CSV Engineer

Incepbio Pvt Ltd; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Incepbio Pvt Ltd is seeking a CSV Engineer in Bengaluru to drive the development and qualification of BMS, EMS, ELVS and related process-control systems.

You will create URS, design specifications, SOPs and risk assessments while coordinating with automation leads and system integrators to ensure timely delivery and regulatory compliance in a GMP environment.

Qualifications

• Biopharmaceutical manufacturing and process equipment knowledge is essential.
• Experience with GMP/CGMP and regulatory guidelines is required.
• Capable of developing engineering design documents and test plans.

Responsibilities

• Develop engineering documentation such as URS and DS (FS/HDS/SDS).
• Test, commission, and qualify BMS, EMS, ELVS and Process Control systems.
• Lead risk assessments, CAPAs, RCA and failure investigations.
• Coordinate with systems integrators and automation leads on project delivery.
• Ensure compliance with ISPE, PDA, FDA, ICH, ISO and EU GMP guidelines.

Skills

Honeywell

Siemens

Johnson Controls

Carrier

Rockwell

Schneider

AutoCAD

Tools

AutoCAD

Job description

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.