Company Overview

Recruitment.

Job Description

We have the following career opportunity with one of our Pharma / Biotech client: Job Title: Head of Engineering, Maintenance & Projects – Biological Industry (Vaccine Manufacturing) Location: Bhubaneswar, India Reports to: Site Director or President - Operations Position Summary: The Head of Engineering, Maintenance & Projects is a senior leadership role responsible for overseeing engineering, maintenance, automation, and project management functions within a vaccine manufacturing facility. This role is integral to ensuring the continuous, compliant, and efficient operation of critical equipment, such as vessels, fermenters, filling lines, lyophilizer, isolator technology, and associated systems. The ideal candidate brings 25+ years of experience in Injectable, biologics or vaccine manufacturing with deep expertise in GMP documentation, utility systems, and automated process equipment. This leader will drive operational excellence, regulatory compliance, and cross-functional collaboration, playing a crucial role in the facility's success. Key Responsibilities: • Engineering Leadership & Strategic Planning: o Develop and implement engineering and maintenance strategies that align with the facility’s production goals, regulatory requirements, and GMP standards. o Lead engineering and maintenance teams in troubleshooting, maintaining, and optimizing process equipment and automation systems, ensuring maximum uptime and reliability. o Provide expertise in the installation, commissioning, and validation of equipment, including vessels, fermenters, filling lines, lyophilizers, isolators, and automation systems (Siemens, Truking). • Project Management & Equipment Commissioning: o Oversee all capital projects, including facility expansions, equipment upgrades, and infrastructure improvements. o Manage installation and commissioning of critical process equipment, ensuring adherence to project timelines, budgets, and quality standards. o Collaborate with cross-functional teams on project planning and execution, ensuring smooth handover and integration of new equipment into manufacturing. • Automation & Process Equipment Engineering: o Lead automation initiatives, ensuring seamless integration and functionality of process equipment with Siemens, Truking, and other control systems. o Troubleshoot and optimize automated systems, including isolator technology, lyophilizers, and filling lines, to support efficient and reliable production processes. o Drive the adoption of industry best practices in process automation, control systems, and data analytics to enhance operational efficiency. • Utilities & Facility Management: o Manage and ensure the reliability of critical utility systems, including electrical, HVAC, water systems (WFI, RO, purified water), EMS, BMS, and ELV. o Oversee the maintenance of safety and emergency systems to guarantee a safe working environment and compliance with health and safety standards. o Ensure efficient use of resources and energy, implementing improvements to minimize waste and reduce operational costs. • GMP Documentation & Regulatory Compliance: o Oversee all GMP documentation and ensure full compliance with FDA, EMA, and other regulatory standards. o Maintain accurate, up-to-date records for equipment installation, maintenance, and validation activities, preparing the facility for inspections and audits. o Work closely with the Quality Assurance team to support regulatory submissions, validations, and ongoing compliance efforts. • Cross-functional Collaboration & Team Leadership: o Lead and mentor the engineering, maintenance, and project teams, fostering a culture of continuous improvement, safety, and accountability. o Drive inter-departmental collaboration with Quality, Production, and Regulatory Affairs to support the facility’s operational and regulatory needs. o Facilitate knowledge sharing and cross-training to develop a skilled and adaptable workforce capable of supporting the facility’s growth and technology advancements. • Continuous Improvement & Risk Management: o Identify opportunities to improve reliability, efficiency, and performance of equipment and utility systems through innovation and process optimization. o Implement a proactive approach to risk management by identifying potential equipment and operational risks, developing mitigation plans, and implementing corrective actions. o Lead continuous improvement projects in areas such as energy management, automation, and equipment reliability to support cost-effective operations. Qualifications: • Education: Bachelor’s or Master’s degree in Mechanical, Electrical, or Chemical Engineering, or related field. • Experience: o 25+ years of experience in engineering, maintenance, and project management within biologics or vaccine manufacturing. o Demonstrated expertise in installation, commissioning, and troubleshooting of process equipment such as vessels, fermenters, filling lines, lyophilizers, and isolators. o Proven experience with automation systems, including Siemens, Truking, EMS/BMS integration, and advanced troubleshooting of process equipment. • Technical Knowledge: o Strong understanding of GMP, FDA, EMA, and regulatory standards relevant to vaccine manufacturing. o Proficiency in managing utility systems (HVAC, water systems, electrical, safety systems) and associated regulatory documentation. o Skilled in CMMS (Computerized Maintenance Management Systems), project management tools, and automation technologies. • Project Management Skills: Proven experience managing large, complex capital projects, with expertise in budgeting, scheduling, resource allocation, and risk assessment. • Leadership & Collaboration: Strong leadership skills with a track record of building, managing, and mentoring high-performing teams in a collaborative, cross-functional environment. • Problem-solving & Decision-making: Analytical and strategic thinker with the ability to make data-driven decisions, solve complex technical problems, and optimize engineering operations. .

Required Exp

Less than one year yrs

Skill Required

The Head of Engineering, Maintenance & Projects is a senior leadership role responsible for overseeing engineering, maintenance, automation, and project management functions within a vaccine manufacturing facility. This role is integral to ensuring the co

Job Location

Bhuvaneshwar, India

Salary Package

$ 50LPA

Date of Job Posting

2024-12-06 14:33:21

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