Senior Manager - Engineering Sterile Block Lead

SUN PHARMA; Panchmahal District; Vor Ort; INR 4.200.000 - 5.600.000; Vollzeit

Zusammenfassung

Sun Pharma is seeking a Senior Manager - Engineering (Sterile Block Lead) for Halol 1. The role requires BE/BTech with 15+ years in sterile manufacturing, overseeing cGMP facility layouts, sterilization, fill-finish lines, and regulatory compliance. Strong leadership, audits, and cross-functional teamwork are essential.

On-site role with opportunities to drive improvements and team development. The incumbent will lead qualification, validation, and QMS governance, ensuring high-quality

Qualifikationen

• Strong leadership and people management skills.
• Ability to drive cross-functional collaboration with QA/QC/Engineering.
• Excellent verbal and written English communication for external audits.

Aufgaben

• Lead sterile block operations and ensure cGMP compliance.
• Oversee validation activities (DQ/IQ/OQ/PQ) for equipment and processes.
• Manage qualification activities for media fills and thermal validation.
• Drive OEE improvements, reduce downtime, and optimize yield.
• Ensure regulatory compliance and QMS governance across shift teams.

Kenntnisse

Leadership

Cross-functional collaboration

English communication

Process improvement

Ausbildung

BE / BTech

Jobbeschreibung

Job 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, pressuredifferential 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
• 12. Team Management: Ability to direct, mentor, and build high-performing shift managers, engineers, and production operators.
• 13. Cross-Functional Synergy: Strong collaboration with Quality Assurance (QA), QC, Engineering, Utilities, and Regulatory Affairs.
• 14. Executive Communication: Excellent verbal and written English communication skills for external auditor interactions and executive reporting.
• 15. Operational Excellence: Driving OEE improvement, downtime reduction, yield optimization, and continuous process improvements.

Travel Estimate: As per business requirement

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).

Requirements: