Job Description
Job Overview:
We are seeking a skilled and detail-oriented Service Engineer to support the installation, commissioning, documentation, and life-cycle management of fermentation and bio-processing systems. The ideal candidate will have strong technical expertise in automation and control systems, combined with rigorous documentation practices and a commitment to regulatory compliance. You will play a key role in ensuring systems are delivered, validated, and maintained to the highest standards while providing exceptional technical support to customers and internal teams.
Key Responsibilities:
- Lead and execute on-site installation, commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) for fermentation and bio-processing 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 (c GMP, 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:
- Bachelor’s degree in Engineering, Automation, Biotechnology, or a related field.
- Proven experience with fermentation/bio-processing systems and automation controls (PLC/SCADA/HMI).
- Strong knowledge of regulatory standards such as c GMP, 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.
We are seeking a skilled and detail-oriented Service Engineer to support the installation, commissioning, documentation, and life-cycle management of fermentation and bio-processing systems. The ideal candidate will have strong technical expertise in automation and control systems, combined with rigorous documentation practices and a commitment to regulatory compliance. You will play a key role in ensuring systems are delivered, validated, and maintained to the highest standards while providing exceptional technical support to customers and internal teams.
Key Responsibilities:
- Lead and execute on-site installation, commissioning, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) for fermentation and bio-processing 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 (c GMP, 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:
- Bachelor’s degree in Engineering, Automation, Biotechnology, or a related field.
- Proven experience with fermentation/bio-processing systems and automation controls (PLC/SCADA/HMI).
- Strong knowledge of regulatory standards such as c GMP, 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.
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