Site Engineering Head

Job Title:

Location:

Job Type:

Department:

Reports To:

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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