Location: Suzhou, China
Position Type: Fixed-Term
Job Function: Manufacturing
PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
1.Participate in the MSO2.0 Suzhou Project as the Production equipment Engineer and provide knowledge and experience during different project implementation phases.
2.Organize and coordinate the assigned work and provide efficient and cost effective Operation and maintenance services.
3.Set up and maintain the operation & maintenance management system for production equipment and make sure that all Biomerieux Global directives, GEP (Good Engineering Practice) and GMP are fully implemented.
1.Safety, Health & Environment
Ensure that all applicable Safety, Health & Environment requirements are compliant to group policy and local legal requirements.
2.Quality and Compliance
-Collaborate with site quality to make sure Right to operate through compliant to all related regulatory requirements.
-Implement and apply the Biomerieux Quality System.
-Support line manager to control team expenses within the set year budget.
-Seek continuous improvement opportunities to decrease the operation , maintenance cost and energy cost within owned area .
-Participate in the design of Production equipment and provide constructive suggestion & comments.
-Participate in the selection / assessment of Production equipment vendor and related system.
-Keep good communication and alignment with foreign vendors and US engineering team to learn, master and apply to the future operation.
-Participate in the review of all production equipment related document.
-Participate in and lead the Production equipment FAT and SAT.
-Participate in the installation, commissioning qualification and final handover.
-Participate in the construction of Pilot Plant and responsible for the production equipment maintenance
-As the system owner, responsible for the Maintenance of all production equipment –including but not limited to Weighing system, Formulation system, CIP system, COP system, Filling lines, Mixed Gas system，Autoclave system, Packaging Lines, Forklift, , etc.
-Guide team members to maintain these systems including the routine resource arrangement.
-As the System Expert, responsible for system document updating and related issue handling. This includes creating and updating related SOP, re-qualification support, incident handling and management, change management, deviation investigation and handling.
-Evaluate system performance and develop related actions to improve system operational & maintenance & Energy efficiency.
-Ensure in time response to critical alarms in compliance with the SOP and related Quality Procedures. Evaluate the alarm trends and establish corrective actions to avoid repeat events.
-Optimize or upgrade related systems to meet company strategy and/or system requirement.
-Other tasks assigned by line manager.
KNOWLEDGE, LANGUAGE AND EXPERIENCE:
-Bachelor degree (equivalent) or above.
-Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese.
-Chemical Engineering, Pharmaceutical Engineering, Mechanical related background with no less than 5 years of Plant production maintenance experience in IVD or pharmaceutical industry. Familiar with the maintenance of Weighing system, Formulation system, CIP system, COP system, Filling lines, Mixed Gas system，Autoclave system, Packaging Lines, Forklift, , etc.
-Independent technical knowledge regarding to the Preventative and Re-active maintenance, trouble-shooting of site production equipment.
-Prefer to have the Electrician Certificate.
-Experience and Capability in GMP related equipment commissioning, qualification and validation process.
-This position will be based in Shanghai&Suzhou.