Service Engineer

Key Responsibilities:

- Lead and execute on-site installation, commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) for fermentation and bioprocessing systems.

- Develop, modify, and troubleshoot automation logic and control systems, including PLC, SCADA, and HMI interfaces.

- Prepare, update, and manage technical documents such as Functional Specifications (FS), Design Specifications (DS), Hardware/Software Design Specifications (HDS/SDS), assessment documents (C/FRA/EMRA/ERES, etc.), and validation protocols (IQ/OQ/PQ).

- Revise documentation based on customer and internal review feedback to ensure accuracy and compliance.

- Ensure proper printing and delivery of finalized documents to customer sites in accordance with company procedures.

- Perform system calibration, loop checks, and functional testing of instruments and control panels.

- Support integration with higher-level systems such as MES, DCS, or central SCADA, ensuring data integrity and compliance.

- Provide on-site technical support during project execution, ensuring system functionality and adherence to regulatory standards (cGMP, 21 CFR Part 11, ISO, ISPE).

- Collaborate with OEM design, validation, and project teams to review engineering documentation (P&IDs, wiring diagrams, IO lists).

- Train end-users on system operation and provide post-commissioning support.

- Maintain accurate documentation for automation systems and update project records as required.

- Serve as a communication liaison with customers to understand needs and deliver professional technical support and consultation.

Qualifications:

- Bachelors degree in Engineering, Automation, Biotechnology, or a related field.

- Proven experience with fermentation/bioprocessing systems and automation controls (PLC/SCADA/HMI).

- Strong knowledge of regulatory standards such as cGMP, 21 CFR Part 11, ISO, and ISPE guidelines.

- Experience drafting, revising, and managing technical and validation documentation in a regulated industry.

- Ability to perform system testing, calibration, and troubleshooting on-site.

- Excellent communication skills and ability to work collaboratively with customers and cross-functional teams.

- Willingness to travel to customer sites as needed for project execution and support.