TFS HealthScience is a global, mid-sized Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise covers full-service solutions, resourcing, and functional service provider (FSP) offerings.

We are now seeking a System Engineer (GMP) to join our team. This assignment involves working on-site with one of our pharmaceutical manufacturing clients. In this role, you will have overall responsibility for the operation, maintenance, and further development of several IT and data systems used in a GMP-regulated environment.

Key Responsibilities:

• Manage the administration and operation of IT systems linked to regulatory activities
• Ensure data systems comply with current GMP requirements and regulatory guidelines
• Perform qualification and validation of new and existing systems
• Act as an expert resource during inspections and audits from authorities and clients
• Plan and coordinate maintenance, upgrades, and development projects related to data systems
• Handle license administration and documentation
• Contribute to the development of procedures and governing documents (SOPs)
• Train users on systems and support the creation of training materials
• Collaborate with both internal IT functions and external vendors on technical matters and procurement

System Environment (examples of systems in this role):

ECM, Chromeleon, PCS 1, MassLynx, Chemstation, Malvern Mastersizer, Unicorn Äkta Pure, Intab, Panalytical Xpert Pro XRPD, STARe, MicroDiss, Modde, Chemdraw, among others.

Your Profile:

• Experience working with data systems in GMP-regulated operations
• Strong understanding of requirements for data management, data integrity, and audit trail in regulated environments
• Experience with validation and qualification of computerized systems
• Ability to document work in line with regulatory requirements and draft governing documents
• Previous experience with inspections and audits is advantageous
• Excellent proficiency in both Swedish and English, spoken and written

What We Offer:

We offer a stimulating consulting role where you will have the opportunity to grow both professionally and personally. You will be part of an engaged team where collaboration, competence development, and high quality are central.

About TFS HealthScience:

Founded in Lund over 27 years ago, TFS has grown into a global full-service CRO with more than 800 employees across 40+ countries. We provide flexible solutions in clinical development and strategic resourcing across multiple therapeutic areas such as dermatology, neuroscience, oncology, and ophthalmology.

Our values — Trust, Quality, Passion, Flexibility, and Sustainability — guide everything we do and help us build strong, dedicated teams that make a difference together.

Together we make a difference.