Senior Manager - Engineering (Sterile Block Lead)

SUN PHARMA; Panchmahal District; Sur place; INR 3 000 000 - 6 000 000; Plein temps

Résumé du poste

Sun Pharma Halol invites a Senior Manager – Engineering (Sterile Block Lead) to lead the sterile manufacturing and facility compliance in a high‑risk, cGMP environment. You will own the design, qualification, and ongoing operation of sterile filling lines, isolators, RABS, and clean utilities, ensuring quality and regulatory alignment.

The role requires 15+ years in sterile pharma engineering, BE/BTech, and strong leadership to mentor shift engineers and production operators while driving OEE,

Qualifications

• BE/BTech degree required.
• 15+ years of experience in engineering for sterile pharmaceutical manufacturing.
• Strong leadership and cross-functional collaboration skills.

Responsabilités

• Facility Layout & Flow design for sterile facility (Grade A–D airlocks, pressure cascades).
• Ownership of CIP/SIP systems, sterile filtration, and integrity testing.
• Expertise in Isolators and RABS for aseptic processing lines.
• Hands-on experience with fill-finish machinery and lyophilizer unload/load systems.
• Oversight of HVAC, clean utilities, water systems, and environmental control.
• Regulatory compliance, QA/QC, and 21 CFR Part 11 CSV/validation.
• Lead and mentor shift engineers, production operators, and managers.

Connaissances

Sterile processing

cGMP knowledge

Aseptic processing

Executive communication

Formation

BE /B Tech.

Description du poste

Senior Manager – Engineering (Sterile Block Lead)

Business Unit: Sun Global Operations

Job Grade: Senior Manager

Location: Halol 1

Key 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

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.

Team Management

Ability to direct, mentor, and build high-performing shift managers, engineers, and production operators.

• Cross-Functional Synergy: Strong 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

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).