Warehouse Technician

Senior Product Development Engineer

Product Engineer II

Chemist Data Reviewer

Sr. Manufacturing & Process Development Engineer

Principal AWS Network Infrastructure Engineer

Staff Advanced Quality Engineer (Software)

Senior Software Engineer - Boomi or BTP

Software Engineer - Boomi or BTP

Inspection Technician

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: Performance &amp; Continuous Improvement: <ul><li>Maintain and improve existing products, processes, and specifications</li><li>Drive quality improvements and cost reduction initiatives</li><li>Support product extensions to meet specific customer requirements</li></ul> Daily &amp; Ongoing Activities: <ul><li>Manage engineering change processes (ECR/ECN)</li><li>Lead Product Change Notifications (PCN) to customers</li><li>Conduct root cause analysis and implement corrective actions</li><li>Redesign products to resolve customer complaints and manufacturing challenges</li><li>Coordinate with cross-functional teams for seamless implementation</li></ul> Periodic Responsibilities; <ul><li>Support supplier development and consolidation initiatives</li><li>Participate in A3 problem-solving, Material Review Board, and Rapid Response Board</li><li>Assist manufacturing facilities with processing issues</li><li>Collaborate with product management, sales, and customer service teams</li><li>Develop and execute product testing plans</li><li>Ensure compliance with military specifications (MIL-STD)</li></ul>&nbsp;Requirements: Education <ul><li>Bachelor’s Degree in Mechanical Engineering, Mechatronics Engineering, or equivalent</li></ul> Experience &amp; Skills <ul><li>2–3 years in product engineering or packaging engineering</li></ul> Strong expertise in: <ul><li>3D Modeling (CREO / SolidWorks / Pro-E)</li><li>GD&amp;T (Geometric Dimensioning &amp; Tolerancing)</li><li>Engineering Change Management (ECR/ECN/PCN)</li><li>Lean Manufacturing &amp; Continuous Improvement</li><li>Root Cause Analysis (A3 / 8D methodologies)</li><li>Supplier Development</li><li>Microsoft Office tools</li><li>Knowledge of military specifications (MIL-STD) is a strong advantage&nbsp;</li></ul>

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

Responsibilities: Automation &amp; Process Development <ul><li>Lead end-to-end development of automation systems, including concept design, hardware/software selection, prototyping, testing, validation, and full-scale implementation.</li><li>Conduct hands-on experimental trials to validate manufacturing processes and gather performance data.</li><li>Collaborate with Product Development teams to ensure designs align with automation and manufacturability standards.</li><li>Develop engineering specifications, preliminary designs, and support pre-production builds and testing.</li></ul> Process Optimization &amp; Problem Solving <ul><li>Apply data-driven methodologies such as Six Sigma, DMAIC, and 8D to identify root causes and improve process capability.</li><li>Analyze yield and process data to develop optimization strategies and enhance efficiency.</li><li>Research and implement new technologies and manufacturing techniques to improve quality and reduce costs.</li></ul> Project &amp; Stakeholder Management <ul><li>Manage multiple engineering projects simultaneously in a fast-paced environment.</li><li>Collaborate with vendors and cross-functional teams to support automation and process development initiatives.</li><li>Provide technical leadership and communicate complex concepts effectively to stakeholders.</li></ul> Documentation &amp; Innovation <ul><li>Prepare detailed technical documentation, design drawings, and process implementation requirements.</li><li>Support submission of invention disclosures for innovative concepts.</li><li>Contribute to the development and deployment of next-generation manufacturing technologies, including AI-driven solutions.</li></ul> Requirements: Education <ul><li>Bachelor’s degree in Electrical, Mechanical, Robotics, Mechatronics, or Electro-Mechanical Engineering (minimum).</li></ul> Experience <ul><li>5–7 years of experience in automation systems and manufacturing engineering.</li><li>Proven experience leading automation projects from concept to implementation.</li></ul> Technical Skills <ul><li>Automation systems: PLCs, HMIs, VFDs, servo motors, sensors, and actuators</li><li>PLC programming: Omron, Siemens, Allen-Bradley</li><li>Industrial robotics troubleshooting: KUKA, ABB, EPSON</li><li>Vision systems: Keyence, Cognex</li><li>CAD tools: Creo, SolidWorks, AutoCAD (2D &amp; 3D)</li><li>Strong electrical and electronic troubleshooting skills</li><li>Experience with Six Sigma / DMAIC / 8D methodologies</li><li>Exposure to Artificial Intelligence (preferred)</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>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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92 ui testing Jobs found

Warehouse Technician

Senior Product Development Engineer

Product Engineer II

Chemist Data Reviewer

Sr. Manufacturing & Process Development Engineer

Principal AWS Network Infrastructure Engineer

Staff Advanced Quality Engineer (Software)

Senior Software Engineer - Boomi or BTP

Software Engineer - Boomi or BTP

Inspection Technician

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92 ui testing Jobs found

Warehouse Technician

Senior Product Development Engineer

Product Engineer II

Chemist Data Reviewer

Sr. Manufacturing & Process Development Engineer

Principal AWS Network Infrastructure Engineer

Staff Advanced Quality Engineer (Software)

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.