Job Title

Senior Manager - Engineering (Sterile Block Lead)

Business Unit

Sun Global Operations

Job Grade

Senior Manager

Location

Halol

Responsibilities

- Facility Layout & Flow: Expert knowledge of cGMP sterile facility layout design, Grade A-D airlocks, pressure differential cascades, and personnel/material flow segregation.
- Sterile Processing Skids: Direct operational ownership of automated compounding/formulation skids, CIP/SIP (Clean/Steam-In-Place) systems, sterile filtration, and integrity testing.
- Isolator & RABS Technology: Deep expertise in Barrier Isolators (vHP decontamination, glove leak testing, leak rate validation) and RABS (oRABS/cRABS) for aseptic processing lines.
- Fill-Finish Machinery: Hands-on experience with high-speed vial filling lines, ampoules, BFS technology, and integrated lyophilizer auto-loading/unloading systems.
- Clean Utilities & HVAC Infrastructure
- HVAC & Environmental Control: Full oversight of Unidirectional Airflow (LAF) systems, H14-grade HEPA filtration, differential pressure regimes, and humidity/temperature control across classified zones.
- Pure Water Systems: Monitoring and maintenance alignment for high-purity water loops-Water for Injection (WFI), Purified Water (PW), and Pure Steam (PS) generators (TOC, conductivity, endotoxin control).
- Regulatory Compliance & Quality Systems: Audit Leadership:



Proven track record of facing and clearing global audits.
- Qualification & Validation: Ownership of DQ/IQ/OQ/PQ for equipment, media fills (Aseptic Process Simulation), thermal validation, and CSV / 21 CFR Part 11 compliance.
- QMS Governance: Hands-on control over Deviations, OOS/OOT investigations, CAPA execution, and Change Control Management under EU Annex 1 guidelines.
- Leadership & Communication: Team Management: Ability to direct, mentor, and build high-performing shift managers, engineers, and production operators.
- Cross-Functional Synergy: Robust collaboration with Quality Assurance (QA), QC, Engineering, Utilities, and Regulatory Affairs.
- Executive Communication: Excellent verbal and written English communication skills for external auditor interactions and executive reporting.
- Operational Excellence: Driving OEE improvement, downtime reduction, yield optimization, and continuous process improvements.

Travel Estimate

As per business requirement

Job Requirements

- Educational Qualification : BE /B Tech.
- Experience : 15+ years

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Manager - Engineering (Sterile Block Lead) (Kalol)
🏢 SUN PHARMA
📍 Kalol