Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

Assistant Brand and Innovation Project Manager (Contractual) 

Senior Project Management Engineer

QE Specialist

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills / Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to Production Technician I personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Demonstrated problem-solving and mechanical troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Uses a set of tasks and techniques to work as a liaison among and elicit the needs of stakeholders to define and validate solutions that meet business needs, goals, or objectives.</li><li>Analyzes and synthesize information elicited from stakeholders, defines, and manages the plan to deliver requirements and documents, and manages requirements throughout the project life cycle.</li><li>Develop ETL (Extract, transform, load) process to help extract and manipulate data from multiple sources.</li><li>Reformulating or automating the existing data workflows to maximize their functioning and greater scalability.</li><li>Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, and produce actionable business insights out of it.</li><li>Need to conduct complex data analysis and improve data quality and efficiency.</li><li>Develop models to create reporting infrastructure/dashboards for business process management and data mining.</li><li>Design Summary, Detail, and Dashboard reports and management summaries which present data findings in a professional, concise, and readable format appropriate for content and audience.</li><li>Solve ad-hoc requirements of Management related to data for critical decision making</li><li>Troubleshoot data inaccuracies, identify root causes, and take corrective action</li><li>Effectively communicate and translate quantity findings (Storytelling with data) inclusive of key insights and actionable recommendations to optimize performance</li><li>Optimize reports to ensure a responsive solution when visualizing vast amounts of data.</li></ul> Requirements: <ul><li>5+ years of data engineering experience in ETL design, development, optimization &amp; testing using, Alteryx, Data Bricks, Cloud AWS Services, Python, SQL scripts,</li><li>5+ years of hands-on experience in business intelligence and in configuring, designing, and building visualizations and dashboards using Tableau and other BI tools (Tableau Prep, Tableau Dashboard, Tableau Server, Business Objects, Power BI, etc.)</li><li>Excellent problem-solving, communication, and organizational skills.&nbsp;</li><li>Experience in performance tuning and optimization of ETL processes to enhance efficiency and minimize data processing time</li><li>Detail-oriented with excellent time management and organizational skills to meet a critical deadline</li><li>Self-motivated, ability to prioritize work and multi-task across many assignments in a fast-paced work environment</li><li>Collaborated with cross-functional teams to gather requirements, design data models, and implement scalable data architectures to support business analytics and reporting needs</li><li>Proven ability to work independently and with a team.</li><li>Ability to interpret technical or dashboard structure</li><li>Experience in business domains – supply chain, pricing, sales &amp; marketing, sales, finances</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>

Role Description:&nbsp;<ul><li>Senior Manager – Customer Service is responsible for continuing to drive transformational customer centric strategies geared around delivering extraordinary customer experiences and driving sales growth for the team, while continuing the transformation of our Customer Care organization to a revenue generation organization through consultative selling. </li><li>The Manager would be also responsible for delivering a level of service &amp; driving unsurpassed growth which builds strong customer relationships to make client the supplier of choice. </li><li>Support Solution Center strategic initiatives and drive operational excellence. Support and mentor fellow team Leaders to meet/exceed organizational goals.</li></ul>&nbsp;Responsibilities:&nbsp;<ul><li>Responsible &amp; Accountable to drive revenue and revenue growth.</li><li>Ensure that customer’s challenges are solved by providing excellent customer experience that exceeds customer expectations.</li><li>Implement processes and methods to eliminate barriers and inhibitors to success on a local level.</li><li>Understands market influencers and conditions.&nbsp;</li><li>Drive/influence our current/future product positioning to gain or re-gain market share.&nbsp;</li><li>Understands key components of a Competitive Landscape: customers’ needs and how you can address those needs; how you compare against your competitors in meeting those needs.&nbsp;</li><li>Drives brand awareness and positioning with our customers and distribution partners (Solutions and capabilities).</li><li>Think strategically and lead multiple teams.</li><li>Mentor and develop team Leaders and nurture an environment where they can excel in their current role.</li><li>Own and be accountable for achieving specific departmental objectives and in meeting both sales and Customer Experience goals of Solution Center India.</li><li>Lead and drive all Global Solution Center strategic initiatives in India.</li><li>Equip your team to develop, enhance and grow customer relationships through lead generation, building an opportunity pipeline, nurturing customers through their buying journey and driving customer loyalty.</li><li>Observe and coach your team in their work activities, providing immediate feedback through coaching discipline and following up to ensure appropriate actions are taken by the team</li><li>Recruit new talent and develop a strong talent bench that will embrace the vision and transform the organization.</li><li>Champion transformation initiatives and positively drive the change initiatives within the team.&nbsp;</li><li>Drive operational excellence and continuous improvement mind-set within your team.</li><li>Grow and nurture your team by providing inclusion and engagement opportunities, as well as developing them for their future careers.&nbsp;</li><li>Liaising effectively with various internal business partners like engineering, planning, and sales to resolve Customer inquiries and requests.</li></ul> Requirements:&nbsp; QUALIFICATIONS &amp; EXPERIENCE&nbsp;<ul><li>Bachelor’s degree in Engineering/Management/Science required, MBA preferred.</li><li>Overall 20+ years of professional experience in a multi-national Sales &amp; Business development role leading Sales operations and/or Customer support, with at least last 10 years of experience in Managerial position leading large teams with good proven track records driving sales, customer satisfaction and developing high performing teams.</li><li>Previous experience working in Corporate Sales and should have managed Channel sales, Distribution, customer support &amp; contact center.</li><li>Proven success record of change management efforts in pre &amp; Post Sales Process, customer Support &amp; Sales functions.</li><li>Proven experience of leading large and multi layered teams</li><li>Strong Skills to Drive Opportunity/leads through system like SFDC.</li><li>Excellent knowledge of management methods and techniques.</li><li>Demonstrated experience in working effectively and directly with all levels of the organization.</li><li>Industry specific experience is a plus.</li><li>Excellent communication skills.</li></ul>&nbsp;COMPETENCIES/SKILLS:&nbsp;<ul><li>Customer ‘centric’ and sales mind-set.</li><li>Business Acumen.</li><li>Consultative Selling experience &amp; skills.</li><li>Ability to lead team spread in different countries within your region.</li><li>Servant Leadership.</li><li>Result oriented.</li><li>Ability to maintain progress on multiple tasks, set priorities, and manage time effectively</li><li>Ability to adapt, be agile and drive change.</li><li>Strong communication (written and verbal), persuasion and interpersonal skills</li><li>Ability to establish strong business relationships with other Business units and cross functional departments.</li><li>Ability to influence without authority</li><li>Collaborative, ability to build strong relationships with cross-functional partners within a global and diverse organization.</li><li>Demonstrate proactive positive attitude and instill the same within the team.</li></ul>&nbsp;KEY PERFORMANCE MEASUREMENTS:&nbsp;<ul><li>Strategy, Execution and Talent (SET).</li><li>Employee Engagement.</li><li>Revenue &amp; New Customer Acquisition.</li><li>Customer Effort Score.</li><li>Efficiency/Productivity Improvement.</li></ul>&nbsp;MOTIVATIONAL/CULTURAL FIT&nbsp;<ul><li>Be a coach.</li><li>Building Effective teams.</li><li>Managing and Measuring Work.</li><li>Self-Motivated.</li><li>SET: Strategy, Execution, Talent (for managers).</li><li>Values: Integrity, Accountability, Inclusion, teamwork, Innovation.</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: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

This is 1 year Contractual role. Responsibilities: Brand management (60%): <ul><li>Assist in planning and executing marketing communication activities (online &amp; offline).</li><li>Support always-on social content, ensuring consistency with brand tone and direction.</li><li>Coordinate day-to-day campaign operations and timelines— from briefing, production, posting, to performance tracking.</li><li>Work closely with internal teams and external partners (e.g., creative, production, KOLs, and agencies) to deliver high-quality output on time.</li><li>Participate in on-site productions or shoots, providing brand and communication support.</li><li>Develop and manage internal brand POSM and marketing materials.</li><li>Handle agency/vendor coordination — contracts, deliverables, and follow-ups.</li><li>Manage procurement and finance tasks (PO, invoice, and payment documents).</li><li>Track and summarize campaign &amp; social performance reports.</li><li>Conduct market/competitor research and trend monitoring.</li><li>Coordinate with cross-functional teams (media, sales, PR, trade) for alignment.</li><li>Organize and maintain brand asset files, content calendars, and approvals.</li><li>Support brand events and activations, including logistics and materials.</li><li>Provide general administrative and coordination support for daily brand operations.</li></ul> Innovation project management (40%): <ul><li>Facilitate and drive forward end-to-end SAP code creation for new product development projects and Lift and Launch projects to align with the master timeline and ensure proactive communication across all departments such as Commercial, Supply Chain, Logistic, R&amp;D, Procurement, and Finance.</li><li>Monitor project progress and handle arising issues to ensure all projects are completed on time.</li><li>Coordinate with cross-functional departments to ensure smooth execution of projects without delays.</li><li>Immediately inform the supervisor if encounter problems that may affect the NPD project timeline and provide updated progress solutions.</li><li>Perform other related tasks as assigned by the superior on a case-by-case basis.</li><li>Work effectively and collaboratively with stakeholders across borders and within a complex matrix organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in marketing, communications, business administration, engineering &amp; science or related field.</li><li>Minimum 2-4 years’ experience in Marketing, Brand management, Social media management, project management &amp; coordination in Food or FMCG manufacturing industry would be advantage.</li><li>Passionate about brands, social media, creative communication, and innovation.</li><li>Detail-oriented, proactive, organized, and good at multitasking during urgency.</li><li>Strong coordination and communication skills with a positive attitude.</li><li>Basic understanding of procurement and finance workflow (PO/Invoice).</li><li>Familiar with digital and social media platforms (META, YouTube, TikTok, etc.).</li><li>Basic understanding of project coordination or product development processes.</li><li>Strong willingness to learn and ability to work in a fast-paced environment.</li><li>Ability to work effectively in a collaborative environment with multi-functional teams.</li><li>Good communication skills (spoken and written) in English and Thai.</li><li>Proactive, responsible, and able to manage tasks with guidance from seniors.</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: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

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145 central engineering Jobs found

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

Assistant Brand and Innovation Project Manager (Contractual)

Senior Project Management Engineer

QE Specialist

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145 central engineering Jobs found

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Senior Manager Channel Sales

Quality Improvement Manager

Senior Quality & Reliability Engineer

Assistant Brand and Innovation Project Manager (Contractual)

Senior Project Management Engineer

QE Specialist

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