Packaging Technician

Warehouse Technician

Senior Product Development Engineer

Service Manager

Principal AWS Network Infrastructure Engineer

Staff Advanced Quality Engineer (Software)

Senior Data Scientist - Machine Learning

Senior Software Engineer - Boomi or BTP

Software Engineer - Boomi or BTP

Inspection Technician

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

Role Description: <ul><li>The Warehouse Technician will be responsible for executing material handling, inventory management, and warehouse operations in support of a sterile pharmaceutical manufacturing facility producing injectable IV bag products, including high potent APIs and controlled substances.</li><li>This role will ensure materials are received, stored, issued, and shipped in compliance with cGMP, DEA, and site safety requirements.</li><li>The Warehouse Technician will play a key role in maintaining accurate inventory records, supporting production schedules, and ensuring the cleanliness, organization, and security of the warehouse.</li></ul> Responsibilities: <ul><li>Receive, inspect, and verify incoming materials, components, and supplies against purchase orders and specifications.</li><li>Ensure proper storage of raw materials, packaging components, and controlled substances in compliance with cGMP, DEA, and safety requirements.</li><li>Accurately issue and deliver materials to production areas based on production schedules and work orders.</li><li>Operate warehouse equipment such as forklifts, pallet jacks, and material handling devices in a safe and compliant manner.</li><li>Perform cycle counts, physical inventory counts, and reconciliation of discrepancies in coordination with Inventory Control.</li><li>Maintain warehouse cleanliness, organization, and environmental conditions per site procedures and regulatory requirements.</li><li>Document all material transactions in the inventory management system, ensuring data accuracy and adherence to data integrity principles.</li><li>Prepare shipments of materials, components, or finished products in compliance with applicable regulations, including hazardous material handling requirements.</li><li>Support material sampling activities, including coordination with Quality Control for testing.</li><li>Assist in warehouse procedure creation, updates, and continuous improvement initiatives.</li><li>Ensure DEA security and access control measures are followed for controlled substances.</li><li>Collaborate with Production, Quality, Planning, and Procurement to ensure timely material availability for manufacturing operations.</li></ul> Requirements: Qualifications/Experience: <ul><li>High school diploma or equivalent required; Associate’s degree preferred.</li><li>Minimum of 2 years of warehouse or material handling experience in a cGMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.</li><li>Experience handling controlled substances and/or high potent APIs preferred.</li><li>Knowledge of cGMP, DEA, and OSHA requirements for material handling and storage.</li><li>Experience operating forklifts and other warehouse equipment; forklift certification preferred.</li></ul> Skills/Competencies: <ul><li>Strong attention to detail and accuracy in documentation and inventory management.</li><li>Familiarity with inventory management systems and ERP software.</li><li>Ability to work effectively in a fast-paced, highly regulated environment.</li><li>Strong organizational skills with the ability to prioritize tasks.</li><li>Good communication and teamwork skills.</li><li>Commitment to safety, compliance, and maintaining a secure warehouse environment.</li><li>Ability to lift and move materials in accordance with safety guidelines.</li></ul>

Responsibilities: <ul><li>Manage the complete product development life cycle (starting from voice of customer, ideation, Design Conceptualization, Creation of product specifications, 3D design, Prototyping, Product testing, Product qualification, Project Execution &amp; Sustenance till product end of life)</li><li>Build a deep understanding of market and customer needs by fostering a connection between the business engineering teams and the customer engineering teams</li><li>Work closely with customer/sales/PM in getting the right and clear VOC (voice of customer), make engineering evaluation/proposal to customer.</li><li>Maintain a System level understanding of customer application and the cable design/concept necessary for providing a solution to the customers’ expectation.</li><li>Follow LEANPD Project Process to support project team from PDE perspective to complete Project (NPI or Sustaining) on time, quality and budget.&nbsp;</li><li>Drive the development and release of product, scale-up through stage-gate reviews, ensuring milestone commitments are maintained.</li><li>Technical support to customer, sales, PM and plant team.&nbsp;</li><li>Conduct necessary test, engineering analysis, trouble shooting and verification.</li><li>Work with global manufacturing resources, procurement, and outside suppliers to meet all company technical, quality, and cost objectives</li><li>Introduce breakthrough technologies by partnering technically with our customers worldwide and with our company Global competency centers to enhance business revenue &amp; growth.</li></ul> Requirements: <ul><li>Bachelor degree (Mechanical) required and Master is preferred</li><li>Knowledge about various phases of product realization and product development</li><li>Knowledge of state-of-the-art design tools such as 3D Computer Aided Design (CAD), modelling, Geometric Dimension &amp; Tolerancing (GD&amp;T), electrical &amp; electronic design and Simulation</li><li>Basic knowledge in manufacturing process (machining, molding, stamping, plating, etc.) will be a plus.</li><li>Basic knowledge in material (metal/plastic) properties will be a plus.</li><li>Knowledge of power distribution system and connection components.</li><li>Familiarity with power safety standards and agency approval of power connector/cable/cable assembly.</li><li>Basic FEA simulation on mechanical, mold-flow, and Thermal.</li><li>Familiarity with quality tools (FMEA, 6sigma, DOE, 8D…) will be a plus.</li><li>10+ years working experience as new product development related position and 5+ years of working experience on product developing of RF Products/Antennas.</li><li>Connector, especially Power/Industrial/Auto connector design background will be a plus.</li><li>Experience on power distribution inter/intra system is required.</li><li>This position is highly technical and requires an individual who can work independently.</li><li>Experience on product compliance certification (Product, Safety, Environment substance control)</li><li>Experience in design for manufacturing and assembly (DFMA), design for cost (DFC), design for manufacturing (DFM)</li><li>Application Engineering: Ability to understand customer requirements &amp; offer engineering solutions</li><li>Engineering management across cross functional teams: Developing technical roadmaps to align with market direction &amp; communicating it across business units, management &amp; customers to share applicable technology</li><li>Working together with global team.</li><li>Optimizing engineering &amp; innovation: Defining &amp; managing IP strategy &amp; constantly improving products through R&amp;D</li><li>Quick learning capability: Acquire the necessary skill set, assuring succession &amp; phase in the organization, procedure and culture.</li><li>Quality controller: Ability to assure quality for services, documents and prints.</li><li>Good presentation skills with usage of PowerPoint</li></ul>

Responsibilities: Technical: <ul><li>Collaborate with the technical support team to resolve dealer service and parts issues efficiently.</li><li>Deliver regional and on-site technical training for troubleshooting and equipment repair.</li><li>Support and advance the Service Management Development and Certification Program.</li></ul> Dealer Development: <ul><li>Participate in dealer selection and onboarding processes.</li><li>Conduct dealer capability assessments and implement performance improvement plans.</li><li>Ensure dealer compliance with technical training and certification programs.</li><li>Train dealer personnel on internal systems (Dealer Portal, service platforms, warranty systems, etc.).</li><li>Support dealerships in improving absorption rates and overall operational performance.</li></ul> Parts &amp; Service Operations: <ul><li>Partner with aftersales and dealer teams to achieve regional parts sales targets.</li><li>Monitor and manage service &amp; parts KPIs and operational metrics.</li><li>Promote the use of OEM service parts across dealerships.</li><li>Drive participation in parts programs and promotional initiatives.</li><li>Provide technical support related to parts and service operations.</li></ul> Quality, Warranty &amp; Campaigns: <ul><li>Ensure dealer adherence to warranty processes and procedures.</li><li>Monitor campaign completion and ensure 100% closure of safety-related actions.</li><li>Administer goodwill policies within budget and company guidelines.</li><li>Conduct warranty audits to ensure compliance.</li><li>Report recurring field issues to the quality team for resolution.</li></ul> Requirements: <ul><li>Minimum 5+ years of aftersales experience in agricultural, construction, or automotive industries.</li><li>Strong knowledge of dealership operations and dealer network management.</li><li>Good understanding of service and parts operations, including KPIs.</li><li>Strong technical expertise in agricultural or heavy equipment.</li><li>Excellent communication and interpersonal skills.</li><li>Ability to troubleshoot mechanical, electrical, electronic, and hydraulic systems.</li><li>Proficiency in Microsoft Office (Intermediate to Advanced).</li><li>Willingness to travel up to 75%.</li><li>Valid driver’s license with a clean driving record.&nbsp;</li></ul>

Responsibilities: Design and Implementation:&nbsp; <ul><li>Architect and deploy scalable, secure, and highly available network infrastructure solutions in AWS</li></ul> Network Management:&nbsp; <ul><li>Manage and optimize AWS networking services such as VPC, Direct Connect, Route 53, CloudWAN, and Transit Gateway</li></ul> Security:&nbsp; <ul><li>Implement and maintain network security best practices, including firewalls, VPNs, and security groups</li></ul> Automation:&nbsp; <ul><li>Develop and maintain automation scripts using tools like Terraform, CloudFormation, and Python</li></ul> Monitoring and Troubleshooting:&nbsp; <ul><li>Monitor network performance and troubleshoot issues to ensure optimal performance and reliability</li></ul> Collaboration:&nbsp; <ul><li>Work with cross-functional teams to support application development and deployment</li></ul> Documentation:&nbsp; <ul><li>Create and maintain detailed network documentation and diagrams</li></ul> Cost Management:&nbsp; <ul><li>Monitor and optimize cloud costs, implementing cost-saving measures where possible</li></ul> Compliance and Governance:&nbsp; <ul><li>Ensure that all cloud network solutions comply with our client standards</li></ul> Performance Tuning:&nbsp; <ul><li>Continuously improve the performance and reliability of network systems</li></ul> Incident Response:&nbsp; <ul><li>Lead incident response efforts for network-related issues and outages</li></ul> Training and Mentorship:&nbsp; <ul><li>Provide training and mentorship to junior network engineers and other team members</li></ul> Innovation/Continuous Learning:&nbsp; <ul><li>Stay updated with the latest cloud networking technologies and propose innovative solutions to improve the infrastructure</li></ul> Business Competencies: <ul><li class="ql-indent-1">Adaptable to work effectively within a variety of situations and with various individuals, groups or independently</li><li class="ql-indent-1">Ability to document and communicate effectively, explaining technical concepts and network initiatives in business terms in both individual and group settings</li><li class="ql-indent-1">Must be tenacious, overcoming obstacles and identifying risks</li><li class="ql-indent-1">Attention to detail will be critical to assist with the successful implementation of initiatives</li></ul> Requirements: <ul><li class="ql-indent-1">10+ years of experience in IT, with at least 5+ years in AWS cloud engineering and architecture.</li><li class="ql-indent-1">Strong understanding of AWS network infrastructure and service integration, including VPC, IAM, Transit Gateway, and CloudFormation, and how AWS services such as EC2, EKS, RDS, S3, and Lambda operate within those network architectures.</li><li class="ql-indent-1">Strong experience with Terraform, CloudFormation, and automation scripting (Bash, Python, PowerShell).</li><li class="ql-indent-1">Proficiency in monitoring and logging tools (DataDog, Splunk, Coralogix, CloudWatch).</li></ul> Technical Skills: <ul><li class="ql-indent-1">In-depth knowledge of AWS networking services and best practices, such as VPC, AWS Firewall, Transit Gateway, WAF, Security Groups, CloudWAN, NACLS, Shield Advance, and Direct Connect</li><li class="ql-indent-1">Advanced understanding of networking protocols and services such as BGP, OSPF, TCP/IP, DNS, DHCP, and VPNs</li><li class="ql-indent-1">Proficiency in network security principles and tools</li><li class="ql-indent-1">Skilled in network automation and scripting</li><li class="ql-indent-1">Experience in developing IaC with advanced skills in tools such as Terraform, AWS CloudFormation, and Ansible for automating infrastructure deployment and management</li><li class="ql-indent-1">Familiar with DevOps practices / CI/CD pipelines using tools like Jenkins, GitLab CI, or GitHub Actions to automate testing and deployment</li></ul>&nbsp;

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

Responsibilities: <ul><li>Lead the design, development, and deployment of machine learning models using Python for applications including process optimization, predictive analytics, demand forecasting, computer vision, and decision support systems</li><li>Network across manufacturing, R&amp;D, commercial, and business functions to identify and collaboratively execute on high-impact challenges solvable through machine learning techniques</li><li>Build production-ready ML solutions within enterprise platforms (Databricks, Azure ML) including model training, endpoint deployment, and monitoring</li><li>Develop and maintain scalable, modular, well-documented code following MLOps best practices including version control, logging/metadata standards, and CI/CD principles</li><li>Lead code reviews, architectural discussions, and knowledge sharing to maintain high quality, production-ready deliverables across the team</li><li>Collaborate with domain experts and stakeholders across a wide variety of domains to understand needs, integrate ML solutions into workflows, and deliver measurable business value</li><li>Communicate complex machine learning methodology, results, and business impact clearly to technical and non-technical audiences through presentations, documentation, and visualizations</li><li>Stay current with advancements in machine learning, and apply them to solve business challenges</li><li>Mentor and provide technical guidance to data scientists, helping to grow the teams capabilities in Hyderabad</li><li>Support ML governance processes including architecture and methodology reviews, risk assessments, and compliance with enterprise standards</li><li>Lead project planning and execution, managing timelines, resources, and stakeholder expectations</li></ul> Requirements: <ul><li>Masters or Ph.D. in a relevant field such as Data Science, Statistics, Mathematics, Computer Science, Operations Research, or a domain-focused field (Engineering, Chemistry, Economics, Finance, etc.)</li><li>5-8+ years of experience in data science, machine learning, or a related field with demonstrated impact</li><li>Strong foundation in statistical and machine learning theory with proven ability to select, apply, and evaluate appropriate techniques for complex, real-world problems</li><li>Extensive hands-on experience building predictive models and deploying them to production environments using Python</li><li>Proficiency with modern ML frameworks (scikit-learn, XGBoost/CatBoost, TensorFlow/PyTorch) and data manipulation libraries (pandas, polars, numpy)</li><li>Experience with solution architecting and design for ML systems</li><li>Hands-on experience with cloud platforms such as Azure and/or Databricks for deploying and managing ML models and solutions</li><li>Experience with version control (Git), collaborative development, and code review processes</li><li>&nbsp;Strong written and oral communication skills with ability to present technical concepts and results to diverse audiences from technical teams to business leadership</li><li>History of project leadership and driving initiatives from conception to production</li><li>Strong problem-solving skills and the ability to work independently as well as lead and mentor team members&nbsp;</li></ul>

Responsibilities: <ul><li>SOFTWARE DEVELOPMENT: Designs and develops high quality software solutions by writing clean, maintainable and efficient codes.</li><li>AUTOMATION: Leads the application of internal software deployment platform, methodologies and tools to automate the deployment process, ensuring smooth and reliable releases.</li><li>COLLABORATION: Partners with cross functional team of product managers, designers and different engineers to gather complex requirements and deliver solutions that meet business needs.</li><li>TESTING &amp; DEBUGGING: Writes and maintains complex unit tests and integration tests, and performs debugging to maintain the quality and performance of the software.</li><li>CONTINUOUS IMPROVEMENT: Suggests options for improving the software development and deployment processes, and implements the approved standards to improve efficiency and reliability.</li><li>DOCUMENTATION: Builds and maintains comprehensive documentation for complex software applications, deployment processes and system configurations.</li><li>TECHNICAL SUPPORT: Provides technical support and troubleshooting for complex issues with deployed applications to ensure minimal downtime and fast resolution.</li></ul> Requirements: <ul><li>Minimum requirement of 4 years of relevant work experience.</li><li>Typically reflects 5 years or more of relevant experience.</li><li>SAP BTP and/or Boomi expertise</li><li>7+ years of professional experience</li></ul>

Responsibilities; Software Develpoment:&nbsp; <ul><li>Designs and develops high quality software solutions by writing clean, maintainable and efficient codes.&nbsp;</li></ul> Automation:&nbsp; <ul><li>Leads the application of internal software deployment platform, methodologies and tools to automate the deployment process, ensuring smooth and reliable releases.&nbsp;</li></ul> Collabroation:&nbsp; <ul><li>Partners with cross functional team of product managers, designers and different engineers to gather complex requirements and deliver solutions that meet business needs.&nbsp;</li></ul> Testing &amp; Debugging:&nbsp; <ul><li>Writes and maintains complex unit tests and integration tests, and performs debugging to maintain the quality and performance of the software.&nbsp;</li></ul> Continoud Improvement:&nbsp; <ul><li>Suggests options for improving the software development and deployment processes, and implements the approved standards to improve efficiency and reliability.&nbsp;</li></ul> Documentation:&nbsp; <ul><li>Builds and maintains comprehensive documentation for complex software applications, deployment processes and system configurations.&nbsp;</li></ul> Technical Support:&nbsp; <ul><li>Provides technical support and troubleshooting for complex issues with deployed applications to ensure minimal downtime and fast resolution.&nbsp;</li></ul> Requirements: <ul><li>Minimum requirement of 2 years of relevant work experience. Typically reflects 3 years or more of relevant experience.&nbsp;</li></ul> Preferred Qualifications: <ul><li>SAP BTP and/or Boomi expertise</li><li>4+ years of professional experience</li></ul>

Role Description: <ul><li>Purpose Statement The Inspection Technician is responsible for sterile pharmaceutical inspection operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.</li><li>This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures.</li><li>The Inspection Technician serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.</li><li>This position will include cross training for support of formulation, IV Bag filling, leak inspection, dispensing and packaging.</li></ul> Responsibilities: <ul><li>Operate, monitor, and adjust IV Bag inspection equipment and direct 100% inspection of filled IV-bags of various sizes and configuration.</li><li>Secondary responsibilities will include operating manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform visual inspection of final product to ensure conformance with quality standards and specifications.</li><li>Perform AQL testing manually to verify integrity of the automated inspection system.</li><li>Serve as first-line troubleshooting support for equipment and GMP manufacturing issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to other production personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications/Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of product post fill inspection.</li><li>Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with skills including the ability to concisely describe problems to mechanics.</li><li>Knowledge of cGMP, and aseptic processing, requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI required. Experience with a supervisory controller and data acquisition system (SCADA) interface will be a plus.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Precise skills for inspecting finished product effectively.</li><li>Demonstrated problem-solving and troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>Comfortable working in cleanroom environments with PPE requirements.</li></ul>

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121 application security assessments Jobs found

Packaging Technician

Warehouse Technician

Senior Product Development Engineer

Service Manager

Principal AWS Network Infrastructure Engineer

Staff Advanced Quality Engineer (Software)

Senior Data Scientist - Machine Learning

Senior Software Engineer - Boomi or BTP

Software Engineer - Boomi or BTP

Inspection Technician

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Skills

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121 application security assessments Jobs found

Packaging Technician

Warehouse Technician

Senior Product Development Engineer

Service Manager

Principal AWS Network Infrastructure Engineer

Staff Advanced Quality Engineer (Software)

Senior Data Scientist - Machine Learning

Senior Software Engineer - Boomi or BTP

Software Engineer - Boomi or BTP

Inspection Technician

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