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Role Summary: To assure activities that are related to Engineering and Maintenance operations in compliance with Current Good Manufacturing Practice (cGMP) and Good Engineering Practice (GEP) requirements and standards. To establish Engineering Management System for the Guangzhou Site (GZS), and extend it to routine operations after closure of project.
Essential Responsibilities: 1. Manage the Engineering Function in order to provide accurate, compliant and timely support to the project especially with regards to ensuring that activities are in alignment with multi-disciplines in cGxP and Environment, Health, Safety (EHS) to enable future site operations in compliance with applicable regulations and laws. Cooperate with global team and other functional teams on GZS to establish good Engineering Management System which is lean, effective and compliant, so that all Engineering related activities and documentations are adhering to GEP disciplines during project period and future routine operations. 2. Lead, train, motivate and manage the performance of the Engineering team. 3. Guide functional team to complete protocols, reports and SOPs etc, and prepare and approve all Engineering related documents in line with GEP requirements. 4. Responsible for co-ordinating all engineering activities on the site (covering maintenance of plant and facilities, spare parts management, engineering capital project implementation, operation of waste treatment plant, plant calibration system, engineering and facilities contractor management and engineering function input into major projects 5. Ensure Preventive Maintenance plans, systems and procedures be in place and agreed with Planning and Manufacturing to maximize the availability of systems for their intended use. 6. Ensure asset history and traceability be recorded and maintained properly. 7. Prepare budget for Engineering function and activities – human resources, overheads and maintenance. 8. Anticipate and plan for future requirements in the area, including but not limited to, procedural requirements, capital equipment planning, personnel recruitment planning, compliance requirements, efficiency developments and potential changes; reflect future demand for services from the function, and consequently build them in a timely manner in the budgeting process. 9. Set up challenging goals in Engineering function and work towards them jointly with Engineering team and stakeholders; report and check status regularly to keep the set targets reasonable and attainable. 10. Foster an environment of continuous improvement.
Qualifications/Requirements: 1. Bachelor in Sciences as minimum, post-graduate degree and above is preferable. 2. Familiar with multi-disciplines GMP and GEP and relevant drug regulations. 3. Good communicator, collaborative and decisive as a team leader. 4. Skillful in both written and oral English. 5. Minimum 5 years supervisory\\management experience in Engineering of Bio-pharmaceutical or Pharmaceutical Industry essential. 6. Engineering working experience in Bio-pharmaceutical industry is preferable.
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