Sterile Engineer Unit Level at Indore

Sterile Engineer Unit Level

Location: Indore

Experience Required: 1015 years in sterile process engineering (Pharma/Biotech)

Education: BE/B.Tech in Mechanical or Chemical Engineering

Role Purpose

The Sterile Engineer plays a pivotal role in supporting Unit Engineering and Operations by enhancing asset reliability, optimizing maintenance strategies, and ensuring maximum equipment and area availability with minimal downtime. This role demands technical leadership in asset design, qualification, and validation, with a strong emphasis on regulatory compliance, investigation excellence, and capability building across sterile operations.

Key Responsibilities

1. Asset Design & Reliability

• Evaluate reliability of critical sterile equipment: autoclaves, lyophilizers, ALUS, filling/capping machines, tunnel sterilizers, DHS, water systems, HVAC.
• Lead facility design, qualification, and maintenance aligned with cGMP and regulatory standards.
• Implement and maintain GMP-compliant monitoring systems (e.g., BMS).
• Validate and optimize sterile processing, CIP/SIP cycles, and smoke study reviews.
• Collaborate on HVAC qualification and water system failure analysis.
• Review and revise BFDs, PFDs, and P&IDs for utilities and layouts.
• Mentor junior engineers and operators; troubleshoot technical issues.
• Ensure aseptic practices and gowning compliance.

2. Equipment & Area Qualification

• Lead installation, commissioning, and validation (IQ/OQ/PQ) of sterile equipment.
• Champion Right First Time validation strategies.
• Refine validation protocols and support CAPA definition.
• Validate cleanroom SOPs, CIP/SIP, and VHP cycles.
• Deploy advanced validation tools for efficiency and compliance.

3. Engineering Solutions Right First Time

• Guide structured investigations into equipment/process failures.
• Conduct root cause analyses and elevate investigation report quality.
• Provide technical support for process troubleshooting and CAPA closure.

4. Compliance & Regulatory Readiness

• Ensure alignment with cGMP and evolving sterility standards.
• Develop engineering controls and process monitoring systems.
• Lead audit readiness, documentation accuracy, and regulatory responses.
• Serve as SME for inspections and compliance reviews.

5. Utilities Oversight

• Ensure quality and compliance of critical utilities: water, HVAC, gases.
• Lead inspections and predictive monitoring for utility systems.
• Investigate failures and implement corrective strategies.

6. Capability Building & Innovation

• Introduce emerging technologies (Isolators, SCADA, DCS, IIoT) to enhance sterile operations.
• Define vendor quality criteria and manage spare part reliability.
• Train teams on sterile protocols and safety standards.
• Lead cross-functional projects for process improvement and cost/time optimization.

Major Challenges

• Legacy assets and obsolete technologies vs. modern CGMP expectations.
• Rapid regulatory shifts in qualification and validation.
• Integration of advanced tech platforms (IT/OT/SCADA/IIoT).
• Addressing 483 observations across sterile facilities.
• Strengthening investigation quality and CAPA effectiveness.
• Talent retention and capability enhancement.

Key Stakeholder Interactions

• Internal: EM&R,AI&R, Safety, Site/Unit Heads, Indirect & Central Purchase, Manufacturing Teams.
• External: OEMs, automation partners, alternate vendors, consultants.

Dimensions & Impact

• Team Leadership: ~12 dotted-line reports across Manufacturing and EM&R.
• Zero major failures in asset integrity or HVAC validation.
• Strategic decisions on system design, compliance gaps, vendor selection, and consultant hiring.