improving process validation methods/SOPs for more efficient ways of working


Qualifications / Background
an academic background (M.Sc./B.Sc.) with experience in Quality Management Systems /Production/Product Development Process preferably within the life science industry
understanding of the V-model (DQ/IQ/OQ/PQ) for process validation and the interpretation of ISO/GMP standards
experience in process capability measurements/calculations and other statistical analyzes
experience working with technical specifications and external suppliers
some experience from production and quality control/auditing
preferably some Lean/Six sigma experience
excellent documentation and communication skills, in English as well as in Swedish


We think you are a structured and proactive team player. You are open for challenges and enjoy working with many different contacts surfaces. You will be working with highly skilled and committed colleagues. Come join our team!
Please note that we will review applications continuously, so be sure to send in your application as soon as possible.

We look forward hearing from you