Packaging Technician

Service Technician

Service Coordinator

Maintenance Manager

Senior / Lead Maintenance Technician

Production Manager - Cable Making Business

Facilities Supervisor

Distribution Resource Planner

Staff Advanced Quality Engineer (Software)

Inspection Technician

Role Description: <ul><li>The Production Technician II is an advanced-level technician role responsible for sterile pharmaceutical manufacturing operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.</li><li>This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures. </li><li>The Production Technician II serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.</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 <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.</li><li>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: Commissioning &amp; Startup: <ul><li>Installing new UPS systems and energy storage solutions at client sites.
</li></ul> Preventive &amp; Corrective Maintenance:: <ul><li>Conducting battery replacements, system audits, and component repairs to maintain high availability.</li></ul> Troubleshooting: <ul><li>Diagnosing complex electrical and software issues on critical power systems.</li></ul> Customer Support: <ul><li>Delivering technical feedback, creating service reports, and offering solutions to meet customer needs.</li></ul> Safety Compliance: <ul><li>Ensuring all work complies with health and safety standards. </li></ul> Requirements: <ul><li>Technical Education: Background in electrical engineering or equivalent technical field.</li><li>Experience: Previous experience with UPS or power electronics, with roles ranging from entry-level to experienced technicians.</li><li>Skills: Strong diagnostic ability, proficiency with diagnostic tools, and customer service skills.</li><li>Travel: Ability to travel to customer sites as needed</li></ul>

Responsibilities: <ul><li>Coordinate monthly contract visits (report extraction, customer contact, scheduling, job creation and report distribution).</li><li>Manage off contract maintenance visits and reactive call outs.</li><li>Support service contracts, ensuring compliance with SLAs.</li><li>Assist with accounts receivable/payable processes related to service activities.</li><li>Handling of incoming calls and other communications related to service activities.</li><li>Processing of orders to factories and 3rd party suppliers, administration of payables to suppliers in collaboration with our Singapore-based accounts team.</li><li>Support processing of customer purchase orders, delivery dockets to the warehouse and invoicing of clients through ERP SAP B1.&nbsp;</li></ul> Requirements: <ul><li>Relevant experiences with order processing</li><li>1-3 years’ experience in administration / reception</li><li>Experience as a coordinator within service-related industry</li></ul>

Responsibilities: Preventive Maintenance &amp; Operations: <ul><li>Coordinate with Production Scheduling and Value Stream teams to plan PM activities at least 72 hours in advance</li><li>Develop and manage PM schedules within CMMS systems</li><li>Ensure PMs include tasks, BOM, OEM manuals, images, and execution details</li><li>Establish PM audit processes to ensure effectiveness</li><li>Implement visual systems to communicate PM schedules to production teams</li><li>Track and report PM performance metrics (On-Time completion, Schedule Adherence)</li><li>Ensure proper closure of PM work orders to support MTBF, MTTR, and reliability improvements</li><li>Develop PM kitting processes to improve efficiency</li></ul> Leadership &amp; Team Management: <ul><li>Lead, mentor, and manage maintenance teams</li><li>Recognize and reward employee performance</li><li>Drive adherence to company policies and operational procedures</li><li>Support hiring, staffing, and equal opportunity practices</li><li>Conduct performance evaluations and identify training needs</li></ul> Safety, Compliance &amp; Continuous Improvement: <ul><li>Ensure compliance with OSHA, PPE, plant safety systems, ISO, and TS 16949 standards</li><li>Lead TPM initiatives and continuous improvement programs</li><li>Ensure timely completion of safety and quality engagement activities</li></ul> Budget &amp; Stakeholder Management: <ul><li>Manage departmental budgets and cost-saving initiatives</li><li>Prepare reports, maintain records, and handle communications</li><li>Collaborate with external suppliers and OEMs for technical support and training</li></ul>&nbsp;Requirements: Education &amp; Experience: <ul><li>Associate’s Degree + 8+ years of maintenance &amp; leadership experience</li><li>OR</li><li>Bachelor’s Degree in Engineering + 5+ years of experience</li><li>OR</li><li>Equivalent combination of education and experience</li></ul> Technical Expertise: <ul><li>Minimum 5 years of CMMS/database administration experience (Maximo, MP2, Maintenance Connection, eMaint)</li><li>Strong technical writing and documentation skills</li><li>Deep knowledge of maintenance systems, tools, and methodologies</li></ul> Hands-On Experience With: <ul><li>PLC systems</li><li>Electric motors and controllers</li><li>Mechanical, pneumatic, and hydraulic systems</li><li>Vacuum pumps and plant equipment</li></ul> Preferred Skills: <ul><li>Microsoft Office (Excel, Word, Outlook)</li><li>Lean Manufacturing, Six Sigma, 5S (Green Belt preferred)</li><li>Understanding of MTBF, MTTR, and TPM programs&nbsp;</li></ul>

Position Summary: <ul><li>The Senior Maintenance Technician will lead maintenance activities in a GMP-regulated pharmaceutical manufacturing environment, ensuring reliable operation of production and facility systems.&nbsp;</li><li>This role focuses on equipment uptime, preventive maintenance, troubleshooting, and continuous improvement of utilities and process equipment—including tablet presses, granulation systems, and HVAC systems supporting cleanroom operations.</li></ul> Responsibilities: <ul><li>Perform and oversee preventive, predictive, and corrective maintenance on pharmaceutical manufacturing and facility equipment.</li><li>Lead troubleshooting and repair efforts on tablet presses, granulators, blenders, fluid bed dryers, coating machines, and other process equipment.</li><li>Maintain and repair facility utilities such as HVAC systems, compressed air, purified water, steam, chilled water, and vacuum systems.</li><li>Support calibration and mechanical integrity programs to ensure GMP compliance.</li><li>Collaborate with Production, Engineering, and Quality departments to minimize downtime and ensure regulatory requirements are met.</li><li>Review and update maintenance SOPs, work orders, and documentation in accordance with cGMP and FDA standards.</li><li>Train and mentor junior technicians and provide technical guidance during shifts or project work.</li><li>Participate in capital projects, equipment installation, and commissioning/qualification activities (IQ/OQ/PQ).</li><li>Identify and implement process improvements to increase reliability and reduce maintenance costs.</li><li>Support environmental monitoring and cleanroom operation standards through proper maintenance of HVAC and filtration systems.</li></ul> Requirements: <ul><li>Associate’s or Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering (or equivalent technical discipline) preferred.</li><li>Experience: Minimum 5–8 years in a maintenance or engineering role within a pharmaceutical, biotech, or GMP manufacturing environment.</li><li>Strong hands-on experience with tablet compression, granulation, and packaging equipment.</li><li>Working knowledge of HVAC systems, cleanroom environments, and associated regulatory requirements (ISO 14644, cGMP).</li><li>Familiarity with CMMS systems (e.g.,, BMRAM, Maximo, SAP PM) and maintenance documentation practices.</li><li>Strong understanding of electrical, mechanical, and pneumatic systems.</li><li>Excellent problem-solving, communication, and leadership skills.</li></ul> Preferred Skills: <ul><li>Knowledge of PLCs and control systems troubleshooting.</li><li>Experience with aseptic or sterile manufacturing utilities.</li><li>Understanding of 21 CFR Part 11 and data integrity principles.</li><li>Root cause analysis and reliability-centered maintenance experience. Key Responsibilities</li></ul>

Responsibilities: Policies, Compliance &amp; Governance <ul><li>Develop and implement manufacturing policies and procedures in compliance with company standards, regulatory requirements, and customer-specific requirements (e.g., automotive, industrial).</li><li>Ensure full alignment with the organization principles and drive governance across production operations.</li><li>Establish clear roles, responsibilities, and accountability to support a high-performance culture.</li><li>Drive compliance in EHS, quality systems, and corporate policies.</li></ul> Strategy, Demand &amp; Capacity Planning <ul><li>Lead SIOP (Sales, Inventory &amp; Operations Planning) alignment with cross-functional teams (planning, procurement, engineering).</li><li>Own demand forecasting translation into executable production plans.</li><li>Drive capacity planning, including labor, equipment, and tooling readiness for NPI and ramp.</li><li>Develop and manage annual operating plans (AOP), budgets, and KPI targets aligned with plant and segment goals.</li></ul> Production Planning &amp; Execution <ul><li>Oversee detailed production scheduling to meet customer delivery (OTD) and lead-time targets.</li><li>Ensure seamless coordination between planning, material availability, and shopfloor execution.</li><li>Drive daily management using tiered accountability (e.g., SQDC boards) to close gaps quickly.</li><li>Lead ramp readiness and execution for new programs and volume increases.</li></ul> Operations &amp; Value Stream Management <ul><li>Lead Value Stream (VS) performance to achieve Safety, Quality, Delivery, and Cost (SQDC) targets.</li><li>Drive operational excellence through Lean Manufacturing and company tools (e.g., VSM, QCO, standard work, visual management).</li><li>Ensure strong quality control and assurance, including FPY, scrap reduction, and customer complaint resolution.</li><li>Lead structured problem-solving (8D, A3) for manufacturing and quality issues.</li><li>Ensure STR (Short-Term Recovery) discipline for gap closure.</li></ul> Inventory, Materials &amp; Resource Optimization <ul><li>Drive inventory management aligned with company working capital targets (DOH, turns).</li><li>Ensure material availability while minimizing excess and obsolescence.</li><li>Optimize resource allocation (labor, equipment, floor space) to maximize productivity and efficiency.</li></ul> Cost Management &amp; Productivity <ul><li>Own and deliver cost commitments including productivity, conversion cost, and budget adherence.</li><li>Drive cost reduction through Kaizen, waste elimination, labor productivity, and process optimization.</li><li>Support make vs. buy decisions and footprint optimization where applicable.</li></ul> Maintenance &amp; Equipment Reliability <ul><li>Partner with Maintenance and Engineering to ensure high equipment uptime (OEE focus).</li><li>Implement preventive and predictive maintenance systems aligned with company standards.</li><li>Support equipment qualification, automation, and digitalization initiatives.</li></ul> People Leadership &amp; Talent Development <ul><li>Build and lead a high-performing, engaged production team.</li><li>Develop frontline leaders (supervisors, VS leaders) in Lean, and leadership capability.</li><li>Drive performance management, succession planning, and talent retention.</li><li>Foster a culture of accountability, continuous improvement, and employee engagement.</li></ul> Continuous Improvement &amp; Deployment <ul><li>Lead and sustain company deployment across production areas.</li><li>Execute continuous improvement initiatives (Kaizen, Tebit savings, CI projects) to improve SQDC performance.</li><li>Promote best practice sharing across value streams and plants.</li></ul> Technology &amp; NPI Support <ul><li>Collaborate with Engineering on NPI, process validation, and industrialization.</li><li>Support DFM/DFA and process capability improvement.</li><li>Drive adoption of new manufacturing technologies and automation to enhance competitiveness.</li></ul> Operational Flexibility <ul><li>Demonstrate flexibility to support shift operations, ramp-up activities, and critical business needs, including off-hours leadership presence when required.</li></ul> Requirements: <ul><li>Min 8-10 years working experience in an MNC with responsibilities in production operations.&nbsp;</li><li>Strong exposure to Contract Manufacturing operations.&nbsp;</li><li>SAP knowledge is an added advantage.&nbsp;</li><li>Cable manufacturing exposure is an added advantage.&nbsp;</li><li>Proven ability in People Management.&nbsp;</li><li>Hands-on experience in NPI, ramp up activities, and continuous improvement initiatives.&nbsp;</li><li>Demonstrated team leadership skills with the ability to drive operational excellence.</li><li>Travelling 20% required for product knowledge transfer.</li><li>Fluent in English &amp; Malay (verbal and written)</li></ul>

Responsibilities : <ul><li>Supervise day-to-day facility operations, including building, equipment, utilities ,and grounds maintenance.&nbsp;</li><li>Manage preventive and corrective maintenance programs to minimize downtime and ensure safety.&nbsp;</li><li>Oversee contractors, vendors, and service providers to ensure quality, cost effectiveness, and compliance with standards.&nbsp;</li><li>Ensure facilities comply with local regulations, EHS standards, and corporate sustainability goals.&nbsp;</li><li>Support plant operations by ensuring reliable supply of utilities such as electricity ,water, compressed air, and HVAC systems.&nbsp;</li><li>Lead and develop a team of technicians to drive efficiency, safety, and continuous improvement.&nbsp;</li><li>Prepare and monitor facility budgets, expenses, and project timelines.&nbsp;</li><li>Manage emergency response plans and support safety initiatives across the site.&nbsp;</li><li>Drive facility improvement projects, including space planning, energy efficiency, and workplace optimization.</li></ul> Requirements: <ul><li>Diploma/Degree in Mechanical, Electrical, Facilities Management, or related field.&nbsp;</li><li>Minimum 5 years of facilities management/maintenance experience, preferably in a manufacturing environment.&nbsp;</li><li>Strong knowledge of EHS compliance, building systems, utilities, and facility operations.&nbsp;</li><li>Proven experience supervising teams and managing external contractors/vendors.&nbsp;</li><li>Strong problem-solving, organizational, and project management skills.&nbsp;</li><li>Good communication skills in English and Bahasa Malaysia.</li></ul>

Role Description:&nbsp;&nbsp; <ul><li>The Distribution Resource Planner works alongside the Regional Distribution Planner in guaranteeing uninterrupted supply to customers and/or our client sites by balancing supply, demand and inventory.&nbsp;</li><li>The role serves in active partnership on all supply related questions from business partners (BO Management, Demand Manager, Product Quality, Sales, Logistics, Customers Service, Manufacturing and Supply Planner).&nbsp;</li><li>This person will work closely with Global planning and functionally reports to the Supply Chain Manager.&nbsp;</li></ul> Responsibilities:&nbsp; <ul><li>Inventory: Responsible for administration around inventory movements, manage inventory levels and replenishment orders,you manage aged &amp; blocked inventories, relabeling.&nbsp;</li><li>Furthermore, responsible for monthly reconciliations of inventory levels stored at 3rd party warehouses and consignment.&nbsp;&nbsp;</li></ul> <ul><li>Planning: Monitor the 6-month rolling supply plan for imported products as assigned aligned with the regional planner,understand and execute the key analytics in line with the supply processes to ensure optimal demand &amp; supply balance.&nbsp;</li><li>This includes for example coordination on the drumming schedule and vessel arrangements.&nbsp;&nbsp;</li></ul> <ul><li>Projects &amp; Coordination: Initiate improvement opportunities (processes, tools and knowledge) and support implementation of these pro-actively, including optimization of shipment modes, loads and packaging based on costs and inventory.&nbsp;</li></ul>&nbsp;<ul><li>Reporting: Assume responsibility for effective and timely Analysis and Reporting, analyze demand data and measure forecast accuracy, support in the evaluation and maintenance of Safety Stock and Target Inventory numbers for the region and ensures full compliance with Corporate Standard Operating Procedures and all Sarbanes Oxley required processes&nbsp;</li></ul> <ul><li>Safety - Comply with our client safety and wellness musts, complete required HSES trainings through TEDS.&nbsp;Actively engage and promote activities that will enhance safety culture&nbsp;&nbsp;</li></ul> <ul><li>Short Term Planning - Develop and maintain the 6-12 month rolling supply plan for assigned product lines and be an active partner on all supply questions for business partners (BU Management, Demand Managers, Sales, Logistics, Customer Service and Supply Planners)&nbsp;&nbsp;</li></ul> <ul><li>Long Term Planning - Actively supports the Supply Manager in developing the 24 month supply plan for assigned product lines.&nbsp;&nbsp;</li></ul> <ul><li>Demand Verification - Analyze (6 month) demand data, measure forecast accuracy, take appropriate actions, engage with commercial team on forecast changes and document/report out on those&nbsp;&nbsp;</li></ul> <ul><li>Analytics - Understand and execute the key analytics in line with the supply processes to achieve optimal demand &amp; supply balance (re-ordering strategy and execution, reacting to changes in demand)&nbsp;&nbsp;</li></ul> <ul><li>OPEX - Participate in regional (OpEx) meetings that are being held for the business planning for&nbsp;Metrics - Develop, maintain and review inventory measures and take appropriate actions (a.o. safety stock review, dead stock review, 60-100 day file, EEOA, DQO). Review, understand, and drive improvement in HOC metrics (Metric Pack)&nbsp;&nbsp;</li></ul> <ul><li>Master Data - Master data analysis and maintenance, reviewing the settings against ever changing environment and achieve right master data settings to enable best planning results&nbsp;&nbsp;</li></ul> <ul><li>Knowledge - Actively seeks to increase product and market knowledge, Understand business and product strategies for the product range covered&nbsp;&nbsp;</li></ul> <ul><li>Reconciliations - Responsible for monthly reconciliations of inventory levels stored at 3rd party warehouses and ensuring appropriate approvals for adjustments&nbsp;&nbsp;</li></ul> Requirements: Basic Qualifications:&nbsp; <ul><li>Bachelor or Master degree in Logistics, Supply Chain or Industrial Engineering or related business fields is required&nbsp;</li><li>APICS CPIM or comparable certification is a strong pre, demonstrated experience with planning &amp; inventories&nbsp;&nbsp;</li><li>Minimum of 3 years of Planning or Supply Chain experience in an International environment&nbsp;</li><li>Good analytical skills&nbsp;</li><li>Advanced Excel skills&nbsp;</li><li>Fluent in English is required, both verbal and written.</li><li>Additional languages are a plus Preferred Qualifications:&nbsp;&nbsp;</li><li>Experience with SAP / ERP system is a plus.&nbsp;&nbsp;</li><li>Work structured and methodologically in a constant changing environment&nbsp;</li><li>Self-starter, results orientated and independent thinker – always looking for improvement opportunities&nbsp;</li><li>Ability to assemble info to make a big picture, while also able to dive into the underlying details&nbsp;</li><li>Customer focused, pro-active&nbsp;</li><li>Adhere to health, safety and environmental policies and procedures to ensure the safety and wellbeing of self, other staff and visitors</li></ul>

Responsibilities: QMS Ownership for Deliverable Software <ul><li>Translate AS9115 Rev A and AS9100:2016 requirements into practical procedures, work instructions, and templates.</li><li>Establish processes covering software planning, development, integration, verification/validation, release, delivery, and post-delivery support.</li><li>Ensure the QMS supports multiple development models (Agile, Waterfall, Incremental) while enforcing required quality controls including reviews, approvals, traceability, and documentation.</li></ul> Software Planning &amp; Requirements Quality <ul><li>Lead the creation and maintenance of Software Quality Plans.</li><li>Establish standards for requirements management ensuring requirements are:</li></ul> <ul><li>Clear</li><li>Unambiguous</li><li>Testable</li><li>Maintain bidirectional traceability from:</li><li>Requirements → Design → Code → Test → Release.</li></ul> Configuration Management &amp; Change Control Define standards for Software Configuration Management (CM) including: <ul><li>Baselines</li><li>Configuration item identification</li><li>Change evaluation and approval</li><li>Configuration status accounting</li><li>Integrate software configuration management with product and system configuration processes.</li><li>Ensure CM covers software, documentation, tools, environments, and build/release artifacts.</li></ul> Supplier &amp; COTS/NDS Management <ul><li>Establish standards for evaluation and acceptance of Commercial Off-The-Shelf (COTS) and Non-Developmental Software (NDS) used in deliverable products.</li><li>Define AS9115 control applicability with both customers and suppliers.</li><li>Support supplier qualification, audits, and incoming verification for software deliverables and services.</li></ul> Verification, Validation &amp; Test Assurance <ul><li>Define verification standards within the QMS including:</li><li>Static analysis</li><li>Peer reviews</li><li>Unit testing</li><li>Integration testing</li><li>System testing</li><li>Regression testing</li><li>Security testing</li><li>Ensure independence of verification activities where required.</li><li>Maintain controlled test environments, data integrity, and objective evidence for compliance audits.</li></ul> Release, Delivery &amp; Post-Delivery Support Develop procedures for: <ul><li>Software release criteria</li><li>Delivery records</li><li>Installation documentation</li><li>Post-delivery issue management</li><li>Patching and configuration updates</li><li>Ensure all processes align with AS9115 standards.</li></ul> Audits, Metrics &amp; Continuous Improvement Lead internal and customer audits related to AS9115/AS9100 compliance. <ul><li>Manage Corrective and Preventive Actions (CAPA).</li><li>Support external and second-party audits with aerospace OEMs.</li><li>Define and track key quality KPIs, including:</li><li>Requirements volatility</li><li>Defect density</li><li>Defect escape rate</li><li>Verification coverage</li><li>Audit findings aging</li><li>Build reproducibility</li><li>Change lead time</li></ul> Requirements: Bachelor’s or Master’s degree in: <ul><li>Software Engineering</li><li>Computer Science</li><li>Systems Engineering or a related discipline.</li><li>Minimum 5 years of experience in software quality or software engineering within aerospace, defense, or other regulated industries.</li><li>Hands-on experience implementing AS9100 quality processes with working knowledge of AS9115 software lifecycle controls.</li></ul> Strong experience in: <ul><li>Requirements management</li><li>Configuration management</li><li>Verification and validation</li><li>Software release governance</li><li>Experience managing COTS/NDS software integration and supplier quality.</li><li>Proven ability to lead audit activities and corrective actions using structured problem-solving tools such as:</li><li>5 Why</li><li>Ishikawa</li><li>8D</li></ul> Preferred Qualifications <ul><li>Experience supporting AS9115 second-party audits with aerospace OEMs.</li><li>Familiarity with DO-178C concepts and coordination with DO-254/ED-80 hardware processes.</li><li>Experience with ALM/PLM and configuration management tools, such as:</li><li>Polarion</li><li>IBM DOORS</li><li>CodeBeamer</li><li>Git / GitLab</li><li>Bitbucket</li><li>Azure DevOps</li><li>Knowledge of CI/CD pipelines, static analysis tools, and unit testing frameworks.</li><li>Exposure to CMMI-DEV processes and experience aligning them with AS9115 quality objectives.</li></ul>

Role Description: <ul><li>Purpose Statement The Inspection Technician is responsible for sterile pharmaceutical inspection operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.</li><li>This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures.</li><li>The Inspection Technician serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.</li><li>This position will include cross training for support of formulation, IV Bag filling, leak inspection, dispensing and packaging.</li></ul> Responsibilities: <ul><li>Operate, monitor, and adjust IV Bag inspection equipment and direct 100% inspection of filled IV-bags of various sizes and configuration.</li><li>Secondary responsibilities will include operating manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform visual inspection of final product to ensure conformance with quality standards and specifications.</li><li>Perform AQL testing manually to verify integrity of the automated inspection system.</li><li>Serve as first-line troubleshooting support for equipment and GMP manufacturing 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 other production 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>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 product post fill inspection.</li><li>Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with skills including the ability to concisely describe problems to mechanics.</li><li>Knowledge of cGMP, and aseptic processing, requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI required. Experience with a supervisory controller and data acquisition system (SCADA) interface will be a plus.</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>Precise skills for inspecting finished product effectively.</li><li>Demonstrated problem-solving and 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>Comfortable working in cleanroom environments with PPE requirements.</li></ul>

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67 maintenance Jobs found

Packaging Technician

Service Technician

Service Coordinator

Maintenance Manager

Senior / Lead Maintenance Technician

Production Manager - Cable Making Business

Facilities Supervisor

Distribution Resource Planner

Staff Advanced Quality Engineer (Software)

Inspection Technician

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67 maintenance Jobs found

Packaging Technician

Service Technician

Service Coordinator

Maintenance Manager

Senior / Lead Maintenance Technician

Production Manager - Cable Making Business

Facilities Supervisor

Distribution Resource Planner

Staff Advanced Quality Engineer (Software)

Inspection Technician

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