Site Manager

Responsibilities



Facility & EHS Management:

• Manage the overall site operations, ensuring smooth and efficient functioning of facilities, maintenance, and infrastructure.
• Implement and uphold EHS policies and standards, ensuring full compliance with regulatory requirements and fostering a culture of safety and environmental responsibility.
• Manage proper waste disposal practices, including hazardous waste, ensuring compliance with environmental regulations and internal sustainability goals.
• Liaise with external service providers, contractors, and regulatory bodies to ensure high-quality facility management while maintaining global compliance.
• Manage engineering maintenance teams, ensuring preventive maintenance for cleanroom machinery and equipment, including WFI and Bioreactor systems.
• Write and update maintenance procedures in the plant’s information system.
• Coach and guide project teams, including sub-contractors, maintenance engineers, and commissioning engineers, throughout full project lifecycles.
• Assist with and update preventive maintenance programs to ensure optimal functioning of equipment and facilities.
• Oversee tenant services, monitor KPIs, and ensure service levels align with business unit needs.
• Develop and execute annual maintenance and project plans, ensuring compliance with insurance policies and regulatory requirements.
• Ensure compliance with safety regulations and required standards, including SOPs, CAPA, HACCP, ISO 9001, and MGL.
• Supervise site employees, contractors, and service providers, fostering collaboration with internal stakeholders to meet service needs.
• Manage various operational areas including business licenses, permits (fire, toxic, etc.), janitorial and security services, business continuity, pest control, waste disposal, and site insurance.
• Lead EHS management strategies, driving sustainability initiatives across the site.

Process Scale-Up & Validation:

• Lead process validation and scale-up activities, transitioning R&D projects from lab-scale to pilot and production scale.
• Manage the implementation of scalable production processes, ensuring alignment with cost reduction, process efficiency, and quality standards.
• Develop and oversee process documentation, including protocols and validation reports, ensuring processes are optimized for commercial production.

Technology Transfer:

• Coordinate the transfer of technology and processes from R&D to pilot and production facilities, both locally and globally.
• Ensure that data integrity, process consistency, and operational efficiency are maintained throughout the transfer.
• Collaborate with cross-functional teams to support seamless technology implementation and process improvements.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, or a related field. A Master's degree is a plus.
• 5+ years of experience in process validation, scale-up, or technology transfer in a manufacturing or R&D environment, preferably in biotech or pharmaceutical industries.
• Proven experience in managing cross-functional teams, including maintenance or engineering personnel.
• Strong knowledge of process validation principles, with a focus on scaling R&D projects to pilot and production scales.
• Solid understanding of environmental, health, and safety (EHS) regulations and best practices, with experience leading safety initiatives and ensuring compliance.
• Familiarity with cleanroom environments, bioreactors, and critical manufacturing equipment.
• Excellent project management and organizational skills, with the ability to manage multiple priorities and meet deadlines.
•  Strong problem-solving skills and a continuous improvement mindset, with the ability to optimize processes for efficiency and cost-effectiveness.
• Excellent communication and interpersonal skills to effectively collaborate with internal teams and external partners