Senior Manager, Project Management and Engineering

"Any sufficiently advanced technology is indistinguishable from magic. -Arthur C. Clark"_ At Genetic Design and Manufacturing Corporation (GDMC), we believe in bringing the magic of novel genetic medicines to patients by innovating in manufacturing technologies that are critical to the delivery of that vision. This exponential improvement in manufacturing will allow for de-bottleneck the clinical testing and approval of new genetic medicines such as gene therapies to make blind people see, or the next mRNA vaccines. GDMC is a venture-backed, fast-paced and Singapore-HQ'ed start-up and we want you to join us on this mission, to accelerate our growth by sourcing, screening and supplying key talent for all of GDMC **Responsibilities** 1. Capital and Continuous Improvement Project Management: - Design, Build and Qualification projects deploying lean approach planning, scheduling, and control to ensure project is implemented safely and efficiently in GDMC. - Coordinate with Finance on capital budget planning, monthly tracking of the capital budget/spend to ensure accurate updating, spending control and reporting. - Must have the ability to deploy regulatory requirements and biopharmaceuticals standards in preparing User Requirement Specifications, Project Quality Plan and Functional Requirement specifications. Project execution to include voice of customers to ensure completeness of scope of work, user's requirements, functionality in basis of design and detail design activities. - At minimum, must be familiar with all relevant ISPE guidelines, ICH guidelines, FDA cFr guidelines, ISO 14644, 8573 etc, ASHRAE, ASTM E2500, OSHA or EPA and relevant engineering standards. - Must be familiar with all Singapore code of practices and government submission workflow. - Close collaboration with users and validation team in establishing GMP workflow, GMP review, risk assessment (safety, quality and construction), operability and maintainability assessment. 2. Engineering Planning, Maintenance and Calibration: - Set Up Engineering computerized maintenance and calibration system. The Master data set-up must be accurate and update to meet equipment and facility life cycle management. - Prepare all SOP related to efficient maintenance and calibration system. - Set-up reliability engineering management system. - Coordinates with Warehouse/Supply Chain Management to optimize engineering spare parts to avoid over-stocking and avoidance of obsolescence but avoidance any possibility of stock out. - Implement efficient utilities system operation coupled with efficient energy management system implementation. - Training or engineers to increase skills and knowledge management in line with company talent management and succession planning. 3. Operational Efficiency (OE) Management and Problem Solving: - Deployment of OE tools: SIPOC, Swimlane, DMAIC, Pareto Analysis, Ishikawa Tools in establishing Continuous Improvement in both Project and Engineering System in GDMC. - Track all Continuous Improvement Project to ensure Green/Yellow Belts Assignees are in Control of their projects. - Support all other departments in ensuring that cross functional coordination activities that meets company key objectives. 4. cGMP Compliance and Standard: - Understand and comply with related cGMP documentation, principles, quality standards and SHE (Safety Health and Environmental) requirements in performing assigned work. - Keep track of department training records and track status on regular basis. - Keep track of department engineering change control records including status and closure of change control documentation. - Implementation of HVAC performance system, utilities efficiencies, maintenance, and calibration reliability matrixes. **Qualifications**: - Master's degree in mechanical or Chemical Engineering with at least 10 years' experiences as Project or Engineering Manager in biotech, pharmaceutical or chemical process industry. Preferably PMP certified. - Excellent computer skills in Microsoft Project, Gantt Chart scheduling, Mini-Tab, SAP, Track wise or equivalent system, CMMS (Computerized Maintenance Management System) software, spreadsheets, and word processing software. - Excellent analytical problem-solving skills and persistence to resolve outstanding issues with knowledge of FMEA, KT problem solving skills or OE or OEE experiences. - Excellent inter-personal and communication skills, both written and verbal. - Must possess the ability to work independently and deliver projects/tasks on time and within budget. - Direct and coordinate the Manufacturing and Equipment Operations activities including the supervision and training of personnel. - Must be team oriented and be able to lead and direct groups of service contractors on site. - Self-motivated, independent and initiative.