BENGALURU · FULLTIME
CSV Engineer
Incepbio
Bengaluru · onsite · Posted 6d ago
Sourced from
Undisclosed2–5 yrsfulltimeBengaluru
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Section · 01
About this role
Experience: 2 to 5 years(Only immediate joiners should apply)
About the job
The CSV Engineer must be a self-starter, task oriented, maintain a strong work ethic, offer more than is asked for, and have the potential to see the big picture.
Responsibilities:
- Developing Engineering documentation such as URS, Design Specifications (FS, HDS, and SDS, etc.).
- Developing Deliverables & Documentation for BMS, EMS, ELVS & Automation System.
- 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 & 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.
- Understanding of PLCs, SCADA, DCS, Data Historians, reporting tools, OPC, network infrastructure, servers.
Qualifications & Other Requirements:
- 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.
- Strong verbal and written communication skills; excellent organizational and time utilization skills.
- Strong computer knowledge including Microsoft Office products. The ability to work on AUTOCAD will be an added advantage.
- A strong willingness to travel.
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
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Section · 02
Skills
Engineering DesignAutomationAutoCADCGMPGampgap analysisecCSVChange ControlEngineering Documentationelectrical systemsinstrument calibrationImpact Assessmentbuilding managementControl SystemCommunication SkillsHVAC