**Project Engineer Role Summary**
* Deliver technical expertise to internal teams, ensuring the optimal performance and compliance of manufacturing and laboratory equipment.
The ideal candidate will possess a strong understanding of Automation & Control principles and be able to communicate complex technical concepts effectively. Strong diagnostics and maintenance skills for PLC, HMI, and SCADA systems are also essential. Experience with Siemens PLC/HMI/SCADA (Step 7, WinCC Flex 2008, TIA Portal, WinCC/PCS7) is highly desirable, as well as familiarity with other PLC/HMI/SCADA manufacturers. Knowledge of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11) is also important.
Responsibilities include:
1. Providing IT/OT expertise to internal customers to ensure equipment availability, performance, and compliance requirements are met.
2. Identifying and implementing improvements to manufacturing and lab systems.
3. Assisting in regulatory audits by providing IT/OT expertise when required.
4. Generating and maintaining disaster recovery plans, procedures, and records for computerised systems.
5. Supporting validation activities for computerised systems (commissioning, qualification, startup).
6. Driving vendor relationships on support activity and checking SLA adherence.
This is an exciting opportunity to join a leading biopharmaceutical company and contribute to improving people's lives and health outcomes.