OT Compliance Engineer
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Søborg
Are you ready to join our journey and apply data engineering to enable the digital transformation of a successful company? And are you ready to join our newly established OT team (Operational Technology) where we prioritize collaboration, knowledge sharing and having fun? Then this is your opportunity to join the ride.
At Ferrosan Medical Devices, we are looking for an OT compliance engineer who will be an important part of our compliance projects related to Operational Technologies (OT) and our digitalization strategy.
Join our OT team
We develop and produce a portfolio of hemostatic products to minimize bleeding challenges in surgeries. Our products are registered as medical devices and sold internationally to more than 100 countries. All main functions in the company, including our production facilities, are based in Soeborg, Denmark, so everyone sits door to door with easy access to each other.
You will be joining our newly established OT team. Our role is to improve, expand, maintain and support our qualified production network and to ensure consistent compliance with regulatory requirements.
The job
This is a job for those who are excited to work with technologies, validation, and compliance in OT projects.
Specifically, you will:
• Drive compliance project in mapping our computerized systems in Operations, conduct System Impact Assessments and develop corresponding SOP’s.
• take responsibility for validation activities for the project(s) e.g. planning, documentation, coordination and reporting and you are quality-minded with good ability to execute within deadlines.
• conduct periodic evaluations.
• conduct change management in accordance with our quality requirements.
• assess and manage risks, ensure OT system security in accordance with our predefined risk and security requirements.
• contribute to optimizing our approach to OT compliance.
“This position gives you the opportunity to contribute to the development and improvements of the future compliance projects related to OT within FeMD in a great work environment” says Manager Carsten Johannsen.
OT experience within a GxP-regulated environment
With a good amount of professional and personal stamina, you thrive in a busy environment where you cannot always find detailed manuals for everything. Like us, you handle things through dialogue, and you trust that your colleagues make the right decisions.
Furthermore, we imagine that you:
• Hold an academic degree within IT/OT and/or Computer Science. Preferably you have some years of experience with data engineering in an enterprise context, but our priority is to find a person with the right technical skills and mindset regardless of experience.
• Have experience with IT/OT testing, creating protocols and test plans in a GxP environment as well as MS Windows Server and client platforms (Siemens HMI panels) will be considered an advantage.
• Have experience preferably from pharma, medical devices or from other industries where quality and regulatory compliance is vital to succeed.
• Preferably have experience with GxP production network, automation, 21 CFR Part 11 and data integrity.
• Preferably have experience with GMP requirements and the GAMP 5 guideline.
• Possess strong oral and written communication skills in English.
Want to join the team?
Send Your application along with your CV via the link below as soon as possible. We will process the applications as we receive them.
Questions? Do not hesitate to contact Manager Carsten Johannsen on +45 5213 2874.
We look forward to hearing from you.
About us
Since 1947, we have developed and manufactured haemostatic products, used by healthcare professionals to stop bleeding during surgical operations. Our focus is to develop solutions to clinical problems within biosurgery – and to provide healthcare professionals with new innovative therapeutic alternatives that make a positive difference to them and ultimately improve patient outcomes. Read more about us here
At Ferrosan Medical Devices, we are looking for an OT compliance engineer who will be an important part of our compliance projects related to Operational Technologies (OT) and our digitalization strategy.
Join our OT team
We develop and produce a portfolio of hemostatic products to minimize bleeding challenges in surgeries. Our products are registered as medical devices and sold internationally to more than 100 countries. All main functions in the company, including our production facilities, are based in Soeborg, Denmark, so everyone sits door to door with easy access to each other.
You will be joining our newly established OT team. Our role is to improve, expand, maintain and support our qualified production network and to ensure consistent compliance with regulatory requirements.
The job
This is a job for those who are excited to work with technologies, validation, and compliance in OT projects.
Specifically, you will:
• Drive compliance project in mapping our computerized systems in Operations, conduct System Impact Assessments and develop corresponding SOP’s.
• take responsibility for validation activities for the project(s) e.g. planning, documentation, coordination and reporting and you are quality-minded with good ability to execute within deadlines.
• conduct periodic evaluations.
• conduct change management in accordance with our quality requirements.
• assess and manage risks, ensure OT system security in accordance with our predefined risk and security requirements.
• contribute to optimizing our approach to OT compliance.
“This position gives you the opportunity to contribute to the development and improvements of the future compliance projects related to OT within FeMD in a great work environment” says Manager Carsten Johannsen.
OT experience within a GxP-regulated environment
With a good amount of professional and personal stamina, you thrive in a busy environment where you cannot always find detailed manuals for everything. Like us, you handle things through dialogue, and you trust that your colleagues make the right decisions.
Furthermore, we imagine that you:
• Hold an academic degree within IT/OT and/or Computer Science. Preferably you have some years of experience with data engineering in an enterprise context, but our priority is to find a person with the right technical skills and mindset regardless of experience.
• Have experience with IT/OT testing, creating protocols and test plans in a GxP environment as well as MS Windows Server and client platforms (Siemens HMI panels) will be considered an advantage.
• Have experience preferably from pharma, medical devices or from other industries where quality and regulatory compliance is vital to succeed.
• Preferably have experience with GxP production network, automation, 21 CFR Part 11 and data integrity.
• Preferably have experience with GMP requirements and the GAMP 5 guideline.
• Possess strong oral and written communication skills in English.
Want to join the team?
Send Your application along with your CV via the link below as soon as possible. We will process the applications as we receive them.
Questions? Do not hesitate to contact Manager Carsten Johannsen on +45 5213 2874.
We look forward to hearing from you.
About us
Since 1947, we have developed and manufactured haemostatic products, used by healthcare professionals to stop bleeding during surgical operations. Our focus is to develop solutions to clinical problems within biosurgery – and to provide healthcare professionals with new innovative therapeutic alternatives that make a positive difference to them and ultimately improve patient outcomes. Read more about us here
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 3.3.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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