IncepBio
Website:
incepbio.com
Job details:
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.
Click on Apply to know more.
