• Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase. • Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs supporting drug substance and drug product development. • Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies aligned with regulatory expectations. • Review and approve validation protocols, raw data, and reports (for test method, process, cleaning, etc.). • Manage the batch release program by reviewing executed documentation, raw data, quality events (change controls, deviations, CAPAs, OOS/OOT investigations, risk assessments) and product disposition decisions. • Review and approve master and executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and ongoing evaluation ensuring batches are compliant with cGMP requirements. • Lead or support quality event resolution investigations (e.g., OOS/OOT results, deviations), ensuring root cause analysis, CAPA development, and timely closure. • Support inspection readiness, audit programs, risk management, quality metrics reporting, Annual Product Review (APR) and product quality processes, Field Alert Report (FAR), product withdrawal, and product recall process. • Perform data integrity and compliance assessments including review against source documentation for regulatory submissions. • Maintain effective communication with Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Laboratories (CTLs) to ensure Quality objectives are achieved in accordance with project timelines. • Maintain awareness of evolving veterinary pharmaceutical regulations and ensure compliance strategies are updated accordingly.

Role Description We are seeking a highly skilled and experienced Senior Systems Engineer to support IBM i, AIX, storage, backup, and high availability environments. This role is responsible for maintaining, monitoring, and supporting IBM Power Systems and related infrastructure while serving as a technical liaison between IT Infrastructure, Service Delivery, and Sales teams. The ideal candidate will provide expert guidance on implementation strategy, solution supportability, operational readiness, and long-term infrastructure reliability. Key Responsibilities - Maintain, monitor, and support IBM Power Systems, IBM i, AIX, storage, backup, and related data center infrastructure. - Serve as a technical liaison between IT Infrastructure, Service Delivery, and Sales teams to evaluate upcoming implementations and confirm ongoing solution supportability. - Monitor infrastructure security, identify risks or gaps, and provide recommendations to improve security posture and operational resilience. - Install, configure, and manage IBM Power Systems high availability solutions, including PowerHA, MIMIX, host-based replication products, and SAN replication technologies. - Provide after-hours support for infrastructure emergencies, scheduled maintenance, upgrades, and critical incident response. - Develop and maintain accurate technical documentation, including project plans, operating procedures, runbooks, network diagrams, and scopes of work. - Perform other related duties as assigned by management. Qualifications - Bachelor’s degree from an accredited college or university in Computer Science, Information Technology, Business, or a related field; equivalent experience may be considered. - 10+ years of hands-on experience supporting IBM Power Systems environments. - Strong experience with IBM i and VIOS installation, administration, configuration, maintenance, and upgrades. - Experience installing, configuring, and managing high availability solutions such as MIMIX, PowerHA, SAN replication, and related technologies. - Ability to work independently with limited supervision while also collaborating effectively within a team environment. - Excellent interpersonal, verbal, and written communication skills. - Detail-oriented, organized, and proactive, with strong follow-through and time-management skills. - Demonstrated ability to prioritize competing demands in a fast-paced technical environment. - Strong work ethic and commitment to teamwork, accountability, and high-quality service delivery. Requirements - Core Operating Systems Expertise - IBM i (formerly AS/400, iSeries) - System Administration: Advanced administration of IBM i operating system versions, including PTF management, system sizing, performance monitoring, and hardware upgrade planning. - Work Management: Deep knowledge of subsystems, job queues, user profiles, class objects, and system values optimization. - Security & Compliance: Experience hardening operating system security, managing object authority, implementing audit controls, and supporting compliance requirements such as SOX and PCI-DSS. - Database Integration: Working knowledge of Db2 for i, SQL-based performance analysis, journaling, and commitment control. - IBM AIX (Advanced Interactive eXecutive) - OS Administration: Full-lifecycle administration of AIX environments, including NIM-based installation, patching, Technology Level upgrades, configuration, and operating system hardening. - Storage & Volume Management: Advanced proficiency with LVM, including management of physical volumes, volume groups, logical volumes, and JFS2 file systems. - Performance Monitoring & Tuning: Expert use of diagnostic tools such as NMON, topas, vmstat, iostat, and sar to identify and resolve performance bottlenecks. - Hardware and Virtualization (IBM Power Systems) - IBM Power Hardware: Comprehensive experience with enterprise IBM Power Systems and related hardware components. - HMC: Senior-level proficiency managing Hardware Management Console environments, including creation, configuration, and dynamic allocation of LPAR resources for CPU, memory, and I/O. - PowerVM: In-depth understanding of IBM Power virtualization technologies, including VIOS, NPIV, vSCSI, and Live Partition Mobility. - VIOS (Virtual I/O Server): Configuration, tuning, and maintenance of dual/redundant VIOS environments. - NPIV (N-Port ID Virtualization) & vSCSI: Fiber Channel mapping to LPARs. - LPM (Live Partition Mobility): Seamless migration of active partitions between physical hosts. - High Availability: Experience managing enterprise clustering and high availability environments, including PowerHA SystemMirror for AIX and IBM i. - Storage and SAN Infrastructure - Enterprise Storage Arrays: Experience with architecture, zoning, provisioning, and replication for enterprise storage platforms, including IBM FlashSystem, SAN Volume Controller, Dell EMC, and NetApp technologies. - SAN Switches & Fabric: Ability to design and manage Fibre Channel networks, administer Brocade or Cisco MDS fabrics. - Storage Optimization: Experience managing storage pools, thin provisioning, deduplication, replication, and flash copy technologies. - Enterprise Backup and Disaster Recovery (DR) - IBM Native Utilities: Advanced experience with native backup and recovery utilities, including mksysb and savevg for AIX and full system saves for IBM i. - IBM BRMS: Experience architecting and managing BRMS policy configuration, media management, automation, and daily operational processes. - Hardware Data Protection: Administration of physical and virtual tape libraries, enterprise tape systems, and SAN-level replication technologies such as Global Mirror and Metro Mirror. - Disaster Recovery Testing: Design, maintain, and execute disaster recovery and bare-metal restore plans that support defined recovery time objectives and recovery point objectives. - Automation and Soft Skills - Automation/Scripting: Proficiency writing operational scripts to streamline routine tasks using KornShell, Bash, Perl, or Python. Experience with configuration management tools such as Ansible for IBM Power environments is preferred. - ITIL Framework: Working knowledge of ITIL service management practices, particularly incident, problem, and change management using tools such as ServiceNow or Jira. - Mentorship & Collaboration: Ability to serve as a senior technical escalation resource, create clear documentation and runbooks, and mentor junior administrators. Benefits - Competitive salary and performance-based bonuses. - Comprehensive health, dental, and vision insurance. - 401(k) retirement plan with company match. - Flexible work hours and remote work options. - Professional development opportunities and training programs. Company Description CloudFirst is a leading managed cloud, cybersecurity, and infrastructure services provider focused on helping midsize enterprises modernize operations, improve resiliency, and accelerate business growth. The company delivers secure, scalable, and compliant IT solutions that allow organizations to focus on innovation while CloudFirst manages mission-critical infrastructure, cybersecurity, and operational performance.

Role Description Our client is an innovative manufacturer of medical devices in the United States which produces devices and software applications. At this project, you will have a great opportunity to be involved in the full development life cycle of medical software which is intended to help individuals by processing certain information taken from medical devices to identify health trends and track daily activities. Qualifications - At least 2-5 years of IT industry experience (Software Quality Assurance Engineer/Analyst/process engineer or similar position from Quality Assurance or Process Management sphere) or as a quality/certification/process/metrology specialist in other domains is a must; - Strong knowledge, deep understanding, and practical application (implementation, support) of international quality management system standards and regulations (e.g. ISO 9001:2015, ISO 13485); - Experience in auditing/assessment of Quality Management System based on international quality management system standards (e.g. ISO 9001:2015, ISO 13485, FDA Quality System Regulation (21 CFR Part 820)); - Experience in preparation/review of product-specific lifecycle documentation intended to confirm quality of the product; - Good understanding of Risk Management principles and techniques (Failure Mode and Effect Analysis (FMEA), FTA and other); - Good understanding of medical device SQA principles and related regulations: ISO 13485, IEC 62304, ISO 14971, FDA QSR Part 820, EU MDR; - Good understanding of software V&V methodologies and software development life cycle; - Good understanding of software testing principles; - Ability to work with big amounts of information, produce and organize content in a logical flow; - Strong documentation management skills, ability to review, analyze and interpret complex and complicated documents; - Good analytical skills; - Attention to detail and being a kind of perfectionist; - Ability to cope with quite routine work; - Team player; - English: Upper Intermediate or higher; ability to communicate with native speakers is a must; Requirements - Leading review and approve of project documentation (such as development plans and reports, verification test plans and reports etc.), providing feedback and support team in order to ensure timely preparation and readiness of project deliverables; - Review and approve of CSV documentation; - Assessing project activities and deliverables against established procedures, standards and regulations as per established QMS; - Advising R&D team regarding implementation or adjustment of established processes; - Work closely with engineering, product, and support teams to ensure the quality and accuracy of project deliverables; - Communicating with a customer on quality assurance, process management, documentation preparation topics; - You will collaborate with R&D and product management teams to ensure robust quality processes and regulatory compliance; - This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions. Benefits - Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people's lives. - Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success. - DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment. - Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm. - Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment. - Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.

Role Description The CJIS Application Tester will be responsible for system testing, User Acceptance Testing (UAT), and validation of system requirements for the Connecticut Information Sharing System and other CJIS-managed applications. This role requires a strong understanding of enterprise-level system integration, API testing, automation framework development, and data validation. The tester will work closely with developers, project managers, and stakeholders to ensure system reliability, performance, and compliance with CJIS standards. Qualifications - Bachelor's degree in Computer Technology, Computer Science, or related field. - 5-7 years of experience in software testing or QA engineering within IT projects. - Experience testing large integrated enterprise systems. - Strong knowledge of automation testing frameworks. - Proficiency in Java or C# programming. - Experience with data-driven automation testing. - Knowledge of Extent Reports or similar automation reporting tools. - Experience with GitHub for version control. - Experience with SoapUI, Postman, and defect management tools. - Experience with IBM Rational Jazz Suite (preferred). - Experience with NIEM XML or complex XML standards. - Knowledge of Service-Oriented Architecture (SOA). - Ability to write complex SQL queries using Microsoft SQL Server. - Strong experience with API and web service testing. - Strong analytical and problem-solving abilities. - Excellent documentation and communication skills. - Ability to work effectively in cross-functional teams. - Proficiency in Microsoft Excel. Requirements - Strong understanding of enterprise-level system integration. - Experience with automation framework development. - Ability to ensure system reliability, performance, and compliance with CJIS standards. Benefits - Competitive salary. - Health and wellness programs. - Opportunities for professional development.