Computer System Validation Engineer

Do you want to participate in the task of designing and implementing the foundation for Digital Manufacturing and IIoT? We are in the process of launching several large projects which includes digital factories and we are therefore looking for new colleagues with IT infrastructure experience in a broad context.

Primary Duties and Responsibilities: Manufacturing IT is a full-service provider of IT solutions within manufacturing for the pharma and biotech industries. We work with consultancy, design, implementation, and validation of IT solutions.

Our focus is Manufacturing Execution System (MES), IT infrastructure and Software Engineering as well as custom-made IT solutions needed in a pharma/biotech facility. In our daily life, we deliver turn-key IT solutions through complex projects and act as individual consultants or advisor within our focus areas.

As an engineer in Manufacturing IT, your main tasks will be:

• Participate in / drive quality planning
• Give input to requirement specifications
• Participate in Quality Risk activities
• Contribute to IT risk assessments
• Contribute to and supervise test and verification
• Conduct IT compliance assessments
• Provide general IT Compliance consulting to customers

Every day you will work in an ever-changing, project-driven environment side by side with some of the most skilled and passionate experts in the world… Your colleagues. You will become a part of an active and challenging environment in Manufacturing IT with more than 60 dedicated and experienced consultants.

Required Qualifications:

• You have a Master or bachelor’s degree and min 5 years of qualification / validation experience from the pharmaceutical industry or from a consultancy company.
• You are familiar with the US and European GMP rules, the GAMP guide, the ASTM-2500 and the ICH guides.
• Expertise within Automation & IT technologies like PLC, SCADA, DCS, IT infrastructure, software development or MES systems is an advantage.
• You are passionate about working in the area of quality management of computerized systems in a pharmaceutical or biotech environment.

Your personal profile:

• Proficiency in spoken and written Danish and English
• You have a personal drive and are passionate about your work
• Pro-active and cooperative
• Be comfortable with Customer relations

We will teach you what you don’t know! The most important is your experience and your personal profile!

If you have any questions about the job, please contact Manager Steffen Rasmussen, +45 30 79 89 69.

Deadline of application is 15 May 2021.

We will invite to interviews on a running basis.