27 Aug
|
Talental Consultings
|
Karnataka
27 Aug
Talental Consultings
Karnataka
Role Overview
A leading biologics organization seeks an experienced Engineering Lead (DGM/GM) to oversee DS & DP facility , ensuring seamless operations across bioreactors, utilities, HVAC systems, and chromatography suites .
Key Responsibilities
Lead engineering operations for bioreactor systems supporting biologics manufacturing
Manage utilities, HVAC, and cleanroom settings to maintain GMP compliance
Oversee chromatography and downstream purification facilities ensuring process reliability
Drive equipment qualification, validation, and preventive maintenance programs
Collaborate with R&D;, QA/QC, and manufacturing teams for continuous improvement initiatives
Ensure adherence to USFDA, EMA, and other regulated market standards
Implement automation, energy efficiency, and sustainability practices in engineering operations
Candidate Profile
B.E./B.Tech/M.Tech in Mechanical Engineering
18–25 years of experience in biologics/biopharma engineering operations
Robust expertise in bioreactor handling, utilities, HVAC, and chromatography systems, Vial filling, Vial washing, autoclave
Proven track record in regulated biologics facilities (US/EU markets)
Ability to lead cross-functional teams and manage large-scale engineering projects
Job Requirements: Maintenance, Reliability, Bioreactors, Chromatography Systems, TFF, HVAC, Utilities, WFI/PW, Process Equipment, GMP-compliant engineering, Maintenance operations, Plant projects, Compliance, Audits, Team leadership
📌 Head Engineering Biologics Karnataka
🏢 Talental Consultings
📍 Karnataka