Sr.Executive/Asst.Manager– Engineering, Sterile Injectables (CMO)-SEZ

Shantha Biologics Private Limited; Hyderabad; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Shantha Biologics Private Limited in Hyderabad seeks an experienced engineer to own the lifecycle management of aseptic manufacturing equipment, including formulation, filling, and inspection systems. You will drive maintenance, reliability, and upgrades to meet production targets.

The role requires 8–12 years in pharma engineering, with hands-on experience on Syntegon/Bosch filling lines, AVI systems, and formulation equipment, ensuring regulatory compliance and high equipment availability.

Qualifications

• BE/BTech in Mechanical or Electrical engineering.
• 8–12 years of pharmaceutical engineering experience.
• Strong experience with sterile injectables and CMO/CDMO environments.
• Hands-on with filling systems, AVI, and formulation equipment.

Responsibilities

• Own the engineering performance, reliability, and lifecycle management of aseptic manufacturing systems.
• Perform preventive, corrective, and predictive maintenance to minimize downtime.
• Lead troubleshooting of mechanical, instrumentation, and process-related failures.
• Support qualification, requalification, and change controls.
• Drive OEE improvements and ensure regulatory compliance.

Skills

Equipment maintenance

Troubleshooting

OEE awareness

Automation & instrumentation

Regulatory compliance

Education

BE/BTech in Mechanical/ Electrical engineering

Tools

Syntegon/Bosch filling systems

AVI systems

Sartorius formulation equipment

Fedegari Autoclave & Part washers

SCADA systems

SAP PM module

Advanced Excel for performance tracking

eQMS / EDMS exposure

Job description

Position Title:

Department:

Location:

Muppireddipally, Hyderabad

Experience:

8–12 Years

Reports To:

Lead – Process Engineering

Mandate

Own the engineering performance, reliability, and lifecycle management of critical aseptic manufacturing systems—formulation (Sartorius), filling (Cartridge filling), and inspection

(e-Sai/Syntegon AVI)— by performing preventive, corrective, and predictive maintenance activities, minimizing downtime, and supporting production targets, also ensuring high equipment availability, validated state, and regulatory compliance.

What you will own

Equipment Ownership – Filling (Syntegon MLD)

• Ensure reliable operation and uptime of filling lines (Cartridges)
• Own:
  • Equipment performance (OEE, breakdowns, micro-stoppages)
  • Change parts readiness and mechanical integrity
• Lead:
  • Troubleshooting of mechanical/Instrumentation, pneumatic, and process-related failures
• Support:
  • Installation, commissioning, qualification (IQ/OQ/PQ), and upgrades

Equipment Ownership – Visual Inspection (AVI)

• Own AVI system performance and reliability
• Manage:
  • Mechanical setups (star wheels, guides, spacers)
  • Change parts lifecycle and OEM coordination.
  • Instrumentation & Mechanical trouble shooting
• Ensure:
  • Stable operation with minimal downtime and optimal throughput
• Support:
  • Qualification and requalification activities
• Own engineering performance of formulation systems integrated with PCS 7
• Ensure:
  • Equipment reliability (mixing, transfer, filtration systems)
  • Automation integrity (recipes, interlocks, alarms)
• Lead:
  • Troubleshooting of issues
• Support:
  • System upgrades, modifications, and change controls

Maintenance & Reliability Engineering

• Execute:
  • Execute preventive maintenance schedules as per OEM/manual.
• Drive:
  • Breakdown reduction and reliability improvement initiatives
• Maintain:
  • Critical spares strategy and inventory optimization
• Ensure:
  • Minimal downtime and high equipment availability

Qualification & Compliance

• Support and execute:
  • Equipment qualification (IQ/OQ/PQ)
  • Requalification and periodic review
• Ensure systems remain in a validated and audit‑ready state
• Align with:
  • EU GMP Annex 1
  • USFDA and global regulatory expectations

Deviation, Change Control & CAPA

• Engineering investigations for:
  • Equipment‑related deviations and failures
• Perform:
  • Root Cause Analysis (RCA) and implement CAPA
• Support:
  • Change control execution (modifications, upgrades, software changes)

Risk & Continuity Management

• Implement supply risk management strategies (dual sourcing, safety stock, alternate vendors)
• Drive FMEA‑based risk assessments across supply chain operations
• Ensure business continuity plans are in place for critical materials

Stakeholder & Client Leadership

• Collaborate with Manufacturing, QA/QC, utility‑engineering, and Procurement
• Interface with global clients for supply planning and commitments
• Drive governance, reporting, and KPI tracking
• Act as single point of accountability for customers
• Lead governance forums, steering reviews, and executive updates
• Build trust through data‑driven, transparent communication

You bring

• 8–12 years in pharmaceutical industry
• Strong experience in sterile injectables (preferred)
• Exposure to CMO/CDMO environment (highly preferred)
• Process Equipment maintenance & troubleshooting
• Report and mitigate potential failures
• Inventory & Cost Management
• Strong understanding of cGMP, EU Annex 1, SEZ operations and regulatory expectations

Who you are

• 8–12 years in pharma engineering (sterile injectables preferred)
• Qualification: BE/BTech in Mechanical/ Electrical engineering
• Hands‑on experience with:
  • Syntegon/Bosch filling systems with Isolator technology
  • AVI systems (e-sai/syntegon or equivalent)
  • Sartorius formulation equipment
  • Fedegari Autoclave & Part washers
• Strong knowledge of:
  • Mechanical systems, pneumatics, instrumentation, and automation
• Understanding of:
  • EU GMP Annex 1, cGMP, and validation lifecycle

Tools & Systems

• SCADA systems
• SAP PM module (preferred)
• Advanced Excel for performance tracking
• eQMS / EDMS exposure

What sets you apart

• Strong equipment ownership mindset
• Ability to diagnose complex engineering failures
• Balance between compliance and operational efficiency
• Strong collaboration with Manufacturing, QA, and Automation teams

Success in this role (first 12 months)

• Improved OEE and reduction in breakdowns
• Stable, validated performance of MLD, AVI, and formulation systems
• Timely execution of qualification and requalification activities
• Reduced engineering‑related deviations and downtime

Why this role matters

Own and enhance critical aseptic manufacturing equipment with high engineering visibility and exposure to global pharma operations