Associate Data Engineer

Continuous Improvement Analyst III

Senior Manufacturing Engineer

Compounding Technician

Filling Technician

Senior - Data Engineer

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Senior Quality & Reliability Engineer

Senior Project Management Engineer

Responsibilities: <ul><li>Ability to troubleshoot problems in a live environment and provide real time help with critical issues.</li><li>Write code that is easily understood and maintainable by other team members.</li><li>Keep up to date with developments in technologies we are using.</li><li>Ability to communicate and work effectively, supporting various business departments.</li><li>Ability to work in fast-paced interdisciplinary environment.</li></ul> Requirements <ul><li>BA/BS in Computer Science or equivalent practical experience.&nbsp;</li><li>At least 3+ years of post-university experience as a full-stack engineer.</li><li>Solid knowledge of programming fundamentals—algorithms, data structures, design patterns, and paradigms.</li><li>Strong knowledge of Python.</li><li>Solid knowledge SQL and relational databases.</li><li>Knowledge of Extract-Transform-Load (ETL) and big data analytics tools.</li><li>Experience working in a cloud environment (AWS, Azure, GCP).</li><li>Familiarity with popular Python data analytics frameworks.</li><li>Familiarity with Snowflake or other large analytics engines.</li><li>Experience with data warehousing and working in environments with large scale, complex analytics requirements.</li><li>Familiarity with DAG-based job scheduling tools.</li><li>Cloud-native container orchestration platforms and tools.</li><li>Experience working in the Financial Services industry.</li></ul>

Responsibilities: <ul><li>Facilitate, lead, or coach Kaizen and Kaizen events across the organization.</li><li>Work collaboratively with tool or element owners to implement Continuous Improvement tools.</li><li>Lead and audit Continuous Improvement tools.</li><li>Train teams in Continuous Improvement methodologies, tools, and transformation methods (e.g., 5S, TPM, Value Stream Mapping, VSM-D, CCF, 3P, Lean Manufacturing).</li><li>Facilitate and train teams for transformation Kaizen events in highly impactful areas or production cells.</li><li>Obtain internal certifications such as Novice, Apprentice, and Practitioner level in Continuous Improvement.</li><li>Provide coaching to Novice and Apprentice practitioners.</li><li>Train and coach teams on plant Key Performance Indicators (KPIs).</li><li>Report periodic progress on assigned tools, metrics, and initiatives.</li><li>Conduct capacity analysis and mentor production supervisors on managing line capacity.</li><li>Develop scenarios for capacity planning, including footprint analysis.</li><li>Apply advanced knowledge in line balancing and its implications for realistic planning (cross-training, validations, capacity planning, hiring requirements, etc.).</li></ul> Requirements: Knowledge &amp; Experience <ul><li>Bachelor’s Degree in Industrial Engineering or related field.</li><li>3–5 years of experience in continuous improvement, cost savings, or productivity improvement roles.</li><li>Lean certification required.</li><li>Green Belt or Black Belt certification is desirable.</li><li>Experience in process improvement, Six Sigma, and product/process qualification and validation.</li><li>Bilingual (English/Spanish).</li></ul> Skills <ul><li>Proficiency in Microsoft Office 365.</li><li>Strong skills in Excel (Pivot Tables, Charts, Macros), PowerPoint, MS Project, AutoCAD (or similar), Minitab, and simulation software.</li><li>Knowledge of problem-solving techniques.</li><li>Basic competency in creating dashboards using Power BI.</li><li>Basic knowledge of Power Automate or similar tools.</li><li>Ability to work under pressure with strong communication and teamwork skills.</li><li>Experience influencing all organizational levels to support an Operational Excellence culture.</li></ul>

Responsibilities: <ul><li>Lead a dedicated team of engineers and technicians within the Projects or Manufacturing group.</li><li>Ensure that engineers are fully integrated into the overall project team and production support activities.</li><li>Plan and implement training and development programs for direct reports.</li><li>Complete process design and development projects by training and guiding technicians.</li><li>Provide coaching and mentorship to team members.</li><li>Establish engineering goals and objectives aligned with business plans.</li><li>Identify and implement effective, permanent technical and system solutions to problems.</li><li>Consistently meet customer requirements, performance expectations, and deadlines.</li><li>Prepare product and process reports by collecting, analyzing, and summarizing information and trends.</li><li>Champion compliance with internal systems and processes.</li><li>Identify and develop improvements to enhance Service, Delivery, Quality, and Cost metrics using Lean/Six Sigma methodologies.</li><li>Research advanced process technologies and evaluate potential competitive advantages and cost benefits.</li><li>Lead or guide a portfolio of engineering projects in collaboration with cross-functional teams (e.g., NPI, quality engineering, design assurance, R&amp;D).</li><li>Collaborate with teams to plan, coordinate, and implement activities supporting the successful launch of new products, including make/buy analysis, new process introduction, and more.</li><li>Develop or modify manufacturing processes by studying product requirements and designing, modifying, or testing manufacturing methods and equipment.</li><li>Maintain professional and technical knowledge through workshops, publications, networking, and participation in professional societies.</li><li>Manage external relationships with key technology suppliers.</li><li>Oversee workload distribution among engineers and technicians to meet operational and business priorities.</li></ul>&nbsp;Requirements: Education &amp; Experience <ul><li>Bachelor’s degree or equivalent in an Engineering field with 5–10 years of experience in a demanding high-volume production environment or a high-mix, low-volume environment.</li><li>Experience in medical devices or similar regulated manufacturing and quality systems is essential.</li><li>Proficiency with CAD tools; SolidWorks preferred.</li><li>Experience using Minitab, MS Project, and advanced Excel.</li><li>Demonstrated ability to lead a production-focused team, drive technical problem solving, and manage line setup including equipment acquisition and process development.</li><li>Working knowledge of Lean and/or Six Sigma engineering principles with proven results.</li><li>Statistical knowledge, including data analysis and statistical software (JMP, Minitab, etc.).</li><li>Lean Six Sigma Green Belt certification preferred.</li><li>Excellent communication, planning, and organizational skills.</li><li>Self-motivated with strong decision-making abilities.</li><li>Willingness to work independently and to take on an international assignment of up to 3 months.</li><li>Fluent in English (written and verbal), &gt;80% proficiency.</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>

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

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

Overview: <ul><li>The Equipment Engr - Automation and PLC is responsible for ensuring the reliable performance of production equipment by developing, modifying, and troubleshooting PLC programs and CCD (vision) systems.&nbsp;</li><li>The role supports day-to-day plant operations through automation debugging, sequencing improvements, and real-time issue resolution to enhance productivity and OEE.&nbsp;</li><li>This position leads technical training for technicians and new team members, documents system updates, and contributes to continuous improvement initiatives, including deployment and ISO compliance.&nbsp;</li><li>The engineer serves as a key resource in maintaining stable, efficient, and high-quality automated manufacturing processes.</li></ul> Responsibilities: <ul><li>Trouble shooting, Modify or Create Machine PLC program to suit the need of the plant.</li><li>Responsibel for repair and maintenance of the CCD System of the production line.</li><li>PLC system of the automation debugging and improve the sequencing.</li><li>Suggest improvement of automation PLC program to improve productivity and OEE.</li><li>Train technician to resolve the issues encountered between the production.</li><li>CCD light adjustments to improve the performance.</li><li>Responsible to resolve all issues encounter during production run.&nbsp;</li><li>Support on resolving CCD issues encounter during production run and documenting.&nbsp;&nbsp;</li><li>Impart trainings and development for new joiners, Technical Trainees etc.</li><li>Review of deployment</li><li>Review ISO documents and update, Engage in ISO audits.</li></ul> Requirements:&nbsp; <ul><li>Bachelor in Major in Electrical/Electronics</li><li>Preferably Mechanical, Electrical/Electronics and Industrial Engineer,</li><li>5 years minimum experience in the automation assembly and Tooling Design &amp; Development</li></ul> Knowledgeable on this different type of Programming Languages: <ul><li>Ladder Logic</li><li>Function block diagrams</li><li>Structured text</li><li>Sequential flow charts</li><li>Instruction List</li></ul>

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

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

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111 validation engineer Jobs found

Associate Data Engineer

Continuous Improvement Analyst III

Senior Manufacturing Engineer

Compounding Technician

Filling Technician

Senior - Data Engineer

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Senior Quality & Reliability Engineer

Senior Project Management Engineer

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Skills

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111 validation engineer Jobs found

Associate Data Engineer

Continuous Improvement Analyst III

Senior Manufacturing Engineer

Compounding Technician

Filling Technician

Senior - Data Engineer

Equipment Engr - Automation and PLC

Manufacturing Engineer II - CCD Support

Senior Quality & Reliability Engineer

Senior Project Management Engineer

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

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