Engineering Site Lead – Drug Product Facility

Biological E. Limited; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Biological E. Limited invites applications for an Engineering Site Lead at our Drug Product facility in Hyderabad.

You will lead the entire engineering and maintenance function within a Vaccine MFG/CDMO environment, ensuring reliable, compliant operations across DP processes and utilities. The role owns asset reliability, GMP compliance, and expansion project delivery, and will build a large multi-disciplinary team, driving a world-class maintenance culture and close collaboration with

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Electrical, Instrumentation, or Chemical Engineering.
• 15-20+ years of pharmaceutical/biopharma/vaccine engineering experience, with sterile/aseptic DP facilities exposure.
• Proven track record leading large engineering teams and building world-class maintenance systems.
• Strong knowledge of GMP, qualification/validation, sterile-manufacturing utilities, and regulatory audits.

Responsibilities

• Lead a large, multi-disciplinary engineering organization across processes, disciplines, and shifts.
• Establish and drive a world-class maintenance system (preventive, predictive, RBI/RCM, TPM, CMMS).
• Ensure all engineering activities meet cGMP, data integrity, and regulatory expectations; own qualification/validation lifecycle and change control.
• Plan and deliver site expansion and upgrade projects on time and within budget.
• Ensure uninterrupted operation of all clean/black utilities and controlled cleanrooms; drive energy efficiency.
• Embed a strong safety culture; own site engineering opex and capex budgets and cost optimization.
• Represent engineering in client reviews, audits, and cross-functional leadership interactions.

Skills

Leadership

GMP Compliance

Maintenance & Reliability

Project Management

Regulatory Audits

Budget & Cost Control

Team Building

Lifecycle Management

Education

Bachelor’s/Master’s in Mechanical/Electrical/Instrumentation/Chemical Engineering

Job description

Position Title : Engineering Site Lead - Drug Product Facility

Reports To : Head of Engineering - Vaccines Business Vertical

Facility Type : Drug Product (DP) manufacturing - supporting CDMO operations

Areas of Scope

Formulation, Filling, Packing, Warehouse, QC, Utilities etc

Team

Large, multi-disciplinary engineering & maintenance organization

Role Purpose

Lead the complete engineering and maintenance function for a Drug Product (DP) manufacturing site operating within a Vaccine MFG /CDMO environment, ensuring reliable, compliant, and cost-effective operation of all process areas and utilities. The role owns asset reliability, GMP engineering compliance, expansion project delivery, and the development of a large multi-disciplinary engineering team, with the mandate to build a world-class maintenance culture that consistently meets client, quality, and regulatory expectations.

Scope of Responsibility

The role provides engineering leadership and maintenance support across the full DP value chain and site infrastructure:

• Process & support areas: formulation, aseptic/sterile filling, packing, warehouse, QC laboratories, and the complete utilities envelope.
• Utilities: HVAC and cleanrooms, purified water / WFI, clean steam, compressed air and process gases, chilled water, BMS/EMS, and power distribution.
• Projects: engineering scope on capital projects is limited to expansion projects (capacity additions, line/area upgrades, and de-bottlenecking) rather than new greenfield facility builds.

Key Responsibilities

Maintenance & Asset Reliability

• Establish and drive a world-class maintenance system built on preventive, predictive, and reliability-centered maintenance (RCM), TPM, and a mature CMMS.
• Improve equipment reliability, OEE, and MTBF/MTTR; minimize unplanned downtime and breakdowns.
• Own spares strategy, criticality analysis, and asset lifecycle / obsolescence management for all critical equipment.

GMP Compliance & Quality

• Ensure all engineering activities meet cGMP, data integrity, and regulatory expectations (USFDA, EMA, WHO, and other applicable agencies).
• Own the qualification and validation lifecycle (URS, DQ/IQ/OQ/PQ), calibration, change control, and computerized system compliance.
• Lead engineering readiness for regulatory, corporate, and client/CDMO audits; own and close engineering CAPAs on time.

Expansion Projects & Engineering

• Plan and deliver site expansion and upgrade projects on time, within budget, and to defined quality and compliance standards.
• Manage design, procurement, commissioning, qualification, and handover in coordination with global engineering, project, and client teams.

Utilities & Facilities

• Ensure uninterrupted, qualified operation of all clean and black utilities and controlled cleanroom environments.
• Drive energy efficiency, sustainability, and utility cost optimization.

EHS, Budget & Cost

• Embed a strong safety culture; ensure compliance with EHS regulations, permit-to-work systems, and risk assessments.
• Own the site engineering opex and capex budgets; drive cost optimization without compromising compliance or reliability.

Leadership Responsibilities

• Lead a large, multi-disciplinary engineering organization across process areas, disciplines, and shifts.
• Build capability through structured training, succession planning, and talent development; grow future engineering leaders.
• Set direction, KPIs, and performance standards; foster accountability, ownership, and a continuous-improvement mindset.
• Act as the site's senior engineering leader and a key member of the site leadership team.

Stakeholder Management

• Serve as the primary engineering interface for internal customers / CDMO clients on technical, reliability, and project matters, building trust and credibility.
• Partner closely with Production, Quality, Supply Chain, Projects, and EHS to align engineering priorities with site and business goals.
• Manage relationships with the engineering function, OEMs, contractors, and service providers.
• Represent engineering in client reviews, audits, and business meetings; communicate clearly across technical and leadership audiences.

Qualifications & Experience

• Bachelor's / Master's degree in Mechanical, Electrical, Instrumentation, or Chemical Engineering.
• 15-20+ years of pharmaceutical / biopharma / vaccine engineering experience, with significant exposure to sterile/aseptic DP facilities.
• Proven track record of leading large engineering teams and building world-class maintenance systems.
• Strong knowledge of GMP, qualification/validation, sterile-manufacturing utilities, and regulatory audits.
• Experience in a CDMO or client-facing manufacturing environment strongly preferred.
• Demonstrated success in delivering expansion / upgrade capital projects and driving reliability improvement.

Strategic and hands-on engineering leadership; reliability and TPM mindset; regulatory and quality orientation; project management; financial acumen; excellent stakeholder and client management; and the ability to drive cultural change at scale.