VAVE Staff Product Development Engineer

Senior Quality & Reliability Engineer

Strategic Sourcing Analyst

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supply Chain Analyst lll

Senior Site Quality Manager

Supply Chain Analyst III

Engineering Supervisor

Process Equipment Engineer

Responsibilities: <ul><li>Lead VAVE initiatives to optimize cost, improve product performance, and enhance customer value while maintaining quality and reliability.</li><li>Go beyond traditional VAVE by driving R&amp;D in emerging materials, advanced manufacturing processes, automation, digital technologies, and innovative supplier solutions.</li><li>Collaborate with cross-functional teams, suppliers, and technology centers to identify, assess, and implement value-driven design and process improvements.</li><li>Develop and deploy tools and methods to analyze cost, performance, manufacturability, and sustainability throughout the product lifecycle.</li><li>Build and maintain a pipeline of VAVE projects in partnership with engineering, procurement, operations, and product management.</li><li>Serve as a subject matter expert in cost optimization and value engineering strategies, including advanced sourcing and alternative design concepts.</li><li>Partner with customers, sales, and product managers to gather Voice of Customer (VOC) insights and translate them into engineering solutions.</li><li>Provide technical support for cost-reduction activities, including design validation, troubleshooting, and verification of VAVE solutions.</li><li>Collaborate globally with manufacturing, procurement, and suppliers to ensure compliance with technical, quality, cost, and delivery objectives.</li><li>Introduce breakthrough engineering solutions that leverage new technologies and supplier capabilities to accelerate business growth.</li><li>Application Engineering: Understanding customer requirements and offering sustainable cost-efficient design solutions.</li><li>Engineering Management: Developing technical roadmaps aligned with market trends and effectively communicating them to business units, management, and customers.</li><li>Collaboration: Working efficiently with global teams and cross-functional stakeholders.</li><li>Technical Expertise: Adapting to new skills, futuristic materials, advanced manufacturing processes, automation, digital technologies, and innovative supplier solutions.</li><li>Quality Control: Ensuring accuracy and quality in services, documentation, and engineering outputs.</li></ul> Requirements: <ul><li>Master’s degree in mechanical engineering from premier institution.</li><li>Deep understanding of product, design, materials (metals/plastics properties), processes and manufacturing science/technology.</li><li>Knowledge of manufacturing processes such as machining, molding, stamping, and plating is advantageous.</li><li>Familiarity with material standards and agency approvals for connectors, cables, and cable assemblies.</li><li>Experience in environmental life cycle assessment, circular economy, or product stewardship/compliance.</li><li>Knowledge of ISO/IEC/UL standards related to carbon footprint and emissions reduction in industrial products.&nbsp;</li><li>Minimum of 12 years of experience in Product Development, R&amp;D and VAVE engineering.</li><li>Background in connector design (Power/Industrial/Auto connectors) is a plus.</li><li>Ability to work independently in a highly technical environment.</li><li>Expertise in Design for Cost (DFC), Design for Manufacturing (DFM), and Design for Sustainability (DFS).</li><li>Strong Presentation Skills: Proficiency in PowerPoint and effective communication of technical concepts.</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>

Responsibilities: Supplier Management &amp; Development: <ul><li>Identify, evaluate, and onboard new suppliers to support business requirements.</li><li>Conduct supplier audits and performance assessments to ensure quality and reliability.</li><li>Develop and maintain strong supplier relationships to improve lead times, cost, and supply chain efficiency.&nbsp;</li></ul> Cost Management &amp; Negotiation: <ul><li>Analyze cost structures and negotiate favorable terms for materials and components.</li><li>Support cost-reduction initiatives through competitive bidding, alternative sourcing, and value engineering.</li><li>Collaborate with finance and procurement teams to optimize the sourcing budget.</li></ul> Technical &amp; Cross-Functional Collaboration: <ul><li>Work closely with engineering, R&amp;D, and manufacturing teams to define sourcing requirements.</li><li>Ensure suppliers meet technical specifications and quality standards.</li><li>Support new product development by identifying suitable suppliers for prototypes and production.&nbsp;</li></ul> Supply Chain Optimization &amp; Risk Mitigation: <ul><li>Monitor market trends and risks to ensure a stable and competitive supply chain.</li><li>Develop strategies to mitigate supplier risks related to quality, pricing, and geopolitical factors.</li><li>Optimize sourcing strategies to reduce lead times and ensure on-time delivery.</li></ul> Requirements: Required Qualifications &amp; Skills: Education &amp; Experience: <ul><li>Bachelor’s degree in mechanical engineering, Electrical Engineering, Supply Chain Management, or a related field.</li><li>5+ years of experience in sourcing, procurement, or supplier management (preferably in automotive, electronics, or manufacturing industries).</li></ul> Technical &amp; Soft Skills: <ul><li>Strong negotiation and analytical skills.</li><li>Experience in working with SAP systems and sourcing tools.</li><li>Knowledge of supplier qualification processes, cost analysis, and risk assessment.</li><li>Familiarity with engineering drawings, specifications, and manufacturing processes.</li><li>Excellent communication, stakeholder management, and problem-solving abilities.</li></ul>

Responsibilities: <ul><li>Support bulk cable team by tracking quality, compiling reports, assist with DOEs and product qualification</li><li>Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Implement quality planning and controls for prototype and/or sample builds.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Coordinate sample preparation and certification for product verification and qualification testing.</li><li>Conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR).</li><li>Collaborate with MPDE, monitor process capability/data and oversee ongoing corrective actions as required.</li><li>Collaborate with corporate UL team / UL engineer/PJE/PQE for new certification. -Collaborate with PDE, analyze physical/SI data and make qualification report.</li><li>Collaborate with PDE, CA PDE/SI/MPDE, support SQE on outsourced cable quality control and improvement from bulk cable engineering side.</li><li>Preparation for prototype/sample making: -Organize and facilitate Design Review (DR) and Design Failure Modes &amp; Effects Analysis (DFMEA) reviews.</li><li>Complete measurement system analysis for inspection systems and gages to be utilized for the project.</li><li>Data Analysis:Monitor process physical/SI data.</li><li>Review and analyze samples, quality issues and improvement actions during prototype making and CTAR/Qualification.</li><li>Review 108 and finish 501 documents per customer requirement and industrial standards.</li><li>Coordinator during prototype/sample making: -Monitor process capability and oversee ongoing corrective actions as required.</li><li>Support MPDE on FACA.</li><li>Support PDE on design improvement.</li><li>Coordinator during outsourced cable qualification process:Review outsourced cable Physical data, SI data, Reliability data, stability data, give comments from bulk cable engineering side on supplier quality and product quality.</li></ul> Requirements:﻿ <ul><li>Bachelors or Masters Degree in science or technology.</li><li>10 years min. working experience in bulk cable design or manufacturing.</li><li>3 years team management experience.</li><li>Familiar with bulk cable knowledge, bulk cable manufacturing knowledge and machines knowledge.</li><li>Can work under the pressure.</li><li>Drive for results, good problem solving skills</li><li>Good communication skill, integrity, accountability and passion, Integrity, ccountability, team work</li><li>Good communication, interpersonal and management skills</li></ul>

Responsibilities: <ul><li>Collaborate with engineering, production, and planning teams to continuously improve product quality across the manufacturing process.</li><li>Supervise and manage the incoming and final inspection areas.</li><li>Drive improvement initiatives within incoming, in-process, and final inspection operations.</li><li>Prioritize inspection activities to ensure timely completion of production materials, engineering validations, and gage R&amp;Rs.</li><li>Identify and execute containment actions for nonconforming materials found during in-process or final inspections.</li><li>Work with cross-functional teams to investigate nonconforming products using root cause analysis tools (Ishikawa, 5-Whys, Is-Is Not, etc.) and implement corrective and preventive actions.</li><li>Communicate with customers regarding product-related complaints and facilitate evaluation and return of materials as needed.</li><li>Investigate product quality issues related to customer returns (e.g., nonconforming material reports, corrective actions).</li><li>Create and update operations procedures and documentation used within production.</li><li>Ensure compliance with quality assurance policies and procedures to meet or exceed customer expectations.</li><li>Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance product quality.</li><li>Conduct manufacturing and quality system audits to ensure compliance with ISO 13485.</li><li>Support operational projects such as Kaizen, data analysis, and problem-solving initiatives.</li></ul> Requirements: Qualifications/Background: <ul><li>Bachelor’s degree in Quality, Science, or Engineering preferred (High School Diploma with equivalent experience will be considered).</li><li>Prior experience as a Quality Engineer in a manufacturing environment.</li><li>5+ years of industry experience in a medical device manufacturing or pharmaceutical environment.</li><li>Supervisory or management experience preferred.</li><li>Working knowledge of FDA, ISO, and MDD quality systems applicable to medical device companies.</li><li>Excellent written and verbal communication skills.</li></ul>

Responsibilities: <ul><li>Develop and implement an end-to-end Stocking Policy framework for both raw materials and finished goods for Malaysia and Philippines plants</li><li>Collaborate with cross-functional team and ensure alignment on the stocking policy</li><li>Align inventory strategies with modes of shipment to balance the cost, lead time, and service reliability</li><li>Adjust safety stock parameters based on shipment mode-specific lead times and transit variability</li><li>Work closely with the logistics team to ensure mode of shipment decisions support stocking and replenishment strategies</li><li>Recommend shipment mode adjustments in response to supply chain disruptions, capacity constraints, or changes in demand patterns</li><li>Conduct simulation analysis to provide the impact of changes to stocking policy and mode of shipment on leadtime, inventory, warehousing, and transportation cost</li><li>Ensure governance processes are in place to maintain data accuracy and consistency of stocking policy across Malaysia and Philippines plants and stakeholders</li><li>Drive continuous improvement initiatives to enhance stocking efficiency, optimize inventory, and cost, and enhance customer satisfaction</li><li>Support capability building by training supply chain teams on stocking policy concepts, tools, and governance processes</li><li>Follow up on block inventory and push owners to solve issues</li><li>Follow RMA closely on time</li></ul>&nbsp;Requirements: ·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Bachelor’s degree in supply chain, Operations Management, Industrial Engineering, or related field·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Minimum 10 years of experience in Supply Chain management.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5+ years working experience in Supply Chain roles – Materials Planning, Factory Planning, Finished Goods Planning·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experience using SAP S/4 Hana, IBP, or equivalent planning tools is a must·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Strong analytical continuous improvement skills as well as a good understanding of data analytics capabilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Proven end-to-end Supply Chain experience, with a strong focus on strategic aspects rather than purely tactical or operational functions.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Expertise in stocking policies, logistics, and related processes.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Demonstrated involvement in Continuous Improvement initiatives and projects.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Strong cross-functional collaboration experience.Proven capability in implementing new processes and systems

Responsibilities: <ul><li>Lead and develop the quality team, fostering a culture of continuous improvement and cross-department collaboration.</li><li>Partner with manufacturing, engineering, and global quality teams to ensure product quality, process capability, and regulatory compliance.</li><li>Champion and uphold plant-wide quality standards, policies, and systems in alignment with corporate and customer requirements.</li><li>Monitor and report key quality performance indicators (e.g., customer complaints, internal defects) and provide actionable insights to plant leadership.</li><li>Manage internal and external audits and ensure audit readiness across the facility.</li><li>Oversee plant-wide quality improvement initiatives to reduce defects and scrap and improve process control and product reliability.</li><li>Lead root cause analysis, corrective actions, and continuous improvement efforts to address recurring quality issues.</li><li>Collaborate with engineering and production teams to ensure new product introduction (NPI) meets quality standards.</li><li>Mentor and coach quality team members to foster a high-performance culture.</li><li>Travel as required to support internal and external customer needs and NPI programs.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering, Quality, or a related technical field (preferred).</li><li>8+ years of progressive quality experience in a manufacturing environment.</li><li>Strong knowledge of ISO 9001 and regulatory compliance standards.</li><li>Minimum of 3 years in a leadership role managing quality teams.</li><li>Expertise in Lean Manufacturing and advanced quality methodologies.</li><li>Proven experience with 8D problem solving, FMEA, DOE, SPC, and safe launch processes.</li><li>Proficiency in quality data analysis tools such as Minitab, JMP, or similar.</li><li>Excellent communication, analytical, and leadership skills, with the ability to inspire and motivate teams.</li></ul>

JOB SUMMARYOur client’s business unit is seeking a motivated, highly analytical, and detail- oriented Supply Chain Analyst to join our Central Planning team. This role will manage, optimize, and develop capabilities in key areas of our supply chain, including End-to-End Stocking Policy, Safety Stocks, and Mode of Shipment for both raw materials and finished goods. The ideal candidate will leverage data and analytics to ensure efficient operations, seamless collaboration, and drive supply chain excellence. Key Responsibilities:<ul><li>Develop and implement an end-to-end Stocking Policy framework for both raw materials and finished goods for Malaysia and Philippines plants</li><li>Collaborate with cross-functional team and ensure alignment on the stocking policy</li><li>Align inventory strategies with modes of shipment to balance the cost, lead time, and service reliability</li><li>Adjust safety stock parameters based on shipment mode-specific lead times and transit variability</li><li>Work closely with the logistics team to ensure mode of shipment decisions support stocking and replenishment strategies</li><li>Recommend shipment mode adjustments in response to supply chain disruptions, capacity constraints, or changes in demand patterns</li><li>Conduct simulation analysis to provide the impact of changes to stocking policy and mode of shipment on leadtime, inventory, warehousing, and transportation cost</li><li>Ensure governance processes are in place to maintain data accuracy and consistency of stocking policy across Malaysia and Philippines plants and stakeholders</li><li>Drive continuous improvement initiatives to enhance stocking efficiency, optimize inventory, and cost, and enhance customer satisfaction</li><li>Support capability building by training supply chain teams on stocking policy concepts, tools, and governance processes</li><li>Follow up on block inventory and push owners to solve issues</li><li>Follow RMA closely on time</li></ul>&nbsp;&nbsp;<img src="//:0" height="6" width="696">Qualifications:&nbsp;What should your background look like:·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Bachelor’s degree in supply chain, Operations Management, Industrial Engineering, or related field·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Minimum 10 years of experience in Supply Chain management.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5+ years working experience in Supply Chain roles – Materials Planning, Factory Planning, Finished Goods Planning·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experience using SAP S/4 Hana, IBP, or equivalent planning tools is a must·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Strong analytical continuous improvement skills as well as a good understanding of data analytics capabilities·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Proven end-to-end Supply Chain experience, with a strong focus on strategic aspects rather than purely tactical or operational functions.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Expertise in stocking policies, logistics, and related processes.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Demonstrated involvement in Continuous Improvement initiatives and projects.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Strong cross-functional collaboration experience.<ul><li>·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Proven capability in implementing new processes and systems.</li></ul>

Role Description: <ul><li>The Engineering Supervisor leads a team of skilled mechanics and technicians responsible for the maintenance, troubleshooting, and reliability of facility infrastructure, clean utilities, laboratory systems, and pharmaceutical production equipment at our new sterile injectable manufacturing site.</li><li>This individual will play a key leadership role in coaching, mentoring, and developing technical staff, while ensuring all maintenance activities are performed safely, efficiently, and in compliance with cGMP and regulatory requirements.</li><li>This is a pivotal role in a startup manufacturing environment, requiring strong leadership, technical depth, and a commitment to operational excellence and safety.</li></ul> Responsibilities: <ul><li>Supervise and develop a team of mechanics and technicians supporting facilities, utilities, lab and production equipment. Additional oversight of contractors will be expected.</li><li>Coach, train, and mentor team to build technical depth and promote a culture of ownership and continuous improvement.</li><li>Lead daily planning, prioritization, and execution of maintenance and reliability activities.</li><li>Conduct performance reviews, skill assessments, and development planning for direct reports.</li><li>Lead the maintenance, calibration, and repair of critical systems including HVAC, compressed air, WFI, clean steam, Nitrogen generation, isolators, fillers, automated inspection and leak detection equipment, automated secondary packaging equipment, lab systems, stability chambers, site infrastructure, and the Building Management System (BMS).</li><li>Ensure all activities are conducted in compliance with cGMP, safety regulations, maintenance plans and SOPs.</li><li>Support commissioning, qualification (IQ/OQ/PQ), and startup activities for new systems and equipment.</li><li>Drive proactive and preventive maintenance through CMMS system utilization and performance tracking.</li><li>Ensure good documentation practices and data integrity so all maintenance records are accurate, complete, and auditable.</li><li>Enforce a culture of safety focusing on EHS compliance, including Lockout/Tagout, confined space entry, Arc flash protection, and chemical safety protocols.</li><li>Support audits and inspections by regulatory agencies and internal quality teams.</li><li>Analyze equipment performance and maintenance data to identify trends, root causes, and opportunities to reduce downtime and increase reliability.</li><li>Collaborate with engineers, production, and quality teams to improve reliability and maintainability of equipment.</li><li>Manage spare parts strategy and implement inventory management process.</li></ul> Requirements: Qualifications/Experience: <ul><li>Associate or bachelor’s degree in engineering, Facilities Management, Industrial Technology, or related field (or equivalent experience).</li><li>Minimum 5+ years of experience in pharmaceutical, biotech, or regulated manufacturing environment, with 2+ years in a supervisory or team lead role.</li><li>Strong technical knowledge of clean utilities, facility systems, secondary packaging and aseptic manufacturing equipment.</li><li>Experience supervising or mentoring maintenance personnel.</li><li>Experience in controlled substance and high potent product environment desired.</li></ul> Skills/Competencies: <ul><li>Working knowledge of cGMPs, regulatory expectations, and CMMS systems (e.g., Blue Mountain, SAP PM, Maximo, etc.)</li><li>Strong organizational, communication, and leadership skills.</li><li>Demonstrated commitment to safety, compliance, and team development.</li><li>Excellent interpersonal, communication, and problem-solving skills.</li><li>Comfortable working in a fast-paced, evolving environment where agility and adaptability are key.</li><li>Strong leadership presence with demonstrated ability to build high-performing teams and compliance culture.</li><li>Effective communication, collaboration, and influencing skills across multiple stakeholders.</li></ul>

Role Description: <ul><li>The Process Equipment Engineer will be a key technical leader responsible for the design, specification, procurement, installation, qualification, and ongoing reliability of process equipment for a greenfield sterile injectable IV bag manufacturing facility.</li><li>This role will play a critical part in ensuring that all manufacturing equipment all sterile manufacturing equipment are compliant with cGMP requirements, supports aseptic processing standards, and are capable of delivering high-quality product performance from day one of commercial operations. </li><li>Equipment includes sterile isolators, compounding, automated inspection, and secondary packaging for the production of sterile IV bags.</li><li>Working cross-functionally during the startup phase, the incumbent will drive equipment readiness, validation support, and serve as a technical subject matter expert (SME) for process equipment throughout the facility lifecycle.</li></ul> Responsibilities: <ul><li>Lead the specification, selection, and procurement of sterile injectable manufacturing process equipment, including isolator filling lines, formulation vessels, mixing systems inspection equipment, secondary packaging equipment, and associated support systems.</li><li>Develop user requirement specifications (URS), functional specifications (FS), and detailed equipment design documentation in compliance with regulatory and operational standards.</li><li>Manage equipment vendors, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), and oversee equipment delivery, installation, and commissioning.</li><li>Promote and ensure adherence to safety protocols and safe work practices.</li><li>Perform risk assessments for engineering and maintenance activities.</li><li>Collaborate with Validation, Quality, and Operations teams to support equipment qualification (IQ/OQ/PQ) and ensure all systems meet regulatory expectations for sterile manufacturing.</li><li>Establish preventative maintenance programs, spare parts inventories, and equipment lifecycle management plans to ensure long-term equipment reliability and availability.</li><li>Provide technical expertise during troubleshooting, deviations, and investigations related to process equipment performance, ensuring rapid resolution of issues.</li><li>Partner with Manufacturing and Quality teams to optimize equipment performance, drive continuous improvement initiatives, and support ongoing process optimization.</li><li>Identify and implement process improvements to enhance operational safety, efficiency, and reliability.</li><li>Support development of SOPs, equipment manuals, and operator training programs to ensure safe and compliant operation of process equipment.</li><li>Ensure equipment designs fully comply with cGMP, FDA, OSHA, and all applicable regulatory and safety standards.</li><li>Contribute to capital project planning, budgeting, and project execution related to new equipment or facility expansions.</li><li>Ensure ongoing regulatory inspection readiness and serve as SME for process systems during audits and inspections.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical engineering, Chemical Engineering, Industrial Engineering, or related field.</li><li>3+ years of experience in pharmaceutical process equipment engineering, with significant exposure to sterile injectable manufacturing strongly preferred.</li><li>Direct experience with design, procurement, and qualification of aseptic manufacturing equipment and cleanroom environments.</li><li>Solid understanding of cGMP regulations, FDA/EMA expectations, and engineering best practices for sterile operations.</li><li>Experience working in greenfield or major facility expansion projects highly desirable.</li></ul> Skills/Competencies: <ul><li>Strong technical knowledge of process equipment design, aseptic manufacturing, and utility systems.</li><li>Proven project management skills with ability to handle complex, cross-functional projects.</li><li>Excellent problem-solving abilities and root cause investigation experience.</li><li>Effective communication and vendor management skills.</li><li>Ability to work independently in a fast-paced, startup-like environment.</li><li>Strong teamwork, collaboration, and continuous improvement mindset.</li><li>High attention to detail with strong commitment to safety, compliance, and product quality.</li></ul>

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18 reliability Jobs found

VAVE Staff Product Development Engineer

Senior Quality & Reliability Engineer

Strategic Sourcing Analyst

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supply Chain Analyst lll

Senior Site Quality Manager

Supply Chain Analyst III

Engineering Supervisor

Process Equipment Engineer

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18 reliability Jobs found

VAVE Staff Product Development Engineer

Senior Quality & Reliability Engineer

Strategic Sourcing Analyst

Staff Quality & Reliability Engineer

Supervisor – Quality & Reliability Engineering

Supply Chain Analyst lll

Senior Site Quality Manager

Supply Chain Analyst III

Engineering Supervisor

Process Equipment Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.