Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform.In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are looking for highly motivated, performance driven individuals to be a part of our expanding team.We do this by hiring amazing people guided by shared values who exceed customer expectations.Our continued success depends on it!Job Title: Associate Engineer - MalaysiaDepartment:Facilities EngineeringPosition Overview: The Associate Facility Engineer in Insulet Malaysia will lead a team of Technicians, outsource services team, and Contractors, ensure their daily activities support business objectives, comply with cGMP requirements, and manage their performance/development.The Associate Facility Engineer must keep the facility system timely, and the safety of our people, be focused on quality, be self-directed, be a motivated team player, and be a willing trainer—eager to gain and share new knowledge.The normal schedule for this role is Monday through Friday but the plant is a 24/7 operation and will require flexibility to maintain standards across all shifts.Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier.Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes.Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.Responsibilities: Ensure compliance with safety rules, quality policies, and employee guidelines.Formally evaluates the performance of team members and champions the professional development of the team.Manage attendance as part of team performance and coverage for absence/vacation requests.Assists in building the capability of the Facility Technicians with the facility equipment, controls, and systems and establish daily work standards to maintain equipment reliability.Use Lean principles and tools to drive a continuous improvement culture to improve safety, quality, efficiency, and cost.Good direct interaction with all facility customers or inter-department personnel and fulfill job requests accordingly in a timely manner.All job requests should be attended to within a 30-minute – 1-hour assessment and completed based on job criticality or type.Assist facility technician and closely follow up.Assists to develop training plans and material, write SOPs, and verify activities are performed as specified in documented work instructions.Lead root-cause investigations for facility equipment-related issues, deploy corrective actions, and develop preventive actions to eliminate recurrence with test equipment.Responsible for reporting safety, quality, and regulatory compliance concerns to leadership.Assists department on all authority, internal or relevant body audits, annual authority inspection, and statutory license renewal.e.g DOSH, DOE, BOMBA, SPKA, KPDNKK, and system application license renewal.Assists to complete periodic reviews and other compliance documentation aligned with the site QMS.Carry out, Assist, and plan preventative maintenance, and emergent repairs for facilities system (HVAC system and operations - air conditioning, heating and refrigeration units, building exhaust fans, ventilation units, Biosafety cabinet, Pass box (dynamic & static), LAF, Fume hood, all related to Air condition work, LEV and etc.).Performed Cleanroom Area qualification activity-based ISO class 8 and 9 and maintain a grade of design with follow ASHRAE standards and guidelines.Assists of technical work and Hands-on experience in troubleshooting and analyzing problems.Knowledge of pharmaceutical documentation work such as Deviation, CCR, Investigation report, preparing protocol, preparing PM Planner, Calibration Planner, Calibration master list, Prepare SOP, Prepare monitoring logbook, checklist for PPM, and other related document for the Facilities system.Good knowledge of monitoring and controlling systems such as BAS (building Automation system), BMS (Building management system), Control system, and EMS (Environmental monitoring system).Assist and involve in any drill exercise such as Fire drill, Emergency response.etc Analyse adverse trends and implemented corrective actions.e.g.energy, water consumption, and facility system Ensure to contribute to quality plans that have minimal interruptions and smooth return to service.Trained in-house technicians and contractors as required.Explore to learn about electrical works.Explore to learn about managing chiller, and cooling tower operations.All types of HVAC systems, and LEV systems such as preparing work schedules, assigning a daily job, tracking assigned jobs, and preparing daily incident reports of activity for supervisor and technician.Assists in managing calibration activity to all measuring and monitoring equipment of the HVAC system.Assist with monthly reports of the facility department.Explore to learn about CDA, Dryer, and Vacuum systems.Relate to daily operation, PPM.etc.Explore to learn about building maintenance (structure, drainage, water supply, Civils, sewerage, clean room environment) Explore to learn about Solar energy systems and energy efficiency programs.Manage contractors, vendors, and outsource service providers.Knowledge in drafting service and maintenance agreements.Assists in maintaining the spare parts inventories for critical components and consumable parts of the equipment.Knowledge of SAP system (system application and product).Always ready to carry out any new task assigned from time to time by a superior.Education and Experience:Minimum Requirements:Bachelor's Degree, or an equivalent combination of education and experience in electrical & electronics engineering, or equivalent background.Fresh graduate or 1-2 Years of experience with Facilities systems or relevant experience from manufacturing -PCBA, pharmaceutical, healthcare, and cleanroom industry.Fresh graduate or 1-2 Years of experience supervising or leading facilities division in a high-volume production environment.Chargeman certificate is an advantage.Process-oriented and uses data to make decisions.Ability to fulfill job responsibilities in a fast-paced/high-volume production environment.Committed to job roles without hesitation.Preferred Skills and Competencies: Strong PC and troubleshooting skills.Extensive knowledge of facility systems/equipment, electronic development, and PCBA production, functionality, and interaction.Proficient in computer skills, MS Word, Excel, PowerPoint, and Outlook.Requires electrical and software aptitude, technical ability, problem-solving skills, and ability to read and understand technical drawings and manuals.Have strong interpersonal and communication skills.Excellent attention to detail, organizational skills, and rigorous process discipline.Ability to adapt quickly to changes in daily work plans and unplanned issues on equipment, maintaining a focus on productivity without compromising safety or quality.Thirst for knowledge and intense curiosity.Sound decision-making using data analysis.Multi-language fluency preferred (English, Malay)Physical Requirements: Able to work all shifts and some weekends as required to support business objectives.Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.
