Project Location: DenmarkProject Type: PharmaceuticalKey ResponsibilitiesDesign, develop, and implement automation systems for pharmaceutical and biotechnological production facilities (e. g. , SCADA, PLC, DCS, MES). Collaborate with process, mechanical, and validation teams to deliver integrated, compliant solutions. Configure and program PLCs (Siemens, Rockwell, etc. ) and HMIs according to functional specifications. Lead or support FAT, SAT, and commissioning activities across new and existing facilities. Ensure systems are designed and implemented in alignment with GAMP 5, GMP guidelines, and 21 CFR Part 11. Support project documentation including Functional Design Specifications (FDS), software test protocols, and user requirements specifications (URS).
Engage in continuous improvement initiatives to increase automation efficiency, reliability, and data integrity. Participate in client meetings and liaise with vendors and suppliers for equipment integration and controls architecture. Stay up to date with industry trends and regulatory developments in automation and life sciences manufacturing. QualificationsBachelor’s or Master’s degree in Automation Engineering, Electrical Engineering, Mechatronics, or related discipline. 3+ years of experience in automation engineering, preferably within the pharmaceutical or biotech sector. Proven experience with automation platforms such as Siemens S7, PCS 7, Rockwell/Allen Bradley, Emerson DeltaV, or similar. Knowledge of industry standards:
GAMP 5, GMP, ISA-88/95, and 21 CFR Part 11. Experience with computerized system validation (CSV) and lifecycle documentation. Strong understanding of process automation for cleanrooms, filling lines, bioreactors, and utilities (WFI, HVAC, CIP/SIP). Excellent communication skills in English (spoken and written); knowledge of a Scandinavian language is a plus. Willingness to travel or work on-site with clients, depending on project requirements.
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