REQUIREMENTS

• MS degree or BS degree in Bioengineering/Biotechnology, Chemical Engineering and Food Science and Technology or related field with seven to ten years of bio-industrial experience.
• Experience with biological operations, e.g. fermentation, cell culture, and/or food biotechnology is a must. Familiarity with concepts, such as process design, mass balance, and transfer phenomena.
• Must have working knowledge of various unit operations like fermentation, centrifugation, homogenization, purification, spray drying, and packing etc. Utilities operation experience in running chiller, boiler, air compressor, process water and waste water system, technical maintenance, CIP system operations, and process control are important and good to have.
• Minimum seven years of experience in managing Operations and Maintenance team.
• Experience in collecting and analyzing data from laboratory and pilot plant operations to improve production including yields, rates, mass and energy balances, etc.
• Strong communication skill, skill in computer data analysis and data base management.
• Familiarity with working experience in GMP environment, while cGMP is a plus. Demonstratable knowledge and expertise on aseptic operations and running sterile multi-product operation controls.
• Must be safety conscious and follow safety guidelines including lockout tagout, MSDS, and use of personal protective equipment.
• Experience in supervising and project management a plus

OPERATIONS RESPONSIBILITIES:

• Plan and manage the end-to-end precision fermentation operations within the pilot site (up to 100L bioreactors) as well main site production facility (up to 10KL bioreactors) and should be well-versed in Quality and Health, Safety and Environment (HSE) standards and Good Manufacturing Practices (GMPs).
• Conduct risk assessment for any task performed by Operations and maintenance teams, ensure risk register is maintained and operations team trained to meet statutory requirements.
• Develop Operational Standard Operating Procedure, Work Instruction and relevant forms/checklist and adequately train Operations team ensuring alignment with regulatory requirement and best practices.
• Responsible for all production personnel competency and readiness with sterile operations, including administrative management of manpower planning and developing work schedule, timesheets and Over Time management.
• Lead, develop and motivate the Production Technicians to ensure product safety, achieve production KPI, maintain building and equipment in optimal conditions and reduce planned and unplanned downtime.
• Facilitate and coach Tier#1 (shopfloor) meeting that is led by shift lead. Lead Tier#2 meeting (cross functional team inclusive of QA/QC, procurement) to resolve technical and/or operational issues, assign resources to address various performance problems.
• Initiate and implement improvement projects to current and future processes, including cost-reduction, manufacturability, functionality, and quality.
• Perform troubleshooting of quality and safety deviations/incidents, lead RCA, implement CAPA. Work closely with quality and process team to prevent and minimize subsequent events.
• Ensure operations area pest control, hygiene control through compliance to procedure.
• Ensure production and maintenance process is documented in system(s) used by the company.
• Manage the daily operations and troubleshoot for any abnormal operation of the Supervisory Control And Data Acquisition (SCADA) system.
• Lead in the emergency responses as Operations Lead.

MAINTENANCE RESPONSIBILITIES:

• Plan and implement Preventive Maintenance, corrective maintenance and calibration program for production, utilities(air compressor, chiller, boiler, PWP etc) and facilities(CCTV, Card access, fire alarm, sprinklers etc) system to meet the statutory, food safety requirements. Develop for the Preventive Maintenance.
• Develop Maintenance Standard Operating Procedure, Work Instruction and Job plan with relevant forms/checklist and adequately train Operations team ensuring alignment with regulatory requirement and best practices.
• Responsible for cleaning and maintenance of floor, wall, ceiling, platforms and machinery within operations area, with inhouse and or external service vendors.
• Manage contractors on work safety practices to ensure statutory requirements and procedures are followed and ensure that the vendors complete the Safety Induction Course (safety briefing) relevant safety documents are reviewed and meet requirements before start of work e.g. RA, SWP.
• Responsible for troubleshooting and rectification, the preventive/predictive maintenance of the Supervisory Control And Data Acquisition (SCADA) system.

MATERIALS MANAGEMENT RESPONSIBILITIES:

• Develop materials management strategies and prepare Standard Operating Procedures (SOPs), ensuring alignment with regulatory standards and best practices.
• Establish, refine and administer inventory programs to maintain the availability of necessary ingredients, packaging materials and spare parts while adhering to planned budgets.
• Responsible for process waste management, effluent discharge control to meet PUB limits. Off PUB limit effluent disposed through third party service provider. Solids waste disposal through third party service provider.