Site engineering head

Job Title: Site Engineering Head - Vaccine Drug Substance Plant Location: LALRU
Job Type: Full-Time
Department: Engineering
Reports To: Head of Engineering
Job Summary:
We are seeking an experienced and highly motivated Site Engineering Head with the following objectives:
Oversee all facilities and utilities to ensure a safe and compliant plant for manufacturing of quality products as per regulatory requirements.
Develop, implement and track equipment maintenance, and processes ensuring they are completed on time.
Ensure facilities and systems to meet the global standard.
Identifying opportunities for automation, executing automation projects and ensuring that all validations are completed to the highest standards.
Ensure ethics and compliance
Role:
Demonstrate Comprehensive leadership and management of Good Engineering Practices (GEP)
Demonstrate Knowledge Vaccine machinery, process machinery and equipment along with standard utility equipment like Boilers, compressors, HVAC system, water treatment plants: both working principles and maintenance work.
Apply principles of GMP, quality systems and documentation to engineering department
Design & demonstrate strong and visible support for the GEP and ensure its implementation across all manufacturing sites.
Lead and build Empowered Engineering & Maintenance (E&M) Teams and provide them continuous support in achieving quality output.
Oversee the Engineering and Maintenance operations and review.
To ensure that Plant & machinery delivers consistent performance throughout the production cycles. Plan the Engineering strategies to improve plant performance & deliver right product at right time & at right cost.
Lead and manage IOQ (Installation and Operational Qualification) of equipment’s as a part of New Project implementation.
New technology assessment, equipment retirement and disposal & transfer of Assets.
Key Responsibilities:
Technical:
Wide range of knowledge and experiences of engineering- building, facility, and equipment, and deep and broad GMP knowledge with rich experience of facing regulatory audits like USFDA and WHO.
Basic engineering knowledge of electrical, electronics, instrumentation ,mechanical, automation, building service (HVAC/utility), IT and so on
Basic knowledge of sterile manufacturing/ filling, biologics and vaccine production processes – drug substance, inspection and packaging.
Leadership:
Provide technical resolution to plant manufacturing problems on a timely basis with appropriate urgency
Demonstrate experienced leadership, coaching, guidance and direction to each function of Engineering across multiple manufacturing blocks at Lalru Site.
Develop and lead a diverse organization for Engineering
Lead strategic change for Engineering with excellent communication and team building skills
Decision-making:
Make financial & functional decisions to positively impact both short & long-term site goals
Establish goals and milestones to lead and direct the team breaking down to tactical goal setting in line with superior strategies and policies of Engineering
Innovation:
Encourage sharing and applying best practices and expertise with the team.
Identify and implement strategic opportunities to drive cost reductions / process improvements in manufacturing operations
Develop and maintain a comprehensive GMP facilities master plan to optimize resources
Lead and engage team members with the AGILE program to drive continuous improvements
Complexity:
Coordinate engineering strategic matters with Manufacturing Sites and Site Quality Heads.
Collaborate with cross functional leaders to identify and prioritize facilities and equipment requirements for manufacturing and research and development.
Risk Management:
Identify potential engineering risks and develop mitigation strategies.
Ensure compliance with industry standards and safety regulations, particularly within a Sterile and Biotechnology manufacturing context.
Quality Control & Compliance:
Oversee the testing and validation of manufacturing equipment’s and programs to ensure they meet performance and quality standards.
Ensure that all automation solutions comply with FDA, GMP, and other relevant regulatory requirements.
Documentation & Reporting:
Maintain comprehensive engineering documentation, including plans, progress reports, change requests, and final engineering deliverables.
Regularly report on Plant engineering status to senior management and stakeholders, highlighting key milestones, risks, and outcomes.
Continuous Improvement:
Drive continuous improvement initiatives related to Engineering
Stay current with emerging trends and technologies in engineering, maintenance and automation of sterile manufacturing and Biotechnology manufacturing context.
Energy Management System :
Follow the energy management guidelines & systems and conduct energy Internal Audit, Action plan and compliance.
Develop a program of energy-saving projects & measure, verify the savings achieved.
Identifying and implementation of Energy Saving Measures at manufacturing plant level. Adhering to Energy Management System SOPs and related documents.
Qualifications:
B. Tech / M. Tech in Mechanical Engineering/ Instrumentation and Electronics Engineering/ Automation Engineering / Process Engineering.
Experience:
At least 20 years experiences of engineering in running plants of Biotech industry / Bio- pharmaceutical including at least five years in first line management and second line management positions within a manufacturing environment.
Experience in complex engineering environment and leadership experience for the management of internal and external resources
Proven track record of successfully delivering complex engineering solutions with less down time of the plant.
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