Position Overview
Automation Engineer Pharmaceutical Domain
We are looking for an Automation Engineer with 3+ years of experience in industrial automation, preferably within the pharmaceutical, biotech, or regulated manufacturing industry.
Key Requirements
- 3+ years of hands-on experience with PLC, HMI, and SCADA systems.
- Strong experience with Siemens (TIA Portal, S7 Series) and/or Rockwell Automation (Studio 5000, ControlLogix, CompactLogix) platforms.
- Understanding of pharmaceutical regulatory and compliance requirements, including:
- FDA 21 CFR Part 11
- GAMP 5
- cGMP / GMP
- Computerized System Validation (CSV )
- Experience in preparing and reviewing validation documentation such as URS, FS, IQ, OQ, and PQ.
- Knowledge of audit trails, electronic records, electronic signatures, and change control pro...