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Automation Senior Specialist
2 tygodni temu
- Coordinate investment and modernization projects in industrial automation.
- Initiate and manage change control processes and implement CAPA activities.
- Administer computerized systems, including user management, data backups, and system restoration.
- Support periodic reviews and technical audits of computerized systems.
- Participate in CSV qualification processes.
- Develop procedures, instructions, risk analyses, and specifications for automation systems and CSV.
- Report system errors and identify root causes.
- Provide necessary reports and documentation.
- Higher education diploma with relevant professional qualification.
- Knowledge of industrial automation solutions and computerized systems in the pharmaceutical industry.
- Programming skills in PLC controllers (Simatic S7-300, S7-1500, TIA Portal software, WinCC SCADA 7.x system).
- Proficiency in IT technology, LAN networks, industrial communication networks, Windows OS, and Active Directory.
- Understanding of GxP quality assurance processes (change control, deviations, CAPA, risk analyses).
- Familiarity with GAMP guidelines, CFR21 Part 11, and Annex 11.
- Experience in CSV qualification processes.
- Strong organizational skills and ability to work under pressure.
- Effective work organization, problem-solving, communication, teamwork, and adaptability.
- Proficiency in Polish
- English - min.B2
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