Engineering Manager. Engineering & Validation ------JHL Wuhan
Full time management of the engineering and validation avtivities for the global-standard JHL Biotech facilities in Wuhan during the start-up phase and subsequent operation. This function is responsible for:
1. Coordinating design, construction, and start-up activities of the JHL-01 facility.
2. Developing and implementing the systems and team for maintenance, calibration and qualification of the Company facilities, utilities, and process equipment.
3. ctive participation in the development and implementation of the Company Quality Management System with specific responsibility for control of plant and equipment.
4. Leading the site safety initiatives.
5. Setting engineering and validation budget and managing performance to approved budget.
Essential functions include but are not limited to the following:
1. Developing and maintaining a culture of safe working practices through personal leadership and establishing standard procedures for safety management.
2. Enforcing a system for job safety assessments and issuing permits-to-work including lock-out tag-out of energized and hazardous systems.
3. Participation in site safety committee as required.
1. Coordinating preparation of documented User Requirement Specifications.
2. Management of specialist design consultants and liaison with vendors to design and specify systems.
3. Reviewing and approval of design packages for facilities and utilities.
1. Preparing and managing the schedule of preventative maintenance and calibration activities for the site. Priority being core manufacturing facility and utilities and coordination with Production and QC departments.
2. Managing timely response to break-down events.
3. Managing the inventory of critical spare parts to ensure that foreseen mechanical failures of utilities can be rectified within 24 hours.
4. Preparing and managing the programmed maintenance plan for the site covering cleaning and renovation of buildings and grounds to keep them in a high standard.
5. Contributing to investigation of quality investigations related to performance of facility and equipment.
1. Establishing and maintaining the system of testing for facilities, utilities, and equipment based on the JHL Biotech corporate standards.
2. Preparation of the Schedule for validation of facilities and utilities.
3. Coordinating execution of testing with vendors and JHL Biotech personnel.
4. Ensuring that all facilities and utilities used in GxP operations are maintained in their validated state.
1. Recruiting and management Engineering and Validation Staff
2. Selection, approval, and management of preferred contract service providers to perform specialist services and supplement staff resources such as pest control, recurring maintenance support agreements, out-sourced calibration, waste removal, periodic renovation, and maintenance of grounds.
3. Preparation and management of expenditure in line with budget for engineering and validation activities.
4. Preparation of capital expenditure requests for site improvement and renovation projects.
Job Qualifications (Education, Certifications, Experience)
1. B.E. (preferably Mechanical or Chemical) plus a minimum of 10 years responsibility for maintenance of capital assets within pharmaceutical organizations or M.Eng. with at least 7 years or equivalent.
2. Preferably experienced in operation of biopharmaceutical API facilities and exposure to facility start-up.
3. Demonstrated capability and enthusiasm to establish high-performance teams.
4. OTHER KNOWLEDGE AND SKILLS REQUIRED:
o Thorough knowledge of Good Engineering Practices encompassing documentation and operation of pharmaceutical facilities.
o Detailed knowledge of maintenance and calibration management for process utilities and equipment.
o Detailed knowledge of the operation of pharmaceutical utility systems (e.g. PW, WFI, Pure Steam, Compressed Air, HVAC) and general building services (access control, boiler, waste neutralization, chillers, cooling towers, electrical power, emergency generators, compressed gas)
o Sound staff management experience.
o Sound budgeting and financial control experience.
o Understanding of Good Manufacturing Practices.
o Strong computer system and database skills preferably including use of computerized maintenance management systems (CMMS)
o Ability to investigate and solve problems.
o Strong communication skills in English and Chinese to engage with personnel from multiple disciplines and experience bases across the operations organization.