CSV Engineer

Greythr; Bengaluru; On-site; INR 800,000 - 1,500,000; Full time

Job summary

Greythr is seeking a CSV Engineer with 2–5 years of experience to develop engineering documentation and lead qualification activities for BMS, EMS, ELVS, and process control systems.

The role involves testing, commissioning, SOP development, deviation handling, and collaboration with systems integrators and cross-functional teams in a GMP setting.

Qualifications

• 2–5 years of experience in GMP/biopharmaceutical environments or CSV-related roles.
• Experience in validation and qualification activities (FAT/SAT) and risk assessments.
• Strong understanding of process controls, instrumentation, and utility systems.

Responsibilities

• Develop engineering documentation (URS, design specs such as FS/HDS/SDS).
• Produce deliverables and documentation for BMS/EMS/ELVS and Automation System.
• Perform testing, commissioning (FAT/SAT) and qualification of BMS/EMS/ELVS and process control systems.
• Apply knowledge of regulatory guidelines (FDA, ICH, ISO) for GMP environments.
• Develop SOPs, change control, deviations, CAPAs, root cause analysis, and investigation.
• Create traceability matrices, GAP analyses, and final reports.
• Lead projects and coordinate contractors and junior staff to drive results.
• Collaborate with Systems Integrators, automation leads, HVAC and process leads.

Skills

PLCs

SCADA

DCS

Data Historians

OPC

BMS/EMS Instruments

CAV/VAV

DDC Controllers

Communication

Time Management

Tools

Honeywell

Siemens

Johnson Controls

Carrier

Rockwell

Schneider Electric

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.
• 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.