Test engineer jobs in Pawtucket, RI

first PRO is now accepting resumes for a Manual Quality Assurance Engineer role in Boston, MA. This is a 6+month contract and onsite. Local candidates only. Based on project requirements and technical design, develop, document, and execute detailed test plans, test cases, and test scripts based on requirements and specifications Participate in requirement reviews and provide quality input early in the process Plan test schedules & strategies in accordance with project scope & delivery dates Schedule and review test plan review with project manager, business analyst, and UAT Lead Desired Skills 6-10 years testing and/or Property & Casualty Insurance experience Experience with Quality Center/ALM for requirements, test case and defect management Data testing experience. Includes writing SQL and working with XML files

A leading quantum/photonics hardware company is building an interconnect fabrication team in Boston and is looking for a Photonics Test Engineer to own test strategy and execution for next‑generation optical interposers and silicon photonics interconnects. In this position, you would define and implement optical/electrical test plans from wafer‑level through package‑level, work closely with OSAT partners on test flows and yield ramps, and translate test data into clear feedback for process, design, and packaging. Experience working with OSATs (process control, test spec definition, data review) and hands‑on silicon photonics test (coupling, loss budgets, BER/eye measurements, automation) would be especially valuable. If you enjoy sitting at the junction of fab, packaging, and test-helping to turn advanced silicon photonics designs into reliable, scalable interconnect products-this could be a very high‑impact move.

ETL DataStage Tester Domain - Life science ETL testing DataStage Testing DBT Snowflake Reporting tools (Tableau, Power BI, etc.) SQL queries Database testing Log, track, and manage defects identified during the testing cycle using tools like Jira or ALM. Utilize SQL extensively to query relational databases (e.g., Oracle, SQL Server, Teradata) for data validation.

Job Title / Role: Embedded Tester Key Skills: (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools) Experience: A minimum of 8 years related experience is required. Shift: 8 AM - 5 PM We at Coforge are seeking seeking a highly skilled Embedded Tester with expertise in Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools Roles & Responsibilities: Experience in Embedded device /Hardware Testing knowledge Ability to perform Whitebox testing, unit testing Hands on experience in mobile app or mobile device testing. Hands on experience in Python/Appium is added advantage. Experience on working, Test Hardware and boards Perform end-to-end functional testing and validation for the applications under test. Execute test cases for products under development using test management/tracking tools Create and maintain cases, scenarios/scripts, in compliance with defined QA standards and methodologies Establish and configure testing environments for executing test cases and scenarios Track quality assurance metrics such as defect densities, open defect count, code coverage Good To Have Skill sets: Experience with Healthcare Domain and FDA's device testing lifecycle. Experience working in an Agile environment - active participation in Sprint Planning, Backlog Grooming, Standups, Review and Retrospect Ability to take direction from designated IT Leadership, and work closely with BU Lead, as necessary. Is innovative, can simplify, and has relentlessly high standards Ability to review business requirements, identify ambiguity and request written clarification as required. Ability to work with various teams, SMEs to clarify and resolve testing issues. Excellent written and communication skills. Personal drive for individual and team success by meeting required priorities and deadlines with quality work. Assertive when required to ensure project success. Contact information: Looking forward to receiving your profile, for more details please email at *****************************

DeltaV Automation Engineer Experience Levels: Mid-Level: 3-7 years Senior: 7-14 years Principal: 14+ years A leading engineering and consulting firm in the life sciences sector is seeking experienced DeltaV Automation Engineers to support projects in the biotech and pharmaceutical industries. With over two decades of global experience, the firm specializes in manufacturing applications including process automation, MES, data analytics, and project management. This is an excellent opportunity to join a dynamic team working on the design, automation, commissioning, and startup of cutting-edge facilities and systems. The ideal candidate will bring strong technical expertise, hands-on automation skills, and solid documentation capabilities. Key Responsibilities Design, configure, and implement process control solutions for life sciences manufacturing Program, test, and document Emerson DeltaV DCS systems Develop user requirements, software/hardware design specifications, and validation protocols Create electrical panel schematics and scope of supply documentation Lead and manage automation projects, ensuring timely progress and delivery Support on-site installation, testing, and startup of control systems Collaborate with plant engineers and operators to optimize control strategies Provide training to operators and engineering staff on control systems Qualifications Bachelor's or Master's degree in Mechanical, Chemical, or related Engineering discipline Proven experience in the biotech/pharma industry Strong understanding of S88 Batch structure and DeltaV architecture Proficient in reading and interpreting P&IDs and automation narratives Hands-on experience with commissioning and startup of control systems Familiarity with PLC, HMI, and SCADA platforms (Rockwell, Siemens, Wonderware, GE) Knowledge of control system networking (TCP/IP, Ethernet/IP, OPC UA, Profibus) Understanding of cGMP, FDA regulations, and 21 CFR Part 11 compliance

Work schedule: Hybrid Key Responsibilities: Performance Tuning: Monitor and optimize performance, including query performance, resource utilization, and storage management. User and Access Management: Manage user access, roles, and permissions to ensure data security and compliance with organizational policies. Data Integration: Support and manage data integration processes, including data loading, transformation, and extraction. Troubleshooting and Support: Provide technical support and troubleshooting for Snowflake-related issues, including resolving performance bottlenecks and query optimization. Documentation and Reporting: Maintain detailed documentation of system configurations, procedures, and changes. Generate and deliver regular reports on system performance and usage. Collaboration: Work closely with data engineers, analysts, and other IT professionals to ensure seamless integration and optimal performance of the Snowflake environment. Best Practices: Stay up to date with Snowflake best practices and industry trends. Recommend and implement improvements and upgrades to enhance system functionality and performance. Qualifications and Experience: 5+ years of experience in data architecture, data engineering, or database development. 2+ years of hands-on experience with Snowflake, including data modeling, performance tuning, and security. At a minimum Bachelor's degree in Computer Science, Information Technology, or related field. Experience with source control tools (GitHub preferred), ETL/ELT tools and cloud platforms (AWS preferred). Experience or exposure to AI tools. Deep understanding of data warehousing concepts, dimensional modeling, and analytics. Excellent problem-solving and communication skills. Experience integrating Snowflake with BI and reporting tools is a plus Required Skills: Strong proficiency in Snowflake architecture, features, and capabilities. Knowledge of SQL and Snowflake-specific query optimization. Experience with ETL tools and data integration processes. Strong proficiency in SQL and Python. Strong Database design and data modelling experience. Experience with data modeling tools. Ability to identify and drive continuous improvements. Strong problem solving and analytical skills. Demonstrated process-oriented and strategic thinking skills. Strong motivation and a desire to continuously learn and grow. Knowledge of Snowflake security features including access control, authentication, authorization, encryption, masking, secure view, etc. Experience working in AWS cloud environments. Experience working with Power BI and other BI, data visualization, and reporting tools. Business requirement gathering and aligning to solutions delivery. Experience with data integration solutions and tools, data pipelines, and modern ways of automating data using cloud based and on-premises technologies. Experience integrating Snowflake with an identity and access management program such as Azure IDP is a plus. Experience with other relational database management systems, cloud data warehouses and big data platforms is a plus. Analytical Skills: Excellent problem-solving and analytical skills with strong attention to detail. Communication: Effective communication skills, both written and verbal, with the ability to convey complex technical information to non-technical stakeholders. Teamwork: Ability to work independently and collaboratively in a fast-paced environment. Preferred Skills: Snowflake certification (e.g., SnowPro Core or Advanced Certification).

Must Have: Bachelor's degree in computer science, or a related field 5-8 years of experience designing, developing, and deploying API integrations within the financial services industry. Experience with financial data, including instruments, transactions, and positions. Demonstrates expertise in MuleSoft Anypoint Platform, including API design, development, and management. Project experience with building service APIs & messaging integration patterns using MuleSoft. Agile methodologies (Scrum, Kanban) and DevOps principles. Solid programming languages like Java, Python, or JavaScript and has experience with REST and SOAP APIs. Has experience with cloud platforms (AWS, Azure, GCP) and understands integration patterns for cloud-native environments. Strong understanding of data modeling concepts and data transformation techniques (e.g., JSON, XML, XSLT). Collaborative work environment and enjoys fast-paced, result-oriented settings. Demonstrates excellent communication and interpersonal skills to effectively collaborate with stakeholders. Contract role (W2 or C2C). Hybrid schedule with 3 days onsite in Boston. Must reside in the Boston area

Title: Validation Engineer Duration: 6m+ There are 3 roles open here - 2 beginner level (not entirely green but 1-2 yrs is fine) and 1 intermediate level (4+ yrs) KEY RESPONSIBILITIES: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of Analytical Instrument and Manufacturing equipment. Support all stages of qualification of automated manufacturing equipment Conduct Analytical Instrumentation Qualifications in accordance with USP and Vertex SOPs. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes assigned training and ensures that they are 100% compliant 100% of the time. Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines. Supports right-the-first time culture for all documents distributed across the organization. Ensure the Validation team reputation and partnership is flourished with the cross-functional teams. IDEAL CANDIDATES: Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment. Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas. Receptive to change - Adapts (quickly) to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

Veteran-Owned Firm Seeking a System Cybersecurity Engineer II for an Onsite Assignment at Hanscom Air Force Base (AFB) My name is Stephen Hrutka. I lead a Veteran-Owned management consulting firm in Washington, DC. We specialize in Technical and Cleared Recruiting for the Department of Defense (DoD), the Intelligence Community (IC), and other advanced defense agencies. At HRUCKUS, we support fellow Veteran-Owned businesses by helping them recruit for positions across organizations such as the VA, SBA, HHS, DARPA, and other leading-edge R&D-focused defense agencies. We seek to fill a System Cybersecurity Engineer II role at Hanscom Air Force Base (AFB) in Bedford, MA. The ideal candidate must have an active Secret Security Clearance, a DoD 8570.01-M MGT512-compliant certification, and experience with LogRhythm. Required qualifications include either a BA/BS with 10 years of cybersecurity experience (5 in DoD), an MA/MS with 5 years (3 in DoD), or 15 years of related experience with proper certifications, including 5 years in DoD. If you're interested, I'll gladly provide more details about the role and discuss your qualifications further. Thanks, Stephen M Hrutka Principal Consultant HRUCKUS LLC Executive Summary: HRUCKUS is seeking a System Cybersecurity Engineer II with Secret Clearance for a role at Hanscom Air Force Base (AFB) in Bedford, MA. Position Overview: The System Cybersecurity Engineer II will be able to perform work that involves ensuring the confidentiality, integrity, and availability of systems, networks, and data through the planning, analysis, development, implementation, maintenance, and enhancement of information systems security programs, policies, procedures, and tools. Position Responsibilities: Supporting the system/application authorization and accreditation (A&A) effort, to include assessing and guiding the quality and completeness of A&A activities, tasks, and resulting artifacts mandated by governing DoD and Air Force policies (i.e., Risk Management Framework (RMF). Recommending policies and procedures to ensure the reliability of and accessibility to information systems and to prevent and defend against unauthorized access to systems, networks, and data. Conducting risk and vulnerability assessments of planned and installed information systems to identify vulnerabilities, risks, and protection needs. Promoting awareness of security issues among management and ensuring sound security principles are reflected in organizations' visions and goals. Conducting systems security evaluations, audits, and reviews. Recommending systems security contingency plans and disaster recovery procedures. Recommending and implementing programs to ensure that systems, networks, and data users are aware of, understand, and adhere to systems security policies and procedures. Participating in network and systems design to ensure implementation of appropriate systems security policies. Facilitating the gathering, analysis, and preservation of evidence used in the prosecution of computer crimes. Assessing security events to determine impact and implementing corrective actions. Ensuring the rigorous application of information security/cybersecurity policies, principles, and practices in the delivery of all IT services. Perform the Information System Security Engineer (ISSE) duties in an Information Assurance Workforce System Architecture and Engineering (IASAE) position as outlined in AFI 33-200, AFI 33-210 and AFMAN 33-285 for assigned systems. Perform the Information System Security Manager (ISSM) duties as outlined in DoDI 8510.01 for assigned systems/applications. Perform the Information System Security Officer (ISSO) duties as outlined in DoDI 8510.01 for assigned systems/applications. Other duties as assigned. Required Qualifications: Clearance: Active Secret Security Clearance BA/BS degree with a minimum of 10 years of cybersecurity experience, including 5 years supporting the Department of Defense (DoD); or an MA/MS degree with at least 5 years of experience, including 3 years in a DoD environment; or 15 years of directly related experience with the appropriate certifications, of which a minimum of 5 years must be within the DoD. DoD 8570.01 MMGT512 compliant certification. Experience with LogRhythm. Lab/SCIT management experience preferred. Experience with the Risk Management Framework (RMF). Details: Job Title: System Cybersecurity Engineer II Location: Hanscom Air Force Base, MA Clearance Requirement: Active Secret Clearance Assignment Type: Full-time, Onsite Salary Range: $130,000 - $140,000 per year

Job Title: Artificial Intelligence Engineer Location: Boston/Hybrid Type: Full-time The Role We're looking for a hands-on AI Systems Engineer to own the deployment, integration, and support of AI-powered tools (LLMs, Copilot, Claude, etc.) while keeping enterprise infrastructure running smoothly in a professional services environment. What You'll Do Build, deploy, and maintain AI applications that supercharge legal and knowledge workflows Manage and optimize cloud (Azure/M365) and on-prem environments (Windows/Linux, VMware/Nutanix, AD, SQL) Write production-grade Python/PowerShell, automate everything, consume REST APIs and SDKs Craft high-impact prompts and fine-tune LLM usage Partner with architecture and ops leadership on strategy, resilience, and continual improvement Research emerging tech and drive efficiency gains Rotate in 24×7 on-call (escalation/triage) You Bring 7+ years supporting mission-critical IT in professional services or similar Real experience with modern LLMs and AI tools Strong Python or PowerShell + familiarity with ML libraries Deep experience with Azure, M365, Active Directory, virtualization, networking, backups Proven ability to solve complex problems independently and communicate clearly Bachelor's in CS or related field

💻 Software Engineer | Scalable Systems | Onsite (Cambridge, MA) A rapidly growing tech startup is building AI-driven, high-performance systems designed to solve complex, real-world challenges. The team blends software engineering and systems optimization to create scalable, reliable technology that supports next-generation applications. As a Software Engineer, you'll play a key role in designing and building scalable front-end and back-end systems in TypeScript, collaborating with talented engineers to deliver secure and efficient solutions that perform at scale. Tech: TypeScript, React, and Node.js If you enjoy building scalable systems that drive innovation and want to make a visible impact in a fast-moving startup, this could be the perfect fit. 📍 Location: Cambridge, MA (onsite) 💰 Up to $300,000 (dependant on exp.) + equity options Interested? Apply now!

This role is with a DeWinter Investment Management Partner Boston, MA - Hybrid Role - We are targeting local candidates that can be in the Boston office 3 days per week. 12 Month + contract (or contract to hire, if desired) Position Summary We're seeking a senior, full-stack engineer using React and Python for our portfolio management and tools team, These tools are used for company wide investing strategies. Prior domain experience is not required. Key Responsibilities Design and build new tools to attribute portfolio performance and risk across alpha, transaction, liquidity, and risk models for quantitative investment strategies. Support and drive research initiatives that improve the investment process based on insights from attribution systems. Develop scalable, full-stack applications using Python, React, and JavaScript. Architect robust backend solutions leveraging Python and both relational and non-relational databases for high-performance data processing. Unify and optimize reporting across global strategies and workflows, including exception-driven reports. Implement cloud-ready solutions that adapt to evolving investment needs. Work with APIs and data structures to deliver real-time portfolio insights. Maintain and enhance an internal configuration-based language for portfolio analytics. Partner closely with portfolio managers, quantitative researchers, and engineers to align tools with real-world investment workflows. Qualifications Bachelor's degree in a relevant field; CFA progress a plus. 4-6 years of experience in full-stack or portfolio tools development using modern technologies. Strong backend engineering skills, including distributed computing and API design. Familiarity with investment concepts such as attribution and risk analysis. Demonstrated ability to build fast, maintainable, and scalable systems deployed in cloud environments.

Join a mission-driven engineering team building next-generation technology for diagnosing and treating cardiac arrhythmias. You'll help develop a real-time medical platform that blends advanced visualization, hardware integration, and life-saving clinical workflows. This onsite/hybrid role (4 days per week in Greater Boston) offers close collaboration, hands-on lab work, and the opportunity to shape a high-impact medical system from the ground up. What we offer you in USA We honor the contract terms you prefer. 20 paid vacation days per year 40 working hours per week Retirement Plan 401(K) Medical, Dental, Vision Insurance Plan for you and your Family 100% On-Site position in Newton What You'll Do Design, implement, and optimize high-performance system software in Python and C++. Build and debug applications that interface directly with medical hardware, imaging systems, and embedded components. Collaborate with hardware, systems, product, and QA teams to define requirements and deliver clinically reliable software. Drive engineering quality through code reviews, automated testing, and CI/CD. Mentor junior engineers and contribute to a culture of technical excellence. Document architecture, design decisions, and verification processes for regulatory compliance. Support lab evaluations, pre-clinical studies, and customer-facing demos. Stay current on tools and frameworks to help advance system performance and scalability. Required Qualifications Bachelor's + 4 years of experience, or Master's + 2 years, or PhD with relevant work or research experience. Strong proficiency in Python and C++. Preferred Qualifications Expertise in OOP, algorithms, and data structures. Experience with real-time or embedded software development. Familiarity with network protocols and hardware/software integration. Hands-on experience with ROS, Linux development, and/or RTOS. Knowledge of Git, CI/CD pipelines, Agile workflows. Exposure to cloud platforms (AWS/Azure) and scalable architectures. Strong communication and cross-functional collaboration skills. Ability to take ownership of complex, mission-critical software modules.

Senior Software Engineers - Relocate to NYC (Boston's Best Only) Industry: High-performance trading & research engineering Comp: $600k - $1.5m We're hiring a small number of exceptional Software Engineers to join a high-impact engineering group in NYC. If you're in Boston and operating well above average, this is where your ability actually gets used. What You'll Work On Serious engineering - not feature factory work: Distributed computing & large-scale data systems Research/modelling platforms High-performance execution & routing Core infra powering real-time decisioning Small teams. High autonomy. Immediate impact. Who Should Apply Engineers with clear, proven excellence, typically shown through: Elite Foundations Top CS/Math/EE degree (MIT/Harvard/CMU/Stanford/etc. or equivalent) Strong GPA (usually 3.7+ or equivalent) Real Engineering Depth Distributed systems, infra, platform, HPC, research tooling or similar Ownership of complex, performance-critical systems Fast progression + high trust roles High Problem-Solving Ability Algorithms, systems thinking, clean architecture, first-principle reasoning. Commercial Awareness You build with purpose - speed, correctness, and impact matter to you. Not a Fit Web dev only, Maintenance roles, Anyone not relocating to NYC What You Get Market-leading comp NYC relocation High-calibre peers Work that hits production fast A genuinely career-defining engineering environment If You're One of Boston's Top Engineers - Apply.

Systems Engineers Nationwide Opportunities Are you a technically minded problem solver who thrives on designing, integrating, and optimizing complex systems? Whether your expertise lies in pharma, medical device, med tech, or advanced manufacturing, we'd love to connect. At Scientific Search, we partner with innovative companies across the U.S. who rely on Systems Engineers to bridge the gap between hardware, software, and process - and we're continually supporting searches for these critical roles. We're always interested in speaking with Systems Engineers experienced in: Designing and implementing automated or integrated systems Supporting equipment or process validation and system-level troubleshooting Working cross-functionally with R&D, manufacturing, and quality teams Ensuring reliability, scalability, and compliance within regulated environments If you'd like to be considered for future Systems Engineer roles, we'd love to review your background and keep you in mind as new opportunities arise. Submit your resume We're always expanding our network of talented engineers - let's stay in touch so we can connect you with the right role when it's available. #19577

Systems Engineer Contract-to-Hire Boston-based 1x per week onsite We're looking for a hands-on Systems Engineer with broad experience across Windows Server, Active Directory, virtualization, and endpoint management. You will be responsible for maintaining, supporting, and improving a large and active IT environment. Role Administer and maintain Windows servers, Active Directory, and group policies Support virtualization platforms such as VMware or Hyper-V Manage endpoint systems including SCCM, Intune, and patching cycles Handle backup, monitoring, and basic networking tasks Build and maintain automation scripts for routine tasks and deployments Troubleshoot system issues and implement long-term solutions Participate in projects to modernize and optimize the IT estate Responsibilities Strong hands-on experience with Windows Server and Active Directory Solid knowledge of endpoint management (SCCM, Intune, or similar) Experience with virtualization platforms (VMware or Hyper-V) Familiarity with patch management, backup, and monitoring tools Comfortable with scripting (PowerShell, Python, or similar) Able to work independently and take ownership of issues Exposure to cloud environments (Azure, AWS) is a plus If you're a proactive engineer who enjoys a varied role across servers, endpoints, and virtualization, this is a great opportunity to make an impact. Apply today.

Title: System Engineer Duration: Full-Time Responsibilities Help to translate consumer and stakeholder needs into product requirements, manage requirement change process, and decompose system level requirements to subsystems, modules, and components. Create system architectures that will deliver product features and functionality. Cascade subsystem requirements to platform owners and manage interfaces between subsystems. Identify and charter R&D efforts for all new innovations required to meet program goals. Engage external partners when needed to execute these programs. Assist with learning plan development and prioritization to drive decision making at schedule intervals. Assist with risk analysis mitigation, and validation plans. Lead teams through engineering development using LAMDA/DAMAICor similar systematic tools. Make data driven decisions using the Six Sigma toolbox and coach others in the use of six sigma tools and methods. Have a hands on approach with prototyping and testing. Communicate development progress to senior leadership. The Senior Systems Engineer is required to be hands on with prototypes and testing during development. Support organizational continuous improvement projects to evolve our ways of working. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Requirements: MS or BS in Engineering with 10+ years of engineering experience preferably in high volume consumer product development. Six Sigma Green Belt or Black Belt Certification Experience using statistical software tools like JMP, Minitab, or R Expert level 3D modeling experience (Solidworks preferred). General understanding of systems modeling and finite element methods. A breadth of understanding of all engineering disciplines with strong depth in one or more. Experience leading DFMEA activities and creating validation plans. Proven experience building prototypes, test fixtures, and running experiments. Excellent verbal and written communication skills.

first PRO is now accepting resumes for a Software Engineer in Test role in Somerville, MA. This is a direct hire role with a hybrid workstyle. Quality and Best Practices Champion Promotes automation first approach to test plans that incorporate both positive and negative scenarios Identifies functional interdependencies between squads that optimizes testing of related/dependent features that are cross-squad and cross-team Participates and leads in postmortem activities to better understand and automate escapes and implement process improvements Understands each tier of the testing pyramid and the how to use the different automation solutions for them Helps ensure both stories and epics meet both Definition of Ready (DoR) and Definition of Done (DoD) Applies test-first BDD and TDD best practices EXPERIENCE/EDUCATIONAL REQUIREMENTS: Bachelor's/Master's degree in the Hard Sciences (Computer Science, Math, Engineering preferred) 10+ years of software development or automation development or technical team leadership experience Demonstrable experience with some of CI/CD, BDD/TDD, C#, Relational Databases and Python/JavaScript Experience with performance tools like Neoload/JMeter/Etc Familiarity with Playwright

Execute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review. Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards. Perform equipment and analytical instrument qualification following regulatory and internal guidelines. Conduct automation and software compliance assessments to ensure adherence to 21 CFR Part 11 requirements. Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete CQV (Commissioning, Qualification & Validation) tasks. Support validation of automated manufacturing systems and sterile process controls. Maintain accurate, audit-ready validation documentation in compliance with quality system requirements. Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek. Ensure all work aligns with applicable SOPs, regulations, and Good Documentation Practices (GDP).