The Operational Expert in Technical Development is responsible for strategic operational support, implementation of laboratory systems, and administration of IT systems. Your tasks will also include laboratory equipment management, creation of GMP-compliant documentation, and preparing the organization for audits and inspections.

Your Responsibilities:

• Implementation and administration of production and laboratory information management systems (SMB, working knowledge of software related to USP, DSP and AD).
• Logging and handling of failures in SAP MTS, fault assessment, equipment labeling, communication with the MTN team.
• Preparing procurement documentation (URS, PR, offer and contract evaluation), overseeing equipment installation and qualification, managing CAPEX documentation.
• Creating and updating system procedures, data integrity control, planning and conducting validations.
• Preparing laboratories for national and international audits and inspections.
• Cooperation with suppliers of equipment, reagents, and logistics companies.
• Implementation of new solutions to improve laboratory operations.
• Documenting shipments and receipts of equipment deliveries.
• Carrying out tasks as agreed with the manager and adhering to GxP standards.

Our Expectations:

• Minimum 5 years of laboratory experience in a regulated environment.
• Higher education in chemistry, biotechnology, molecular biology, pharmacy, or related fields.
• Knowledge of GMP, 21CFR, FDA requirements.
• Good command of English (both spoken and written).
• Very good knowledge of the MS Office package.
• Teamwork skills, independence, and attention to detail.
• Experience in preparing validation documentation and managing computerized systems.

We Offer:

• Competitive salary.
• Interesting professional challenges.
• Private healthcare.
• Life insurance.
• Employee pension program.
• An extra day off.
• And more…