Facility Mechanic

Sr. MFG & Process DVL Engineer

MFG & Process Development Engineer II – Molding

Responsibilities: <ul><li>Perform preventive and corrective maintenance, troubleshooting, and repairs on facility infrastructure and critical utilities, including HVAC systems for cleanroom environment, compressed air and vacuum systems, clean utilities (WFI, purified water, clean steam), boilers, chillers, temperature control units, and effluent water treatment equipment.</li><li>Support equipment setup, calibration, qualification, and creation of maintenance plans of facility utilities and equipment.</li><li>Conduct round and inspection to monitor system performance and proactively address issues.</li><li>Ensure proper gowning, cleanliness, and contamination control practices when working in classified cleanroom environments.</li><li>Document all maintenance activities accurately in maintenance logs, work orders, and computerized maintenance management systems (CMMS).</li><li>Collaborate with Engineering, Manufacturing, and Quality to support equipment investigations, deviations, and continuous improvement initiatives.</li><li>Follow all safety procedures, including lockout/tagout, confined space, and PPE use; actively contribute to a culture of workplace safety and compliance.</li><li>Maintain spare parts inventory, tools, and maintenance supplies in an organized and audit-ready condition.</li><li>Participate in training and cross-functional activities to support plant startup and readiness for regulatory inspections.</li><li>Provide technical support of production activities during absence of production support team members or when bandwidth is insufficient.</li></ul> Requirements:﻿ <ul><li>High school diploma or technical certificate required, Associate’s degree in a mechanical or technical field preferred.</li><li>3+ years of experience as a mechanic or technician maintaining utilities or facilities infrastructure in a pharmaceutical, biotech, or regulated manufacturing environment.</li><li>Experience with pharmaceutical manufacturing equipment and cleanroom protocols is highly desirable.</li><li>Strong troubleshooting skills for mechanical, electrical, and control system issues.</li><li>Familiarity with building management systems (BMS) and alarm monitoring systems.</li><li>Solid electrical and controls experience with automated systems, inspection machines, robotics, and camera systems highly preferred.</li><li>Understanding of cGMP, contamination control, and safety regulations (OSHA, FDA, EU Annex 1).</li><li>Ability to read and interpret mechanical drawings, equipment manuals, and SOPs.</li><li>Familiarity with CMMS platforms and basic computer skills (e.g., Microsoft Office).</li><li>Self-motivated with strong attention to detail, problem-solving skills, and the ability to work independently or in a team.</li><li>Willingness to work flexible hours, including weekends or off-shifts during production or commissioning activities.</li></ul> Work Environment: <ul><li>Hands-on role in a regulated, sterile pharmaceutical manufacturing facility with strict safety and aseptic requirements.</li><li>Requires frequent gowning, standing, and work in confined or classified areas.</li><li>Fast-paced startup environment, requiring adaptability, initiative, and a collaborative mindset.</li><li>Occasional lifting of heavy tools or parts; use of ladders, lifts, and hand tools required.</li><li>Physical requirements include lifting climbing ladders, electrical troubleshooting, and working with hand and power tools</li></ul>

Responsibilities: <ul><li>Participates in the Design and Development of tools and molding processes to support the development of new products.</li><li>Provides support in product development, manufacturing optimization designs, tooling sampling, product samples, and prototypes.</li><li>Determines the most suitable manufacturing concepts for tooling related to forecasted production quantities, quality requirements, and manufacturing location</li><li>Responsible for collaborating with global experts (CoE molding) to continuously update and improve operational standards regarding plastic injection molding</li><li>Responsible for providing budgets for new tools and molding processes.</li><li>Responsible for ensuring, together with the multidisciplinary team, that molds and processes are designed to produce high-quality products efficiently and effectively with the lowest possible cost.</li><li>Responsible for coordinating and tracking engineering changes to injection molds.</li><li>Responsible for supporting the management of resources for the mold shop area.</li><li>Responsible for participating in the Plants Continuous Improvement Programs.</li><li>Provides support in analyzing tooling and equipment capacities for new part numbers and changes in quoted volumes.</li><li>Responsible for participating in the development of new products, engineering changes for molds, ensuring adherence to engineering and internal standards.</li></ul> Requirements: Preferred Years of Experience / Minimum Qualifications: <ul><li>Bachelor’s degree in Mechanical Engineering or similar.</li><li>5+ years of experience in a similar role.</li><li>Team management experience.</li></ul> Required Skills and Competencies: <ul><li>Proficiency in design software (CAD): Creo (Pro-E), SolidWorks, Space Claim, AutoCAD, CATIA (preferably).</li><li>Proficiency in machining software (CAM): Creo ProNC, Mastercam, SolidCam (preferably).</li><li>Proficiency in plastic filling simulation software (CAE): Moldflow, Autodesk Moldflow, ANSYS.</li><li>Basic knowledge of plastic injection molding processes.</li><li>Strong knowledge in tool manufacturing, tool steel application/selection, heat treatment, and plating/coating.</li><li>Strong understanding of polymer technology, particularly engineering-grade resins.</li><li>Knowledge of Scientific Injection Molding and/or Mastermolding Certification (desirable).</li><li>Knowledge of Six Sigma and LEAN principles.</li><li>Knowledge of geometric tolerances.</li><li>Strong project management skills, with the ability to handle multiple projects simultaneously.</li><li>Understanding of practices, terminology, and tolerances associated with manufacturing, machining, grinding, wire EDM, casting, etc.</li><li>Availability to travel (25% of the time).</li><li>Proficiency in Microsoft Office Suite.</li><li>Knowledge of SAP.</li><li>Ability to exercise effective leadership.</li><li>Ability to read specialized reports (scientific and technical papers, legal reports).</li><li>Intermediate - Advanced English proficiency (85%).</li><li>Applicable knowledge for the position in IATF 16949 and ISO 14001.</li><li>Knowledge of the company’s safety regulations and environmental management system.</li></ul>

Responsibilities: <ul><li>Overall molding process development, coordinating with interaction processes (Stamping, Plating, Assembly) to ensure the best process and cost for F/Gs</li><li>Concept design &amp; proofing for Molding process and tooling, Process development DOE.</li><li>Technical leader and trouble shooter from LVM to HVM in process development, tooling design &amp; qualification, issue finding and problem solving</li><li>Platforming manufacturing process development.</li><li>Challenge product design for manufacturability and cost feasibility.</li><li>Launch product at rate through FACA/QCPA tools (yield, CPK, OEE…)</li><li>Launch product on time with cross function team.</li><li>Process documentation (DFM，FMEAs, WI, FACA/QCPC…)</li></ul> Requirements:﻿ <ul><li>Bachelor or above degree in mechanical engineering or related background.</li><li>5+ years Mold design, Process and Troubleshooting knowledge / experience.</li><li>Strong knowledge of tool fabrication, tool-steel application/selection, heat treating, and plating/coating.&nbsp;</li><li>Strong knowledge of injection molding processes (Injection, Insert-molding, two-shot, etc.).</li><li>Strong understanding of plastic, injection machine, auxiliary equipment (strip feed, camera, etc).</li><li>Good at Mold flow simulation and analysis.</li><li>Familiar with BTI 5-Step process, and Knowledge of SIM (Scientific Injection Molding).</li><li>Understand tolerance calculations and Geometric Dimensioning and Tolerancing.</li><li>Data oriented issue finding and problem-solving skills.</li><li>Rich shopfloor hand on experience.</li><li>Sensitive on product cost, know how to drive cost through manufacturing process development &amp; design optimization.</li><li>Fluent in using of basic process development related tools like DFM, PFMEA，DOE，FAA, CTAR，CAD，Pro E</li><li>Knowledge of quality control and quality issue analysis and improvement</li><li>Good teamwork and communication skills。</li><li>Fluent in written and Spoken English.</li><li>Oversea working experience is a plus</li></ul>

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Facility Mechanic

Sr. MFG & Process DVL Engineer

MFG & Process Development Engineer II – Molding

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Facility Mechanic

Sr. MFG & Process DVL Engineer

MFG & Process Development Engineer II – Molding

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