Position: Sr. Automation Engineer (BMS/EMS/ELVS) — Biotech/Pharma
Location: Hyderabad/Ahmedabad, India
The Automation Engineer must be a self starter, task oriented, like projects, maintain strong work ethic, offer more than is asked for, and have the potential to see the big picture.
- Engineering Activities like BMS, EMS, ELVS & Automation System Designing, Hardware Selection, Network Architecture Design, Control & Field Panel Design & Specifications, Control Schemes for Drive Panel & MCC panel, Panel FAT etc.
- Developing Engineering documentation such as URS, Design Specifications (FS, HDS, and SDS, etc.).
- Developing Deliverables & Documentation for BMS, EMS, ELVS & Automation System.
- Well versed with ELVS Systems like Access Control System (ACS), Door Interlocking System (DIS), Data & Voice System, CCTV System, Public Addressing (PA) System etc.
- Testing, Commissioning (FAT, SAT) and Qualification of the BMS, EMS, ELVS & Process Control system (Generation & Execution of Qualification Protocols).
- Well versed with Control System Validations for Process Control System (PCS), Building Management System (BMS), Environmental Monitoring System (EMS) & Extra Low Voltage System (ELVS).
- Development of SOP's, Change Control Management, Deviation Handling and CAPAs., Root Cause Analysis & Failure Investigation., Leveraging Assessment etc.
- Development of Traceability Matrices, GAP Analysis and Final Reports.
- Performing Risk assessments, developing Risk Mitigation Plan and documenting Risk Assessment Reports (RAR), Performing Component Level Impact Assessment (CLIA) for BMS, EMS, ELVS & PCS system.
- Ability to effectively lead projects, coordinate contractors, junior level personnel and drive results.
- Working closely with Systems Integrators, Automation leads, HVAC Leads & Process leads.
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
Knowledge and Skills
- Technical understanding and experience on various platforms such as Honeywell, Siemens, Johnson Controls, United Technologies (Carrier Race), Rockwell, Schneider etc.
- Knowledge of CAV, VAV box, DDC Controllers, DDU's, BMS/EMS Instruments & Control Valve, EC Fan Controllers etc. shall be required.
- Knowledge of ACS, DIS, Data & Voice, CCTV, PA Systems shall be required.
- Understanding of PLCs, SCADA, DCS, Data Historians, reporting tools, OPC, network infrastructure, servers, network troubleshooting.
- Specific knowledge of Industrial Communication Protocol like Ethernet IP, Profibus DP, Profinet, Modbus RTU, Modbus TCP/IP, BACnet, LonWorks, M-BUS etc.
- Specific Knowledge on Operation & Configuration of VFD - Siemens/Rockwell/Danfoss & EC Fan Controllers.
Qualifications & Other requirements
- B.E. or B.Tech degree in Electrical/Instrumentation/Electronics with 5 to 7 years experience.
- Minimum of 3 years Experience in Biopharmaceutical or Pharmaceutical Industry.
- Proficient knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially related to sanitary and sterile operations, is essential.
- Knowledge of Electrical systems, Instrumentation, Instrument Calibration, Process controls, Machine Automation etc. will be an added advantage.
- Shall be capable of developing engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines.
- Must comply with cGMP requirements (gowning, documentation, procedures) and have the ability to generate and gain approval of validation documentation.
- Must possess a good understanding of clean room or classified area requirements.
- Individual will be expected to use creativity and innovation to address urgent and/or complex problems and propose solutions and have the ability to work autonomously on assignments and projects.
- Strong verbal and written communication skills; excellent organizational and time utilization skills.
- Strong computer knowledge including Microsoft Office products. Ability to work on AUTOCAD will be an added advantage.
- Environmental compliance experience.
- Relate to people at all levels of the organization, including diverse cultures.
- A strong willingness to travel.
- Valid International passport without any legal obligations in terms of obtaining visa.
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