Ideal candidate should have minimum 6 -12 years of experience:
- Design experience mainly in Injectable/sterile process equipment [ Vial lines, filling, autoclave..]
- Experience in AutoCAD
- Hands on experience in greenfield Project Governance & Portfolio Led Conceptual, Basic, and Detailed Engineering activities for multiple high-value CAPEX projects on strategic expansion of injectable and biologics manufacturing capacity.
- Developing conceptual layout (master layout /facility layout), develop CAPEX budget, cost control, schedule forecasting, risk mitigation, and resource optimization for simultaneous multi-crore projects.
- Delivered projects consistently within approved timelines and budgets through structured governance Aseptic, Injectable & Biologics Expertise
- Extensive experience in Sterile Fill-Finish facilities for Vials, Cartridges, and Pre-Filled Syringes (PFS).
- Hands-on leadership in isolator-based filling lines, including high-speed vial lines, cartridge lines& secondary packaging lines.
Specialized in Vaccine, mAbs, and Peptide facilities, including:
- Single-Use Technology (SUT) Bioreactors
- Fermentation facilities for peptide manufacturing
- Delivered BFS projects and Uniject Greenfield facilities Greenfield & Brownfield design & Execution
- Led end-to-end execution of multiple greenfield facilities-from site development and GMP layout design to
mechanical completion, commissioning, qualification, and Utilities & Infrastructure Mastery:
- Designing and coordination for commissioning of Clean Utility systems (PW, WFI, PS) in full compliance with ASME BPE standards.
- Designing and coordination for commissioning of Black Utility generation and distribution systems, including boilers, chillers, compressors, and cooling towers.
5. HVAC & Environmental Designing and coordination for commissioning & qualification HVAC systems up to ISO-5 / Class-A environments for sterile operations.
6. Operational Excellence & Cost Value engineering and strategic vendor negotiations, resulting in significant CAPEX and OPEX savings without compromising quality or compliance.
- Managing complex equipment procurement, installation, commissioning, and integration activities across vendors and packages.
- Experience on resolving critical contamination issues, including elimination of Pseudomonas from pretreatment water systems.
7. Automation & Digital Experience in designing of automation & digitalization systems.
(ref:iimjobs.com)