Senior Manager - Engineering (Sterile Block Lead)
Sun Pharmaceutical Industries Ltd Halol, Gujarat, India
Pharmaceutical Manufacturing · 10,001+ employees
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About the role
The Senior Manager will oversee the operational management of sterile facility layouts, aseptic processing lines, and clean utility infrastructure. They are responsible for ensuring regulatory compliance, driving operational excellence, and leading cross-functional teams to maintain high-quality production standards.
What they look for
Requirements
Candidates must possess a Bachelor's degree in Engineering and have over 15 years of relevant experience in sterile manufacturing environments. Strong expertise in cGMP, isolator technology, and regulatory audit management is essential for this role.
Benefits
Full description
Job Title:
Senior Manager – Engineering (Sterile Block Lead)
Business Unit:
Sun Global Operations
Job Grade
Senior Manager
Location:
Halol 1
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
1. Facility Layout & Flow: Expert knowledge of cGMP sterile facility layout design, Grade A–D airlocks, pressure differential cascades, and personnel/material flow segregation.
2. Sterile Processing Skids: Direct operational ownership of automated compounding/formulation skids, CIP/SIP (Clean/Steam-In-Place) systems, sterile filtration, and integrity testing.
3. Isolator & RABS Technology: Deep expertise in Barrier Isolators (vHP decontamination, glove leak testing, leak rate validation) and RABS (oRABS/cRABS) for aseptic processing lines.
4. Fill-Finish Machinery: Hands-on experience with high-speed vial filling lines, ampoules, BFS technology, and integrated lyophilizer auto-loading/unloading systems.
5. Clean Utilities & HVAC Infrastructure
6. HVAC & Environmental Control: Full oversight of Unidirectional Airflow (LAF) systems, H14-grade HEPA filtration, differential pressure regimes, and humidity/temperature control across classified zones.
7. 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).
8. Regulatory Compliance & Quality Systems
Audit Leadership: Proven track record of facing and clearing global
9. Qualification & Validation: Ownership of DQ/IQ/OQ/PQ for equipment, media fills (Aseptic Process Simulation), thermal validation, and CSV / 21 CFR Part 11 compliance.
10. QMS Governance: Hands-on control over Deviations, OOS/OOT investigations, CAPA execution, and Change Control Management under EU Annex 1 guidelines.
11. Leadership & Communication
Team Management: Ability to direct, mentor, and build high-performing shift managers, engineers, and production operators.
12. Cross-Functional Synergy: Strong collaboration with Quality Assurance (QA), QC, Engineering, Utilities, and Regulatory Affairs.
13. Executive Communication: Excellent verbal and written English communication skills for external auditor interactions and executive reporting.
14. 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!
Disclaimer: 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).
