Mechatronics Engineer

Logistics Supervisor

Logistics Analyst

Maintenance Engineer

Procurement Operations Manager

Production Technician I

Quality Technician

Manager - Environmental Health & Safety (EHS)

Quality Associate I

Compounding Technician

Role Description: <ul><li>The Position has been created to lead a team of Mechanical Designers, Electrical Automation Engineers and Technicians of the Operations team to define the process and build the machines needed to make the new products in line with the strategy map and market demand.</li></ul> Responsibilities: <ul><li>Responsible for working with a team of engineers for new project launches. Coordination with different technology leads connected with new projects. Collaborating with ME, OPS, AQE, NPI and PLTL team for execution of all new projects as per agreed APQP timelines.</li><li>Responsible for execution of PLTL projects and adherence to launch sheet requirements.</li><li>End to End responsible for capturing the voice of Customers and All Stakeholder requirements of the product to meet the expectations</li><li>Act as a purposeful bridge between ME and operations.</li><li>Work closely with project management and NPI procurement for capacity and streamlined supplies&nbsp;</li><li>Identify safety, quality and cost saving opportunities on new and existing projects.</li></ul> Requirements: <ul><li>Technical Degree/Diploma in Mechatronics - NTTF/BE</li><li>Hands own experience assembly of machines and troubleshooting</li><li>1 to 4+ years of experience working in medium or large matrix organizations.&nbsp;</li><li>Hands on Experience in designing and building Complex and high precision machines, high accuracy assembly automation machines for Automotive or electronics industries</li><li>Experience in Robot programming.</li><li>Vision inspection and testing machines like leakage testers and electrical testers experience&nbsp;</li><li>PLC and HMI Programming, Servo programming and tuning, and trouble shooting</li><li>Updated knowledge on current Programming Software and Design Software.</li></ul>

Responsibilities: Team Leadership and Management <ul><li>Lead and supervise logistics and Imports/Exports teams, providing guidance, training, and support to ensure efficient execution of all logistics activities.</li><li>Foster a positive team culture that promotes collaboration, continuous learning, and operational excellence.</li></ul> Shipment and Freight Coordination <ul><li>Oversee the scheduling and coordination of inbound and outbound shipments to meet production and customer requirements.</li><li>Coordinate international shipments from all regions to Latin America, maintaining close communication with service providers to track orders and ensure service level compliance.</li></ul> Warehouse and Plant Operations <ul><li>Manage warehouse and plant logistics operations to ensure efficient material flow and optimal inventory handling.</li><li>Monitor and control distribution and logistics-related costs.</li></ul> Cross-functional Collaboration and Project Management <ul><li>Collaborate with cross-functional teams to develop and implement logistics strategies aligned with organizational objectives.</li><li>Coordinate supply chain projects and/or lead logistics team members in managing regional initiatives within the LAR region.</li><li>Work closely with internal stakeholders, external partners, and regulatory authorities to ensure project objectives are achieved, including but not limited to:</li><li>New Resale Operations: Assess feasibility and support implementation, ensuring supply chain efficiency and regulatory compliance.</li><li>Transportation Mode Expansion: Evaluate alternative transportation modes (e.g., cabotage) to optimize routes and reduce costs.</li><li>Warehousing Projects: Support the establishment and management of warehouses, ensuring compliance with regulations and efficient storage and distribution.</li><li>Market Analysis: Conduct research to identify logistics trends, opportunities, and potential partnerships.</li><li>Project Planning: Develop project plans, budgets, and timelines, ensuring effective execution.</li><li>Risk Assessment: Identify potential risks and propose mitigation strategies.</li><li>Documentation and Compliance: Ensure all permits, licenses, and documentation are obtained and maintained in line with regional and international regulations.</li><li>Reporting and Evaluation: Monitor project progress, report results, and evaluate business impact on logistics and supply chain operations.</li></ul> Compliance and Safety <ul><li>Manage the Imports/Exports team responsible for customs clearance, international transportation, and trade documentation.</li><li>Collaborate with external customs brokers to ensure accurate and timely submission of documentation.</li><li>Ensure full compliance with regulatory, trade, and company standards.</li><li>Support internal and external audits by providing accurate and timely information.</li><li>Promote safety by ensuring compliance with all applicable safety standards and legal requirements.</li></ul> Supplier and Service Provider Management <ul><li>Maintain regular communication with logistics suppliers and service providers.</li><li>Review supplier performance, investigate and resolve shipment-related issues, and ensure timely and reliable deliveries.</li></ul> Cost Control and Reporting <ul><li>Prepare and analyze logistics and trade-related reports, providing insights and recommendations to senior management.</li><li>Utilize data analytics and predictive tools to optimize logistics operations strategically.</li><li>Manage logistics process documentation and flowcharts with a focus on continuous improvement, productivity, and cost efficiency.</li></ul> Requirements: <ul><li>Bachelor’s degree in Supply Chain Management, Business, Engineering, or a related field (preferred).</li><li>Solid experience in logistics and/or other supply chain functions, including a minimum of 3 years in a leadership role.</li><li>Strong knowledge of customs regulations and logistics operations, including transportation, distribution, and warehousing.</li><li>Proven experience in global logistics operations, international trade, or supply chain management.</li><li>Excellent communication and interpersonal skills to work effectively with internal teams, external partners, and government authorities.</li><li>Strong analytical skills with the ability to interpret data, identify trends, and make informed decisions.</li><li>Proficiency in ERP systems (e.g., SAP) for logistics and trade management.</li><li>Detail-oriented mindset with a strong focus on accuracy and compliance.</li><li>Demonstrated problem-solving abilities to address operational challenges and implement effective solutions.</li><li>Professional certifications such as Six Sigma (Green or Black Belt), ISO 9001, Lean Management, APICS CSCP, or PMP are desirable.</li><li>Fluency in Portuguese and English is required; proficiency in Spanish is an advantage.</li></ul>

Responsibilities: Transportation Management <ul><li>Schedule and coordinate inbound and outbound transportation activities.</li><li>Monitor transportation providers’ performance to ensure on-time and cost-effective deliveries.</li><li>Optimize routing and logistics strategies to minimize transportation costs and improve efficiency.</li></ul> Warehouse Communication <ul><li>Maintain regular communication with warehouse teams to ensure timely receipt, storage, and dispatch of materials.</li><li>Conduct audits and inventory reviews to ensure accuracy and compliance.</li><li>Collaborate with warehouse teams to resolve discrepancies, delays, or operational issues.</li></ul> Material Handling <ul><li>Oversee the receipt, inspection, and verification of materials.</li><li>Coordinate proper storage, handling, and retrieval of materials.</li><li>Ensure compliance with safety, quality, and operational standards.</li></ul> Billing and Invoicing <ul><li>Manage logistics-related billing processes, ensuring invoice accuracy and completeness.</li><li>Investigate and resolve billing discrepancies with suppliers and service providers.</li><li>Maintain accurate records of invoices, payments, and related documentation.</li></ul> Customer Complaint Resolution <ul><li>Address customer complaints related to logistics and supply chain operations in a timely and professional manner.</li><li>Conduct root cause analysis and implement corrective and preventive actions.</li><li>Collaborate with customer service and internal teams to ensure customer satisfaction.</li></ul> Automation Processes <ul><li>Develop and implement automation solutions, including macros, robots, and custom code, to improve logistics and supply chain processes.</li><li>Identify opportunities for automation, process optimization, and efficiency improvements.</li><li>Collaborate with cross-functional teams to integrate automation solutions across systems and operations.</li></ul> Dashboard Development and Maintenance <ul><li>Design, develop, and maintain dashboards using tools such as Power BI and Power Automate to track key performance indicators (KPIs).</li><li>Ensure data accuracy, consistency, and relevance in reports and dashboards.</li><li>Work with stakeholders to gather requirements and support data-driven decision-making.</li></ul> Safety and Compliance <ul><li>Respond to internal and external audits, ensuring accurate and timely compliance reporting.</li><li>Ensure adherence to company policies, local regulations, and international standards related to transportation and storage.</li><li>Promote and maintain compliance with all applicable safety, legal, and regulatory requirements.</li></ul> Business Development and Project Coordination <ul><li>Participate in and coordinate regional strategic business development initiatives, including but not limited to:</li><li>New Resale Operations: Assess feasibility and support implementation of new resale operations in collaboration with cross-functional teams.</li><li>Transportation Mode Expansion: Evaluate alternative transportation modes, such as cabotage, to improve efficiency and reduce costs.</li><li>Warehouse Operations: Support the establishment and management of warehouses, ensuring regulatory compliance and operational efficiency.</li><li>Market Analysis: Conduct market research to identify trends, opportunities, and potential partnerships aligned with supply chain growth objectives.</li><li>Project Planning: Develop project plans, budgets, timelines, and track execution with key stakeholders.</li><li>Risk Assessment: Identify risks associated with new initiatives and propose mitigation strategies.</li><li>Documentation and Compliance: Ensure all required permits, licenses, and regulatory documentation are obtained and maintained.</li><li>Stakeholder Collaboration: Work with internal teams, external partners, and government agencies to facilitate approvals and successful implementation.</li><li>Reporting and Evaluation: Monitor, report, and evaluate project performance and its impact on logistics and supply chain operations.</li></ul>&nbsp;Requirements: Qualifications <ul><li>Bachelor’s degree in Logistics, Engineering, Supply Chain Management, or a related field (preferred).</li><li>Proven experience in logistics, transportation, or supply chain operations.</li><li>Strong analytical, problem-solving, and organizational skills.</li><li>Excellent communication and interpersonal abilities.</li><li>Knowledge of quality management systems and standards (ISO 9000, ISO 14000, IATF, etc.).</li><li>Proficiency in logistics systems and Microsoft Office applications.</li><li>Hands-on experience with automation tools, macros, custom code, and dashboard development using Power BI and Power Automate.</li><li>Ability to work in a fast-paced environment and manage multiple priorities effectively.</li><li>Supply chain certifications (CSCP, CPSM, or similar) are an advantage.</li><li>Fluency in Portuguese and English is required; Spanish proficiency is a plus</li></ul>

Role Description:&nbsp; <ul><li>To lead and manage Electrical, Electronics, PLC, and Mechanical maintenance activities across processing and packing assets.&nbsp;</li><li>The role is responsible for ensuring safe, reliable, and efficient operation of equipment by eliminating electrical, automation, mechanical, and process-related. breakdowns, improving equipment reliability and OEE, and strategically reducing unplanned downtime through effective maintenance execution and team leadership.&nbsp;</li></ul> Responsibilities: <ul><li>Lead, coordinate, and manage both Electrical and Mechanical Maintenance teams.&nbsp;</li><li>Provide hands-on technical leadership for electrical, electronics, PLC, and mechanical breakdowns.&nbsp;</li><li>Manage preventive, corrective, and condition-based maintenance activities across all processing and packing equipment.&nbsp;</li><li>Troubleshoot PLC-controlled systems including fault diagnostics, I/O checks, sensors, actuators, and basic logic analysis.&nbsp;</li><li>Oversee mechanical maintenance activities including rotating equipment, conveyors, gearboxes, bearings, and drive systems.&nbsp;</li><li>Guide maintenance teams in root cause analysis (RCA), loss analysis, and implementation of permanent corrective actions.&nbsp;</li><li>Ensure effective maintenance planning, execution, and reporting through SAP PM.&nbsp;</li><li>Own and maintain electrical, automation, and mechanical spare parts inventories, ensuring availability of critical spares.&nbsp;</li><li>Develop maintenance standards, work instructions, and OPLs for electrical, PLC, and mechanical activities.&nbsp;</li><li>Support technician capability development through coaching and technical training (electrical, PLC, and mechanical).&nbsp;</li><li>Ensure compliance with EHS, QFS, and machinery safety standards during all maintenance activities.&nbsp;</li><li>Maintain accurate documentation and records to support internal and external audits (EHS, QFS, KWS, FSSC, etc.).&nbsp;</li></ul> Key Performance Indicators (KPIs):&nbsp; <ul><li>Reduction of unplanned downtime.&nbsp;</li><li>Improvement of equipment reliability and OEE.&nbsp;</li><li>Preventive maintenance on-time completion rate.</li><li>Breakdown response time and MTTR.&nbsp;</li><li>Maintenance cost control and spare parts availability.&nbsp;</li><li>Electrical and Mechanical team capability development.&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical &amp; Electronics Engineering or Mechatronics Engineering.&nbsp;</li><li>Minimum 5 years of maintenance experience in manufacturing or FMCG environments.&nbsp;</li><li>Proven experience in leading both electrical and mechanical maintenance teams.&nbsp;</li><li>Strong knowledge of industrial electrical, electronic, automation, and mechanical systems.&nbsp;</li><li>Mandatory PLC knowledge : - Fault finding and diagnostics - I/O modules, field devices, and communication basics - Ability to read and analyze PLC logic&nbsp;</li><li>Solid mechanical knowledge including rotating equipment, gearboxes, bearings, conveyors, and power&nbsp;transmission systems.&nbsp;</li><li>Experience with motors, inverters, servo drives, sensors, actuators, and control systems.&nbsp;</li><li>Experience with SAP PM or similar CMMS systems.&nbsp;</li><li>Strong leadership, problem-solving, communication, and decision-making skills.</li></ul>

Responsibilities: Primary Function : <ul><li>Lead the procurement function for Pringles plant at Bandar Enstek, Malaysia. Act as focal point between regional procurement and local plant team</li><li>Manage all local procurement activities, including ad hoc sourcing, negotiations and contracting for items not in scope for regional category manager, issue resolution, local supplier management, shipment expediting, materials claim management and etc.</li><li>Support the sourcing strategy of the regional and global procurement sourcing team.</li><li>Connect plant stakeholders with MSP (managed service provider) for IDM STP support (Source-to-PO)</li><li>Advocate the global procurement policies (GPP) and responsible to educate the BU requesters on the GPP policy and compliances</li><li>Work with BU stakeholders, Category Managers, Process and Systems Lead, Procurement Operations Lead to identify efficiency and cost reduction opportunities</li><li>Manage supplier relationship and performance</li></ul> Principal Duties &amp;&nbsp;Responsibilities : <ul><li>Deliver upon targets and KPIs set by snacks supply chain and regional procurement</li><li>Attend plant supply chain deployment meetings</li><li>Comply with GMP and continuously improve our Food Safety Programme</li><li>Participate in Regional Sourcing activities and ensure regional / local execution knowledge and strategic input</li><li>Lead the execution and implementation of procurement sourcing strategy</li><li>Leverage regional procurement team to drive values</li><li>Aid in local supplier searches</li><li>Manage interactions with key suppliers</li><li>Manage financial reporting of procurement function</li><li>Manage transactional coordinators and balances workload within the team</li><li>Ensure compliance with policies and procedures</li><li>Deliver policy and process trainings to key stakeholders</li><li>Work closely with key customers to communicate process</li><li>Use data from Process and Systems team to set targets and drive KPIs</li><li>Work with shared services to standardize and automate tactical activities over time</li><li>Suppliers KPIs and service quality and performance improvement plan</li></ul> Requirements: Professional : <ul><li>Undergraduate Degree Required and minimum of 7 years of related work experience within Procurement</li></ul> Technical/Functional: <ul><li>More of Procurement generalist than a specialist.</li><li>Knowledge of order to payment technologies (P2P, SAP) and other procurement digital tools.</li><li>Sound procurement skills (negotiation, supplier management).</li><li>General knowledge of the supplier market in associated country.</li><li>Comprehensive knowledge of purchasing and basic understanding of supply chain management.</li><li>Financial tracking and reporting skill.</li><li>Team player.</li><li>Passionate about process improvement.</li><li>Strong detail orientation.</li><li>Excels at continuous cost reduction/process improvement.</li><li>Excellent communication skills.</li><li>Strong stakeholder management skill.</li><li>Effective at cross-functional teamwork.</li><li>Computer literate with working knowledge of Microsoft Office including Word, Powerpoint and Excel.</li><li>Ability to navigate with ambiguity.</li><li>Ability to multi-task in a fast paced environment.</li><li>Ability to work independently and with a sense of urgency.</li><li>Comfortable with conflict.</li><li>Strong service oriented approach, with timely responsiveness.</li><li>Ability to engage and collaborate with team members and stakeholders from a distance.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</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>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Responsibilities: <ul><li>Ensuring products meet internal and external customer requirements.</li><li>Performing regular inspections and tests on raw materials, in-process components, and finished products using measurement equipment (e.g., calipers, micrometers, and gauges).</li><li>Recording inspection results and maintaining detailed quality documentation.</li><li>Identifying defects and reporting findings to supervisors or engineers.</li><li>Assisting Quality Engineers in resolving quality issues within the production operation.</li><li>Supporting root cause analysis and corrective action activities.</li><li>Complying with Health, Safety, and Environmental Policies.</li><li>Contributing to continuous improvement activities and initiatives.</li><li>Writing reports and providing data to management.&nbsp;</li></ul> Requirements: <ul><li>Experience as an Inspection or Quality Technician.</li><li>Understanding of engineering drawings and quality management systems (e.g., ISO9000, TS16949, ISO 17025).</li><li>Knowledge of statistical tools (e.g., Minitab) and data analysis.</li><li>Strong attention to detail, analytical, and problem-solving skills.</li><li>Ability to interpret technical information and work with minimal supervision.&nbsp;</li></ul>

Responsibilities: Planning and Budgeting&nbsp;<ul><li>Initiate and execute annual EHS &amp; S improvement project plan, EHS &amp; S training plan, EHS &amp; S internal audit plan and annual EHS &amp; S budget&nbsp;</li></ul> People Management &amp; Development&nbsp;&nbsp; <ul><li>Allocate and balance work across direct reports, review and provide timely performance feedback to subordinate, coach, guide, develop and motivate them,&nbsp;</li><li>help to resolve functional issues in the team, submit manpower request and interview candidates in order to achieve targeted function performance goal.&nbsp;</li><li>Develop skills of direct reports and others with EHS &amp; S responsibilities in the organization.&nbsp;</li></ul> EHS Structure &amp; Program Management&nbsp; <ul><li>Build action plans for the implementation of the organization’s EHS &amp; S programs and take a leadership role in execution in order to deliver the organization’s EHS &amp; S goals and strategy.&nbsp;</li><li>Setting up strong Safety First culture.&nbsp;</li><li>Establish and develop procedures and teams for driving EHS improvements and managing EHS programs.&nbsp;</li><li>Communicate with all levels in the organization on EHS to engage with, influence and promote EHS culture.&nbsp;&nbsp;</li><li>Follow up internal and external audit to verify EHS performance and continue improvement&nbsp;</li><li>Maintein ISO14001 and our client compliance tools.&nbsp;</li><li>Ensure safety of construction projects in the Thailand Erni site.&nbsp;</li><li>Ensure safety of plant moving, including but not limited to moving IND equipment out and DDN equipment in. As well as its installation and&nbsp;</li><li>commissioning safety&nbsp;</li></ul> Reporting&nbsp; Implement below tasks in order to meet the requirements of reporting.&nbsp; <ul><li>Report related required EHS&amp;S data to site, BU management, BU EHS and Corporate EHS.&nbsp;</li><li>Report related EHS&amp;S data required based on applicable legal regulations and company policies.&nbsp;</li><li>Monitor and report organizational safety performance against our client Safety Tool.&nbsp;</li><li>Evaluate and report environmental performance quarterly using company environmental assessment tools.&nbsp;</li></ul> Sustainability and BCP&nbsp; Focus on GHG, energy,&nbsp;hazardous waste &amp; scope 3 reduction.&nbsp;&nbsp; <ul><li>Track energy reducion data.&nbsp;</li><li>Work with Facility team to identify opportunities of energy reduction.&nbsp;</li><li>Coordinate business contunity plan of DG site.&nbsp;</li><li>Follow BU, Seg and Corp policy and lead scope 3 reduction of the site&nbsp;</li></ul> Requirements: <ul><li>University degree or equivalent level of qualification in safety, health, environmental, chemical, mechanical or related technical discipline&nbsp;</li><li>Thailand government required qualification as company EHS manager is a MUST&nbsp;</li><li>Professional EHS Certification preferred.&nbsp;</li><li>Minimum 8+ years EHS experience required.&nbsp;</li><li>Minimum 5+ years experience in EHS management in manufacturing.&nbsp;</li><li>3+ years construction safety experience is a MUST.&nbsp;</li><li>Knowledge and experenice on scope 3 is preferred.</li></ul>

Responsibilities: <ul><li>Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.</li><li>Ensure adherence to cGMP, SOPs, and regulatory standards.</li><li>Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities</li><li>Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.</li><li>Take active role in preparing the site for regulatory inspection.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits.</li><li>Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications / Experience <ul><li>Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).</li><li>5+ years of experience in pharmaceutical manufacturing, or QA.</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 21 CFR part 10, and 211.</li><li>Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, and engineering.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</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. 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>

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64 contractor safety Jobs found

Mechatronics Engineer

Logistics Supervisor

Logistics Analyst

Maintenance Engineer

Procurement Operations Manager

Production Technician I

Quality Technician

Manager - Environmental Health & Safety (EHS)

Quality Associate I

Compounding Technician

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Skills

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64 contractor safety Jobs found

Mechatronics Engineer

Logistics Supervisor

Logistics Analyst

Maintenance Engineer

Procurement Operations Manager

Production Technician I

Quality Technician

Manager - Environmental Health & Safety (EHS)

Quality Associate I

Compounding Technician

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