【About the role】
Acepodia seeks a highly motivated and experienced GMP Facility Engineering Manager to join our team. The GMP Facility Engineering Manager plays a crucial role in overseeing the design, maintenance, and operation of our facility and its associated equipment and systems, ensuring compliance with all Good Manufacturing Practices (GMP) regulations. This position demands a strong understanding of engineering principles, GMP guidelines, and project management methodologies, along with excellent leadership and communication skills.
【Position Title】 (Sr.) Manager of GMP Facility Engineering
【Location】 Taipei, Taiwan.
【Reports to】 CTO
【Job Type】 Full-time
【Responsibilities include, but are not limited to】
Project Management & Compliance:
• Develop and implement comprehensive project plans for facility modifications, equipment upgrades, and new installations, including scope, timelines, resources, and budgets.
• Manage the design, planning, construction, and maintenance of buildings, equipment, and other facilities to ensure compliance with GMP regulations.
• Ensure that all engineering projects, initiatives, and processes conform to the organization's established policies and objectives.
• Oversee the equipment, facilities, and utilities validation program, ensuring that all systems meet regulatory requirements and company standards.
• Manage the department's operating budget and contribute to the development of the facility's annual and long-term strategic capital investment plan.
Leadership & Collaboration:
• Lead and actively participate in client interactions regarding equipment, facility, and utility lifecycle management.
• Provide technical expertise and guidance to cross-functional teams, including manufacturing, quality assurance, and validation.
• Manage and supervise third-party contractors and other internal service providers, ensuring that all work is completed according to procedures and health and safety standards.
Maintenance & Continuous Improvement:
• Identify and implement continuous improvement initiatives to optimize the performance and reliability of process equipment, utilities, and facilities.
• Maintain and coordinate engineering maintenance support on off hours, as necessary.
• Manage the calibration program and the Planned Preventative Maintenance program.
Training & Safety:
• Ensure that GMP is adhered to in all areas of work and that all employees understand and follow department objectives, company policies, and procedures.
• Maintain a safe working environment and ensure compliance with all relevant safety regulations.
• Oversee and ensure that all employees undergo GMP training to fully understand their roles and responsibilities in maintaining compliance.
• Documentation & Reporting:
• Contribute to the development and continuous improvement of Standard Operating Procedures (SOPs) and Standard Work Instructions.
• Manage the process for creating SOPs and other documentation for facility equipment maintenance plans, manufacturing equipment maintenance plans, calibration SOPs, and the reliability engineering program.
• Support Commissioning and Validation activities as needed.
• Support Development Engineers and Equipment Vendors in delivering Equipment Turn Over Packages (ETOPs).
• Work closely with all functional departments to ensure the continued maintenance of a validated environment according to cGMP and other regulatory requirements.
• Deliver high-level reporting to directors and other leadership.
• Operational Support:
• Provide a daily presence in manufacturing and facility areas to support operations by troubleshooting and resolving complex technical issues.