Senior Manager - Engineering (Sterile Block Lead)

Sun Pharmaceutical Industries Ltd; Panchmahal District; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd invites an accomplished Senior Manager – Engineering (Sterile Block Lead) to lead the sterile manufacturing block in Halol. You will oversee facility layout, steriles systems, isolators/RABS, fill-finish machinery, and clean utilities to ensure compliant, efficient operations.

You will coordinate with QA/QC, Utilities, and Regulatory Affairs, drive continuous improvement, and mentor a high-performing shift team.

Qualifications

• BE /B Tech degree is required.
• 15+ years of experience in engineering roles in pharma/sterile manufacturing.
• Experience leading sterile block facilities and cross-functional teams.

Responsibilities

• Facility Layout & Flow: design sterile facility layouts per cGMP and manage airlocks and flow.
• Sterile Processing Skids: own automated compounding/formulation skids and CIP/SIP systems.
• Isolator & RABS Technology: expertise in barrier isolators and RABS for aseptic processing.
• Fill-Finish Machinery: hands-on with high-speed vial filling lines, BFS tech, lyophilizer loading/unloading.
• Clean Utilities & HVAC Infrastructure: oversee LAF, HEPA filtration, pressure/differential control.
• HVAC & Environmental Control: manage humidity/temperature in classified zones.
• Pure Water Systems: monitor WFI, PW, and PS systems and TOC/endotoxin control.
• Regulatory Compliance & Quality Systems: lead audit readiness and compliance.
• Qualification & Validation: DQ/IQ/OQ/PQ and CSV/21 CFR 11 compliance.
• QMS Governance: manage deviations, CAPA, deviations, and change control per EU Annex 1.
• Leadership & Communication: lead shift managers and engineers with strong communication.
• Cross-Functional Synergy: collaborate with QA, QC, Engineering, Regulatory.
• Executive Communication: report to auditors and executives in English.
• Operational Excellence: drive OEE improvement and process optimization.

Education

BE /B Tech.

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, 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 & 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).