Process Specialist

at  Ferrosan Medical Devices

INTRODUCTION

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you. With us, you will not only have the opportunity to influence the production and development of our products - you will also have the opportunity to develop in our Process Support team. We are now looking for 3 new, curious, and dynamic teammates. One of our former Process Engineers, Jacob Thor Reinhold, who recently changed department after an internal promotion, says the following about the job:
“If you thrive in a high paced work environment, and you love to interact with the production line and team - this position is for you. You’ll be an essential part of the organization, where GMP will be your top priority. To ensure that the production is running efficiently and under our specifications, while also supporting our development projects, is going to be your role as a Process Supporter in FeMD. In short, you’ll be the backbone of our operations.”

POSITION OVERVIEW

The Process Support department is divided into 2 teams and production areas: Basis and SFI – consisting of 23 committed and skilled employees in total. It is, among other things, our responsibility that our production processes and equipment are always in a validated state and are thus ready to produce on.
A large part of this is running smaller projects and CR-cases to ensure that necessary improvements and optimizations in production are implemented. In addition, it is our responsibility to handle production deviations, continuous updates of instructions and procedures so that they meet current authority requirements along with driving and implementing continuous improvements. The department supports the production and also manages batch reviews.

CURIOUS, INDEPENDENT AND EXPERIENCE WITHIN PROCESS SUPPORT

We are looking for a technically grounded profile that can independently find the way forward and make decisions. You are motivated by working in a dynamic environment and you are good at planning and take pride in moving tasks forward and meeting deadlines. As a person, you look positively on the challenges that working life can offer. You thrive working independently and in groups across departments and organizations. You can challenge those around you in an empathetic and respectful way - and do not fall into a headwind.

In addition, your CV contains:

• A relevant academic background; engineer, chemist, pharmacist or similar, preferably with experience from a production environment or relevant experience from an internship/student job
• Experience working with change requests, requirements specifications, validation, or testing
• Experience of working in a GMP-regulated environment
• Good written and verbal competencies in both Danish and English

Together with the rest of the team, you will be responsible for the daily support of our production lines. You will learn our processes in detail and gain a good overview of the documentation used in production.
For your workday, this means that you will be present in the production, holding systematic problem-solving sessions, and handling deviations with corresponding corrective and preventive actions. In addition to supporting daily production, you will also be responsible for implementing improvements and participating in projects.

Your primary tasks will be:

• Handling deviations; includes close collaboration with operators, technical department, QA, and others
• General support to production
• Facilitating systematic problem solving and driving corrective actions to completion
• Improvement and optimization of our standards, which we work according to
• Implementing ongoing improvements in the form of minor projects, CAPA, or change cases
• Possibility to develop into a process owner for one or more of our production processes

You must be able to work in a structured and analytical manner, and to be successful in the job it is important to be able to collaborate with colleagues in different functions. You will also be a part of cross-functional projects, supporting development projects and the implementation of new products, processes, equipment and more.