Manufacturing Engineer II - CCD Support

Continuous Improvement Analyst II

Lead, Card Operations Processing Centre

Quality Improvement Manager

Senior Project Management Engineer

Operations Manager

Quality Engineer

Associate, Quality Assurance (QMS)

Finance Controller

QC Chemist

Overview: <ul><li>Design and developed electrical control system,testing and qualification introduce advanced electrical control technology with the objective of ensuring new assembly equipment meets schedule and requirements from customers and ECO within the direction of department manager and staff manufacturing engineer.&nbsp;</li><li>Manage and trouble shooting of CCD and cost saving within direction of policies.</li></ul> Responsibilities: <ul><li>Trouble shooting, Modify or Create Machine PLC program to suit the need of the plant.</li><li>Responsible for repair and maintenance of the CCD System of the production line.</li><li>PLC system of the automation debugging and improve the sequencing.</li><li>Suggest improvement of automation PLC program to improve productivity and OEE.</li><li>Train technician to resolve the issues encountered between the production.</li><li>CCD light adjustments to improve the performance.</li><li>Responsible to resolve all issues encounter during production run.&nbsp;</li><li>Support on resolving CCD issues encounter during production run and documenting.&nbsp;&nbsp;</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li></ul> Requirements:&nbsp; <ul><li>Bachelor in Major in Electrical/Electronics</li><li>5+ years’ experience and practitioner in the automation assembly and Tooling Design &amp; Development</li><li>Computer Knowledge, MS Office etc, SAP knowledge added advantage</li><li>Integrity, Accountability, innovation, Communication.&nbsp;</li><li>Strong background in PLC programming: capable of programming, debugging, editing, and creating new PLC logic.&nbsp;</li><li>Familiar with CCD (Charge-Coupled Device) cameras, especially those used in automated measurement systems (e.g., Autoline).&nbsp;</li><li>Experience with vision system programming tools such as Visco, Keyence, and Datalogic.&nbsp;</li><li>Solid programming skills required; CCD-specific knowledge can be trained.&nbsp;</li><li class="ql-align-justify">Willingness to work on Saturdays when needed</li></ul>

Overview:﻿ <ul><li>Working with the Lean implementation team to integrate Lean tools into operations as well as drive performance improvement.&nbsp;</li><li>Act as the local subject matter expert for the Lean tools and be responsible for all Lean activities at the local site.&nbsp;</li><li>Develop and conduct the Lean star level plan by driving and monitoring the projects of operation advantage, providing necessary technical support and facilitating cross-functional team to meet the metrics as planned.&nbsp;</li></ul> Responsibilities: <ul><li>Overall manage plant annual lean plan, identifying key improvement priorities to enhance site performance in the eyes of all stakeholders.</li><li>To implement system in plant and achieve Star level plant through improvement activity.</li><li>Conduct site level workshops and VSM transformation projects with focus on achieving operational excellence.&nbsp;</li><li>Systematic to manager plant cost activity, identify/improve/control the efficiency, material, labor and be all aspect of the cost viewing. </li><li>Being responsible fofr driving conversion productivity.&nbsp;</li><li>Key member of global lean committee, share/provide/lead global projects and activities.</li><li>Take role as internal process/cost consultants, to assistant plant manager solve management issues</li><li>Provide leadership on lean thinking, lean processing and lean production, continue to promote the culture of continuous improvement.</li><li>Lead / lean know-how transfer projects, to implement, optimize and solve specific problems in operation&nbsp;</li></ul> Requirements: <ul><li>B.S. Degree in engineering or technical field.</li><li>Minimum 8 years working experiences, 3 years working experiences as Continuous Improvement at least.&nbsp;</li><li>Professional experience with focus on production, logistics or industrial engineering is an advantage.</li><li>Previous experience in leading both of continuous improvement activities and value stream transformation projects.</li><li>Good flexibility and can work under pressure</li><li>Demonstrate the ability to lead change, a great team-work player.</li><li>Excellent communication and coaching skills, strong leadership skills.</li><li>Ability to think strategically and execute tactically, being result-oriented.</li><li>Project management skills.</li><li>Fluent in both spoken and written English and local language is essential.</li><li class="ql-align-justify">Lean Six Sigma Black Belt Certification is an advantage</li></ul>

Responsibilities: <ul><li>Streamline processes to reduce operating cost and turnaround time without compromising quality and risk.&nbsp;</li><li>Conduct internal reviews / tests to ensure compliance.</li><li>Assist with data analysis, report findings, recommend corrective actions and preventive actions for review.&nbsp;&nbsp;</li><li>Proactively manage and resolve customers’ and business units’ feedback and queries promptly.</li><li>Drive operations related projects &amp; process improvements.</li><li>Lead and coach staff to a high standard of performance, productivity and service quality</li><li>Ensure that the Bank’s policies, guidelines, operations control and compliance requirements are strictly adhered to.</li><li>Ensure that operation procedures are kept up to-date.</li><li>Identify opportunities to improve productivity, efficiency and service quality in the team and within the division while assuming the role as a mentor to coach staff to ensure high standard of performance, productivity and service quality.</li></ul> Requirements: <ul><li>5 to 10 years of retail banking operations, especially in Credit/Debit Cards Operations&nbsp;</li><li>5 to 10 years of team management experience with a minimum size of 10.</li><li>Able to multi-task and cope with change and diversity in a fast-paced environment</li><li>Experience in change management projects, including successful RPA and automation implementations.</li><li>Strong organizational and management skills with strong leadership qualities</li><li>Strong analytical and problem-solving skills</li><li>Strong interpersonal and communication skills with excellent verbal/written communication and interpersonal skills.</li><li>Ability to think objectively and think outside the box when analyzing issues</li><li>Ability to work under pressure.</li></ul>

Role Information: <ul><li>The Quality Improvement Manager is responsible to drive and support improvement activities and convergent Problem-Solving competencies within AUT ASEAN, leveraging scalable methodologies and digital tools while unleashing people’s talent.</li><li>Working in collaboration with production plant at Gateway Thailand towards waste reduction and improving Incidents on our customer base.&nbsp;</li><li>She/he is the Leader in ASEAN Problem Solving Committee and leads cross functional teams to solve complex and difficult manufacturing and quality problems.</li><li>She/he contributes to the project selection that will have the highest impact on plant metrics.</li><li>She/he coaches plant problem solvers and ensures their development</li></ul> Responsibilities: <ul><li>Leader in ASEAN Problem Solving (PS) Committee.</li><li>Organize regular meeting review status &amp; planning.</li><li>Promote PS culture throughout the Plant and ASEAN at all levels.</li><li>Promote the selection of the projects that will have the highest impact on plant metrics (eg. CoPQ) and manage all PS projects including PS initiatives from Line QRM escalation to VSM/Plant Level.</li><li>Support production improvement process through PS projects.</li><li>Lead cross-functional team to apply diligently a structured problem-solving methodology that best fits the situation (Shainin, SPS, Six Sigma or other equivalent methods as described by the Shifting Gears)</li><li>Follow up all PS projects with project owner and provide coaching to ensure PS methodologies are correctly applied.</li><li>Regular project coaching with PS Master from Global, and follow-up to project closure and realize saving.</li><li>Proactively anticipate roadblocks to find solutions and escalate when needed.</li><li>Report out project progress, people development and savings to PS Committee and Management.</li><li>Tabulate and manage Plant/ASEAN people PS skill matrix and identify training needs, plan &amp; execution.</li><li>Coach, Develop and Expand local Problem Solver Practitioners.</li><li>Represent ASEAN in PS matter and report status to regional and global level.</li><li>Alignment with AP and Global PS leaders for new PS initiatives and execution.</li><li>Any other assignments as delegated by reporting Manager.</li></ul> Requirements: <ul><li>Engineering degree (Mechanical or Electrical Engineering).</li><li>Strong understanding of 6 Sigma tools and Minitab usage.</li><li>Strong understanding of engineering fundamentals and product design</li><li>Experience in taking project using structured problem-solving methodology (Shainin Red-X, 6 Sigma, etc).</li><li>Experience in coaching and training.</li></ul> Specific Requirements(Mandatory): <ul><li>Certified Red X Master or Master Candidate (ability to coach) or Kepner-Tregoe.</li><li>Strong understanding of 6 Sigma tools and Minitab usage.</li><li>Able to develop Dashboard (PowerBI) and to apply Data Science (Python, R).</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: Policies and Procedures (10%): <ul><li>Develop and implement the manufacturing related policies and procedures in order to align with government regulation and corporate policy, organize the formulation of the responsibilities of management personnel at all levels, and optimize the internal structure and staffing.</li><li>Develop and implement assembly function budget and plan allocate function target to subordinates and monitor the achievement of the budget and overall performance in order to achieve targeted of Plant performance.&nbsp;</li></ul> People Management (15%): <ul><li>Allocate and balance work across direct reports&nbsp;&nbsp;</li><li>Review and provide timely performance feedback to direct reports&nbsp;&nbsp;</li><li>Mentor, develop and motivate them&nbsp;</li><li>Help resolve people/functional issues in the team&nbsp;</li><li>Submit manpower application and interview the candidates in order to achieve targeted department performance and retain key talent.&nbsp;</li></ul> Production (25%): <ul><li>Supervise and monitor the production activities and process&nbsp;</li><li>Help to solve critical production issues&nbsp;</li><li>Cooperate with other functions within molding department and other departments in getting necessary support in order to ensure the normal day-to-day production.&nbsp;</li></ul> Assembly (25%):&nbsp; <ul><li>Review the maintenance plan&nbsp;</li><li>Monitor the maintenance plan execution&nbsp;</li><li>Approve the Purchase Request for spare parts&nbsp;</li><li>Provide overall mold/Die/Tool maintenance instruction and monitor the execution in order to ensure the normal operation of die and improve daily operating efficiency.&nbsp;</li></ul> Equipment maintenance (5%): <ul><li>Review the maintenance plan&nbsp;</li><li>Monitor the maintenance plan execution&nbsp;</li><li>Approve the Purchase Request for equipment and parts&nbsp;</li><li>Provide overall equipment maintenance instruction and monitor the execution in order to ensure equipment operate reliably and improve daily operating efficiency.&nbsp;</li></ul> Engineering (10%):&nbsp; <ul><li>Allocate new projects to engineers&nbsp;</li><li>Monitor the new project process and control the cost and schedule&nbsp;</li><li>Provide cross functions/departments coordination&nbsp;</li><li>Help to solve critical technical issues in order to ensure the successful completion of the project.&nbsp;</li></ul> EHS (5%):&nbsp; <ul><li>Formulate and perfect the department EHS management system and operational procedures, and ensure the effective implementation.&nbsp;</li><li>Fully understand and implement EHS responsibilities to ensure EHS work in department meets relevant requirements&nbsp;</li><li>Set departmental and individual EHS performance targets according to laws and regulations and requirements of the company, and check and evaluate the completion of the targets regularly&nbsp;</li><li>Check the safety situation of production site regularly to eliminate all kinds of unsafe factors and prevent accidents.&nbsp;</li></ul> Project Management and Activity (10%):&nbsp; <ul><li>To reduce the costs and improve efficiency of the department, organize and plan key improvement projects, and monitor the implementation of these projects (Tebit Saving, Kaizen)&nbsp;</li><li>In order to improve and cooperate with the plant in implementing the excellent operation objectives, actively participate in training and use tools for improvement, such as VS Transformation, CCF, etc.</li></ul> Requirements: <ul><li>Bachelor and above Degree&nbsp;</li><li>Good English skills (written and oral)&nbsp;</li><li>Min. 10 years shopfloor management experiences in elec. Industry, above two years on managerial positions&nbsp;</li><li>Solid Lean/6 Sigma knowledge and project experiences&nbsp;</li><li>Familiar with quality system and tools&nbsp;</li><li>Rich experiences in operator training and development&nbsp;</li><li>Planning knowledge and experiences&nbsp;</li><li>Proficient PC skills.</li></ul>

Responsibilities: Provide review and drive to approval of the validation protocols and reports for facility, equipment, laboratory instrument, and utility systems. <ul><li>Review and approval of technology/method transfer protocols and reports.</li><li>Review and evaluation of change controls</li><li>Review and approval of deviations and assurance that they define root causes and determine appropriate CAPA.</li><li>Participate in cross-functional teams to support execution of commissioning, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and validation protocols.</li><li>Provide quality presence during qualification execution, ensuring data integrity, deviation management, and proper documentation of results.</li><li>Support the timely review and approval of executed qualification documentation and ensure readiness for inspection or submission.</li><li>Drive timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing validation, change control, deviation, and other SOPs relevant to the responsibilities</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Ensure proper execution of Good Documentation Practices (GDP) in all QA-reviewed documents, including validation records, logbooks, and manufacturing records.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits, with emphasis on operational and qualification-related topics.</li><li>Monitor key quality metrics and drive performance improvements in areas such as deviation reduction, batch record right-first time, and qualification readiness.</li><li>Contribute to the continued inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in engineering or technical discipline (e.g., engineering, Biology, Chemistry, Pharmacy).</li><li>5+ years of experience in pharmaceutical manufacturing QA, including direct involvement in qualification/validation activities.</li><li>Prior experience reviewing or approving qualification protocols and validation reports in GMP environments.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills/Competencies <ul><li>Strong knowledge of validation principles and qualification documentation expectations.</li><li>Effective team leader with experience supervising QA staff and coordinating cross-functional support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, engineering, and validation stakeholders.</li><li>Sound judgment and decision-making under pressure in a dynamic manufacturing environment.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

Role Description: <ul><li>The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.</li><li>This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.</li></ul> Responsibilities: <ul><li>Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.</li><li>Support the preparation and tracking of quality metrics and trending reports.</li><li>Help coordinate internal audits and document audit responses.</li><li>Participate in documenting product quality complaints and adverse event records.</li><li>Aid in digitizing logbooks and checklists using electronic systems.</li><li>Collaborate with cross-functional teams to ensure timely and accurate documentation updates.</li><li>Provide administrative support for change control processes and quality-related meetings.</li><li>Assist in preparing documentation for regulatory inspections and external audits.</li><li>Maintain document control systems and ensure timely review and archival of QA records.</li><li>Support training documentation and tracking for QA-related procedures.</li><li>Help with data entry and analysis for quality reports using basic statistical tools.</li><li>Monitor document lifecycle and ensure version control compliance.</li><li>Participate in continuous improvement initiatives related to documentation and QMS processes.</li></ul> Requirements: Education &amp; Experience <ul><li>Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.</li><li>Preferred Education: Master’s degree is a plus.</li><li>Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).</li><li>Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.</li></ul> Physical Requirements <ul><li>On-site role at Chestnut Ridge, NY.</li><li>Standard work hours: 8 AM to 5 PM.</li><li>No travel required.</li><li>No lifting or driving responsibilities.</li></ul>

Responsibilities: <ul><li>Management of finance team to ensure delivery of timely, accurate monthly accounts, preparation of the financial pack and KPIs.</li><li>The key focus will be to drive financial and business improvements in the Filter Products manufacturing site and to act as a business partner to the local GM and management team.</li><li>Support is also required for the local Distribution business.</li><li>Review site month end financials, prepare variance analysis with supporting commentary consolidate for the Hungary region.</li><li>Drive site Gross margin and Non-productive spend initiatives.</li><li>Prepare and review customer and product analysis (pricing, revenue and margin).</li><li>Drive working capital improvements including cash collection and inventory management.</li><li>Ensure that standard costs are maintained and implemented across the product range in the Filter Products manufacturing site.</li><li>Review site control files and trial balances to ensure no financial risk to the business and instil robust financial controls.</li><li>Ensure that all sites comply with the Filtrona Accounting Manual (EAM).</li><li>To support the businesses in the preparation of the annual Plan and quarterly forecasts for the region and associated presentations and packs.</li><li>Review of all capex appraisals pre sign off and follow up on actual spend v plan.</li><li>Attend and present the financials at the monthly operational reviews.</li><li>Legal and banking signatory for the Filter Products business and sign off monthly payroll run.</li><li>Review monthly FX hedging forecasts and submissions to Group Treasury</li><li>Deal with Group, SBU and Regional FD requests</li><li>Lead the preparation for the Hungarian internal and external audits.</li><li>Develop staff and identify training needs within the team. Document standard procedures.</li><li>Keeping the HSE-, fire safety- and hygiene rules, wearing the relevant personal protective equipment.</li><li>During the daily work meeting the expectations of the Integrated Management System regulations.</li></ul> Requirements: <ul><li>Educated to degree level (potentially in Finance, Accounting, or Economics); professional accounting qualification.</li><li>10 years PQ experience within a manufacturing environment is essential.</li><li>High level of numeracy and IT literate (Excel/PowerPoint).</li><li>Excellent English written and oral communication skills.</li><li>Audit background</li><li>ERP system knowledge</li><li>Project management knowledge and experience</li></ul>

Role Description: <ul><li>The QC Chemist will be a critical member of the laboratory team responsible for performing analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility.</li><li>This role will support the development, validation, and execution of analytical methods, ensure timely release of raw materials, in-process samples, and finished products, and maintain strict adherence to cGMP, FDA, and global regulatory standards.</li><li>The QC Chemist will play a key role in establishing laboratory operations during the startup phase and sustaining high standards of laboratory excellence throughout routine commercial production.</li></ul> Responsibilities: <ul><li>Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated methods (e.g., HPLC, GC, UV-Vis, FTIR, TOC, etc.).</li><li>Develop and validate new analytical methods as required to support product development, regulatory submissions, and process optimization.</li><li>Ensure compliance with cGMP, FDA, USP, and other regulatory standards in all laboratory activities, documentation, and data integrity.</li><li>Prepare and review laboratory documentation including test protocols, reports, COAs, deviations, OOS investigations, and change control documentation.</li><li>Maintain laboratory instruments, perform routine calibrations, troubleshooting, and coordinate with vendors for preventive maintenance and repairs.</li><li>Support laboratory readiness for regulatory inspections, audits, and customer visits by maintaining audit-ready documentation and laboratory practices.</li><li>Assist in the preparation and execution of laboratory investigations, CAPA implementation, and root cause analysis for any analytical deviations.</li><li>Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Validation, and Regulatory Affairs to ensure seamless batch release and product compliance.</li><li>Participate in training programs to ensure technical competency and adherence to evolving regulatory requirements.</li><li>Contribute to continuous improvement initiatives focused on laboratory efficiency, data integrity, and compliance robustness.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s or master’s degree in chemistry, Pharmaceutical Sciences, or related field.</li><li>3+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing.</li><li>Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, etc.) and GMP-compliant laboratory operations.</li><li>Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations.</li><li>Experience supporting laboratory investigations and regulatory inspections.</li></ul> Skills/Competencies: <ul><li>Strong analytical and problem-solving skills.</li><li>High attention to detail and accuracy in laboratory work.</li><li>Good understanding of data integrity and documentation practices.</li><li>Ability to work both independently and as part of a team in a dynamic startup environment.</li><li>Excellent organizational, time management, and communication skills.</li><li>Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.</li></ul>

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73 control gears Jobs found

Manufacturing Engineer II - CCD Support

Continuous Improvement Analyst II

Lead, Card Operations Processing Centre

Quality Improvement Manager

Senior Project Management Engineer

Operations Manager

Quality Engineer

Associate, Quality Assurance (QMS)

Finance Controller

QC Chemist

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73 control gears Jobs found

Manufacturing Engineer II - CCD Support

Continuous Improvement Analyst II

Lead, Card Operations Processing Centre

Quality Improvement Manager

Senior Project Management Engineer

Operations Manager

Quality Engineer

Associate, Quality Assurance (QMS)

Finance Controller

QC Chemist

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