Head of Engineering

Gennova Biopharmaceuticals Limited; Pune District; Vor Ort; INR 4.000.000 - 9.000.000; Vollzeit

Zusammenfassung

Gennova Biopharmaceuticals Limited in Pune District, India, seeks a senior engineering leader to oversee Engineering, Projects, Utilities, Automation, Maintenance, and Reliability across biopharmaceutical manufacturing networks. You will drive asset reliability, regulatory compliance, and capital projects for API and aseptic facilities.

The role requires 20+ years in pharma/biopharma engineering, leadership of large teams, and deep expertise in sterile manufacturing, utilities, and

Qualifikationen

• B.E./B.Tech in Mechanical, Electrical, Instrumentation, Chemical Engineering or related discipline.
• 20+ years of engineering experience in pharmaceutical, biopharmaceutical, biologics, or sterile manufacturing environments.
• Proven leadership of multi-site engineering operations.
• Strong experience in API, biologics/biosimilars, sterile injectables, utilities, automation, and large-scale projects.
• Engineering Leadership
• Reliability & Asset Management
• Sterile Manufacturing Engineering
• Project & CAPEX Management
• Utility Systems
• GMP Compliance
• Operational Excellence
• Strategic Planning & People Leadership

Aufgaben

• Lead Engineering, Projects, Utilities, Automation, Maintenance, and Reliability functions across the organization's biopharmaceutical manufacturing network comprising:
• API Manufacturing Facilities; Aseptic Manufacturing Facilities; Isolator-Based Operations; Lyophilization (Freeze Drying) Facilities.
• The role will drive engineering excellence, regulatory compliance, asset reliability, capacity expansion, operational efficiency, and digital transformation across all sites.
• Provide strategic leadership to all site engineering teams and engineering heads.
• Ensure high equipment reliability, uptime, and engineering compliance across manufacturing facilities.
• Lead maintenance, utilities, calibration, automation, and facility engineering functions.
• Drive capital projects, facility expansions, technology upgrades, and commissioning activities.
• Ensure compliance with GMP and global regulatory requirements (USFDA, EMA, MHRA, WHO).
• Oversee critical utility systems including HVAC, WFI, clean steam, compressed air, electrical, and process utilities.
• Support sterile operations involving aseptic processing, isolators, and lyophilizers.
• Drive operational excellence, energy optimization, sustainability, and cost improvement initiatives.
• Build engineering capability through talent development and succession planning.
• Partner with HR to build a high-performance engineering organization through talent management, succession planning, employee engagement, performance management, and workforce capability building.
• Drive Learning & Development (L&D) initiatives by establishing technical competency frameworks, leadership development programs, certification pathways, and training effectiveness measures for engineering teams.

Kenntnisse

Engineering Leadership

Reliability & Asset Management

Sterile Manufacturing Engineering

Project & CAPEX Management

Utility Systems

GMP Compliance

Operational Excellence

Strategic Planning & People Leadership

Ausbildung

B.E./B.Tech in Mechanical, Electrical, Instrumentation, Chemical Engineering or related discipline

20+ years of engineering experience in pharmaceutical/biopharmaceutical/sterile manufacturing environments

Proven leadership of multi-site engineering operations

Jobbeschreibung

• 20+ years of pharmaceutical/biopharmaceutical engineering experience
• Proven expertise in API, biologics, R&D and sterile manufacturing
• Demonstrated success leading large engineering teams and complex manufacturing networks

Qualification and Experience:

• B.E./B.Tech in Mechanical, Electrical, Instrumentation, Chemical Engineering or related discipline.
• 20+ years of engineering experience in pharmaceutical, biopharmaceutical, biologics, or sterile manufacturing environments.
• Proven leadership of multi-site engineering operations.
• Strong experience in API, biologics/biosimilars, sterile injectables, utilities, automation, and large-scale projects.
• Engineering Leadership
• Reliability & Asset Management
• Sterile Manufacturing Engineering
• Project & CAPEX Management
• Utility Systems
• GMP Compliance
• Operational Excellence
• Strategic Planning & People Leadership

Job Responsibilities

Lead Engineering, Projects, Utilities, Automation, Maintenance, and Reliability functions across the organization's biopharmaceutical manufacturing network comprising:

• API Manufacturing Facilities
• Aseptic Manufacturing Facilities
• Isolator-Based Operations
• Lyophilization (Freeze Drying) Facilities

The role will drive engineering excellence, regulatory compliance, asset reliability, capacity expansion, operational efficiency, and digital transformation across all sites.

• Provide strategic leadership to all site engineering teams and engineering heads.
• Ensure high equipment reliability, uptime, and engineering compliance across manufacturing facilities.
• Lead maintenance, utilities, calibration, automation, and facility engineering functions.
• Drive capital projects, facility expansions, technology upgrades, and commissioning activities.
• Ensure compliance with GMP and global regulatory requirements (USFDA, EMA, MHRA, WHO).
• Oversee critical utility systems including HVAC, WFI, clean steam, compressed air, electrical, and process utilities.
• Support sterile operations involving aseptic processing, isolators, and lyophilizers.
• Drive operational excellence, energy optimization, sustainability, and cost improvement initiatives.
• Build engineering capability through talent development and succession planning.
• Partner with HR to build a high-performance engineering organization through talent management, succession planning, employee engagement, performance management, and workforce capability building.
• Drive Learning & Development (L&D) initiatives by establishing technical competency frameworks, leadership development programs, certification pathways, and training effectiveness measures for engineering teams.