Company Overview:
Prestige Biologics Co., Ltd is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercialization.
Responsibilities:
The Engineering Manager provides essential technical support to the manufacturing site's engineering and maintenance team in Korea, ensuring seamless operations. The role also involves leading the implementation of engineering best practices and serving as the main point of contact for internal and external stakeholders on all engineering-related matters.
- Oversee and ensure efficient site engineering operations while maintaining full compliance with regulatory requirements.
- Provide leadership and management for the Engineering & Maintenance functions, including automation, projects, utilities, calibration, maintenance, and process engineering.
- Evaluate and implement robust engineering practices, such as predictive maintenance and reliability engineering programs.
- Offer technical expertise in the design, implementation, maintenance, and optimization of manufacturing systems, equipment, and processes. This includes developing User Requirement Specifications (URS) and participating in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and validation processes. A strong understanding of Good Manufacturing Practices (GMP) and industry standards related to pharmaceutical production is essential.
- Lead engineering projects with effective project management skills, focusing on facility upgrades, expansions, and the introduction of new equipment or technologies.
Requirements:
Versatile with strong technical expertise in engineering disciplines such as utilities operation, automation, process engineering, calibration, and maintenance.
- Minimum of a bachelor's or master's degree in an engineering or science-related field.
- At least 7-10 years of experience in engineering, maintenance and project management within the pharmaceutical industry.
- Exceptional critical thinking skills with the ability to prioritize effectively.
- Strong problem-solving and decision-making abilities.
- Proven leadership and management capabilities.
- Adaptable, flexible, and collaborative, with a high comfort level in managing change.
- Excellent communication skills with the ability to inspire and motivate teams.
- Demonstrated track record of delivering results.
