Validation engineer jobs near me - 325 jobs

A leading insurance solutions provider seeks a Lead Engineer to head the development of new AI products. This role involves hands-on engineering work, defining system designs, and collaborating closely with product and design teams. Ideal candidates have 7+ years experience, particularly with AI-powered systems, and must possess strong programming skills, especially in Python. This is a remote position with a competitive salary range of $106,561-$180,645 annually. #J-18808-Ljbffr

A tech company focused on sales performance is seeking a Site Reliability Engineer in San Francisco. This role involves collaborating with development teams, automating infrastructure, and ensuring service reliability. Ideal candidates will have extensive experience in SRE or DevOps, with skills in infrastructure as code and strong communication abilities. The company offers generous benefits including health coverage and a 401k plan, fostering a diverse and inclusive work environment. #J-18808-Ljbffr

We're building the creative layer for modern communication. Every month, over a billion people make presentations - but the tools they use to make them haven't evolved in decades. We're changing that, using AI to disrupt a massive market. 📈 Millions of people rely on Gamma to create, teach, and persuade, creating more than 1 million gammas every day. 💻 We see Gamma as the next great workplace tool, combining viral B2C love with a massive B2B opportunity. We believe AI can be a true creative partner: one that understands context, clarity, and taste. 💸 We've reached a $2.1B valuation, crossed $100M in annual recurring revenue, and have been profitable since 2023. 💙 We're an imaginative, passionate team who takes our work seriously, but not ourselves. Our culture is warm, a little quirky, and fueled by curiosity. About the role Gamma's infrastructure needs to be rock-solid for millions of daily users while enabling our engineering teams to ship fast. You'll own the operational health of our full backend platform, building automation and tooling that improves reliability and partnering with engineering to design systems that are observable, resilient, and easy to operate. Your work directly impacts every Gamma user's experience. This is a high-impact role where you'll balance reliability with velocity, knowing when to move fast and when to prioritize stability. You'll lead incident response, drive systemic improvements, and help shape how Gamma scales to serve its next 100 million users. Our team has a strong in-office culture and works in person 4-5 days per week in San Francisco. We love working together to stay creative and connected, with flexibility to work from home when focus matters most. What you'll do Own reliability, availability, and performance of Gamma's production systems across primarily AWS infrastructure Build observability infrastructure with metrics, logging, tracing, and alerting that provide deep visibility into system health Design automation to reduce toil, improve deployment safety, and accelerate incident resolution Lead incident response, conduct blameless post-mortems, and drive systemic improvements to prevent recurring issues Partner with engineering teams on architecture reviews, SLOs/SLIs, and reliability best practices Manage and optimize our infrastructure including compute, networking, databases, and managed services What you'll bring 5+ years in Site Reliability Engineering, DevOps, or systems engineering roles with deep AWS expertise Strong programming skills (Python, Go, or TypeScript/Node.js) for building tools and automation Experience with infrastructure-as-code (Terraform, CloudFormation) and comprehensive observability solutions Track record improving system reliability through automation, monitoring, and architectural improvements Solid understanding of networking, distributed systems, containerization (Docker, Kubernetes), and database performance Strong incident management and debugging skills for complex production issues (Nice to have) Experience scaling SaaS applications to millions of users (Nice to have) Background with real-time collaborative systems, Kafka, chaos engineering, or service mesh technologies (Nice to have) AWS certifications or experience with security/compliance requirements (SOC 2, ISO 27001) Compensation range Final offer amounts are determined by multiple factors, including but not limited to experience and expertise in the requirements listed above. If you're interested in this role but you don't meet every requirement, we encourage you to apply anyway! We're always excited about meeting great people. We're building on a full Typescript stack centered around some of the most modern and popular technologies. We use our own custom, open-source AI prompting framework, AIJSX. We have a lot of custom tools built in-house, but also new ones like Vercel AI SDK. Our tiny team operates at massive scale: 1M+ 70M users around the world 6M+ AI images generated daily 1 trillion LLM tokens processed per month Life at Gamma You get energy from small teams doing big things. You love when design, code, and storytelling overlap. You default to action, even when the answer isn't clear yet. You value details, but know when to ship and move on. You bring both the spreadsheets and the sparkle, equal parts workhorse and unicorn. You believe AI should amplify creativity, not replace it. You know kindness and intensity are not opposites. You like working with people who care deeply: about their craft, their teammates, and the users on the other side of the screen. Who we are Gamma is full of imaginative, passionate people who take their work seriously but not themselves. The culture is warm, a little quirky, and fueled by curiosity. It's the kind of place where you'll debate a pixel on Monday, laugh over someone's keyboard setup on Tuesday, and ship something remarkable by Friday. We care about craft, move with intention, and don't mind getting a little scrappy. It's fast, creative, and occasionally chaotic - but that's what makes it interesting. Here's a bit about what it's like to work here, from people on the inside: “quirky, inspiring, fun, a little wild in the best way” “You can have an idea and just run with it.” “Everyone's talented and humble - the mix keeps you sharp.” “We ship cool stuff, learn a ton, and laugh a lot doing it.” Meet the team We're a team of dreamers and doers building in beautiful San Francisco 🌉 We're kabbadi enthusiasts, pickleballers, dog herders, woodworkers, keyboard nerds, potters, and more - and we can't wait to meet you! #J-18808-Ljbffr

We are a team of multidisciplinary experts in artificial intelligence, cryptography, and software engineering who collaborate to build solutions for unsolved problems in web3. We work on challenges such as trust-minimized micropayments, low-latency request processing, data verification, and dynamic pricing. We've published research at prestigious AI conferences like NeurIPS and developed novel optimization algorithms. We make web3 smarter and verifiable. We are a core developer of The Graph protocol ($1B+ market cap), an indexing protocol for organizing and accessing the world's data. We are also the parent company of Odos, a market-leading liquidity aggregator that supports $5B+ in monthly trading volume. You can learn more about Semiotic Labs at semiotic.ai or by watching this presentation. The Role We're looking for a Rust Engineer who's excited about building scalable, cryptographically secure systems for web3 infrastructure. You'll work on GraphTally, implementing performant, reliable components that enable stateless, one-way payment channels at scale. This role is ideal for someone who thrives on solving protocol design challenges and building robust, production-ready Rust code. This role is perfect for those who thrive in a multidisciplinary team solving complex, unsolved problems through research and engineering. You\'ll excel here if you're excited about working on a small, agile team where your daily work drives innovation-both internally and across the web3 ecosystem. Above all, you should be passionate about delivering real value to users. What You'll Do Design, implement, and maintain core components of the GraphTally protocol in Rust. Collaborate with researchers and protocol engineers to refine and evolve the architecture. Optimize signature verification, message processing, and batching for high-throughput performance. Implement secure state transition logic, trust-minimized payment flows, and smart contract interactions. Work closely with smart contract engineers to ensure seamless on-chain integration (mainly on L2s like Arbitrum). Write clean, testable, and efficient code with a focus on security and correctness. Contribute to technical documentation, specifications, and developer tooling to support GraphTally adoption. 3+ years of professional experience writing high-performance, production-quality async code in Rust. Experience in designing and implementing remote APIs (REST, JSON-RPC, gRPC). Experience in responsive microservices design and development. Experience with databases (Postgres, Redis). Experience with Docker. Deep understanding of cryptographic primitives, especially ECDSA and digital signature schemes. Proficient with Rust's async/await model, leveraging futures, tokio, or async-std. Understanding of asynchronous state machines for managing complex protocol flows. Familiarity with zero-knowledge proofs, state/payment channels, or escrow mechanisms is a plus. Strong grasp of trust-minimized systems, distributed protocols, or payment rails in a web3 context. Experience working with Ethereum L2s (like Arbitrum, Optimism) and integrating with smart contracts. Proficiency with testing, benchmarking, and debugging asynchronous Rust applications in the context of web3, using tools like Anvil. Clear communication, curiosity, and a strong sense of ownership. Bonus Points Familiarity with The Graph protocol or Indexer infrastructure. Exposure to decentralized microservice architectures or multi-agent systems. Prior work on gas-optimized smart contracts or cryptographic batch verification. Experience with zk SNARKs, RAVs, or verifiable off-chain aggregation techniques. Why Join Semiotic Labs Be part of a small, high-caliber team solving cutting-edge problems in decentralized infrastructure. Work on a deeply technical and meaningful mission that helps scale web3. Shape the direction of a foundational protocol used by agents and services across the ecosystem. Fully remote, async-friendly team with competitive compensation and token upside. #J-18808-Ljbffr

About Plural: The assets that produce, store, and consume electrons will define the next era of the economy. But today, financing these assets is slow, expensive, and fragmented-locked behind legacy intermediaries and limited access. Plural is passionately building the infrastructure to change that. We tokenize everything from solar projects to batteries to bitcoin mines, using smart contracts and programmable workflows to reduce friction and open access to capital. On Plural, the nodes of a distributed grid are financed by a network of institutional, individual, and DeFi investors. This approach lowers costs, increases transparency, and enables scalable capital formation for the energy transition-trusted, composable, and built for efficiency. The Opportunity: Plural is seeking an experienced UI / Product Engineer. You will: Build and maintain our existing Next.js Typescript React codebase to push out new features and slicken the UX. Optimize the UX to provide best in class experiences for both Institutional and DeFi users. DApp development-build and maintain UI components that connect to EVM-based smart contracts. Stay current with emerging technologies and industry trends to ensure our system remains cutting-edge. Qualifications: Required 4+ years of professional experience with TypeScript and React. 2+ years of experience developing TypeScript-based dApps. UX design experience with a strong eye for user-centric design. Power user of AI development tools like cursor and demonstrated ability to vibe code MVPs quickly Hungry, driven self-starter with demonstrated track record of high agency and attention to detail Bonus: Experience at an exchange or DeFi company Experience with Next.js, Django, python What We Offer: Competitive salary and equity options Thoughtful technical and soft skill mentorship from experienced leaders Innovative Culture-we are a supportive and collaborative team pushing the boundaries of finance with blockchain. Apply: If you have what it takes, send your resume and a snippet about yourself to ************************* with subject line "Lead Product Engineer - [Your Name]"! #J-18808-Ljbffr

A leading AI solutions firm is looking for a JavaScript Developer to work remotely on AI-related projects. The successful candidate will review AI-generated JavaScript code, develop high-quality solutions, and create explanations for code logic. A Bachelor's degree in Computer Science and 3-5 years of experience with JavaScript frameworks like React or Node.js are required. This hourly contract offers flexible working hours ranging from 10 to 40 hours per week. #J-18808-Ljbffr

Job Title: Embedded Test Engineer Duration: Long Term Honda is seeking an experienced Test Engineer to develop and perform validation tests on mechanical and electrical components. The ideal candidate will design test plans, conduct tests, analyze results, and provide feedback to ensure products meet performance, reliability, and quality standards. Responsibilities: Develop and execute test plans and procedures for component and system validation Conduct data analysis and report findings to engineering teams Identify performance or reliability issues and recommend design improvements Operate and configure test equipment and data acquisition systems Document and present test results clearly and accurately Qualifications: BS in Mechanical or Electrical Engineering, or 6 years of related experience 5+ years of hands-on test engineering experience Proficient with INCA, CANalyzer, CANoe Programming experience in C, C#, C++, or Python Knowledge of microcontroller I/O, control logic, and calibration testing

Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials. What You'll Do As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Lead Validation Specialist Location: Princeton NJ and Remote - Preference given to applicants residing in the East Coast. We are seeking an experienced Senior Validation Specialist with experience in clinical systems to join our team. In this role, you will provide project leadership for the validation team and be responsible for ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11. You'll work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards. You'll be responsible for creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly. This is an ideal opportunity for someone who thrives in fast-paced, dynamic environments where adaptability, critical thinking, and initiative are essential. What You Need Bachelor's degree 8+ years prior experience inclusive of computer systems validation 5+ Years relevant experience in Leading a Validation Team Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+ Knowledge and understanding of Regulatory Guidelines for the use of computer systems Experience working with GxP regulations and 21 CFR Part 11 Experience mentoring and coaching teams Prior experience working in a Life Science regulated industry Prior project management experience, preferred Skills and Competencies Computer Systems and Technology: Strong knowledge of computer systems validation (SDLC, Agile methodologies) web technology, and cloud-based systems and proficiency with Computer skills including advanced knowledge of excel (e.g. Microsoft Word, Excel spreadsheets, PowerPoint, SQL) Analytical and Problem-Solving Skills: Ability to research, analyze system requirements, develop alternatives, and implement solutions Communication and Interpersonal Skills: Strong verbal and written communication skills as well the ability to work both independently and with cross-functional teams Time Management Skills: Highly organized, result-oriented, and a self-starter comfortable working in fast-paced environment with evolving priorities Additional Requirements Able to work effectively as an onsite or remote worker Must be highly fluent in English Willing to travel to meetings in Princeton, NJ as needed. Advance notice will be provided What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-150,000 with bonus potential. The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role. This position is not eligible for relocation or company provided sponsorship. Theradex is an Equal Opportunity Employer.

Lattice Overview There is energy here…energy you can feel crackling at any of our international locations. It's an energy generated by enthusiasm for our work, for our teams, for our results, and for our customers. Lattice is a worldwide community of engineers, designers, and manufacturing operations specialists in partnership with world-class sales, marketing, and support teams, who are developing programmable logic solutions that are changing the industry. Our focus is on R&D, product innovation, and customer service, and to that focus, we bring total commitment and a keenly sharp competitive personality.Energy feeds on energy. If you flourish in a fast paced, results-oriented environment, if you want to achieve individual success within a “team first” organization, and if you believe you can contribute and succeed in a demanding yet collegial atmosphere, then Lattice may well be just what you're looking for. Responsibilities & Skills What Will You Get to Do? Do you have a passion for invention and self-challenge? This position gives you an opportunity to learn and participate in one of the most cutting-edge projects that Lattice's Silicon Engineering team has embarked upon to date. We are validating building blocks in FPGA on board level to ensure functionality and performance aspect of Design intent. FPGA consists of various IPs as a building block such as SERDES(PMA/PCS), Memory DDR(DDR4, LPDDR4, DDR5 etc), DPHY, PLL, DSP, Fabric, I/O etc. As a Silicon Design Validation engineer, you will have an opportunity to learn and train yourself on how to validate one/or many of the building blocks within the FPGA. And also, you will be able to acquire knowledge on process/methodology required for validating certain IPs from planning to completion. While you are working on those, you will be exposed to cutting edge equipment and advanced boards as well as Various SW/tools/scripts. What you're going to be exposed to and learn: The ideal candidate is highly motivated in developing a career in Silicon Design Validation engineering. You will get significant exposure and training in the following areas: Chance to learn FPGA and it's build block such as SERDES(PMA/PCS), Memory DDR(DDR4, LPDDR4, DDR5 etc), DPHY, PLL, DSP, MIPI, Fabric, I/O etc but not limited. Validate and characterize various IPs from silicon arrival to release to production. Develop validation and characterization plans for certain IP, bench hardware and software. Develop test logic RTL to achieve intended validation/characterization test. Drive new silicon product bring-up, validation, debug to asses IP functionality/performance. Characterizing data sheet parameters. Analyzing the measured data with statistical view. Data sheet preparation etc. Serve as the central resource with design, verification, manufacturing, test, quality and marketing/apps as the product(s) move Silicon arrival to product release. Supporting customer issues as required to resolve issues found after product release You Have… 8+ years of experience Electrical Engineering degree with a strong desire to pursue an engineering career in Silicon Design Validation Capability to lead small group of teams as tech lead. Expertise in High Speed Serdes Interface characterization and protocol compliance testing such as PCIe/Ethernet/SDI/CoaXpress/JESD204, MIPI D-PHY, MIPI CSI/DSI-2, USB and DisplayPort/HDMI etc. Expertise in high speed board design and signal integrity evaluation/debug. Expertise in Verilog/VHDL and design implementation using FPGA development tools. Expertise in test automation development using programming languages such as Python, Perl. Knowledge of statistical analysis concepts and use of analysis tools such as JMP, R. Proficiency with bench equipment for device characterization such as BERT, VNA, Oscilloscopes, Protocol Exerciser/Analyzers. Exposure on FPGA(emulation/prototyping etc) Strong written and verbal communication skills to work with cross-functional team Self-motivated and proactive with critical thinking. Good problem solving and debugging skills. Benefits Benefits: The base pay for this role is between $144,000 to $180,000 per year. In addition to base salary, we offer an incentive plan bonus, and new hire equity for a competitive total compensation package. Lattice recognizes that employees are its greatest asset and the driving force behind success in a highly competitive, global industry. Lattice continually strives to provide a comprehensive compensation and benefits program to attract, retain, motivate, reward and celebrate the highest caliber employees in the industry. Lattice is an international, service-driven developer of innovative low cost, low power programmable design solutions. Our global workforce, some 800 strong, shares a total commitment to customer success and an unbending will to win. For more information about how our FPGA, CPLD and programmable power management devices help our customers unlock their innovation, visit ******************** You can also follow us via Twitter, Facebook, or RSS. At Lattice, we value the diversity of individuals, ideas, perspectives, insights and values, and what they bring to the workplace. Applications are welcome from all qualified candidates. Lattice Feel the energy.

The Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance. Here's What You'll Do * Perform commissioning, qualification, and validation activities for Moderna's GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities. * Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met. * Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards. * Support new equipment qualification activities for capital and operational projects. * Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments. * Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.). * Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program. * Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs. * Drive results by owning and completing validation initiatives / projects against identified timelines. * Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities. * Additional duties as may be assigned from time to time Here's What You'll Need (Basic Qualifications) * B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master's degree in above discipline preferred. * Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments * Here's What You'll Bring to the Table (Preferred Qualifications) * Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE). * Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection. * Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. * Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. * Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager. * Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner. * A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. * At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. * Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs * A holistic approach to well-being, with access to fitness, mindfulness, and mental health support * Family planning benefits, including fertility, adoption, and surrogacy support * Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown * Savings and investment opportunities to help you plan for the future * Location-specific perks and extras The salary range for this role is $72,500.00 - $116,000.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 *

: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is seeking an experienced Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes. We are accepting applicants who will be able to travel remotely throughout to client sites in the United States. WORK LOCATION: Travel to client sites will be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit. Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE). Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements. Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements. Provide technical support for the product/process lifecycle and related activities. Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed. Provide support for improvement projects regarding processes and systems. Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable. Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration). Analyze and recommend improved technology to increase quality and efficiency. Provide technical analysis and support for new or improved process systems. Facilitate and schedule meetings with subject matter experts across the organization. Ensure compliance with cGMP, regulatory, and industry standards. QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education : Bachelor's degree in Engineering, Bio/Pharma Science, or a related technical field of study. Technical Experience : 4-7 years of related engineering and/or technical experience required. Experience with cGMP Manufacturing within an FDA-regulated manufacturing company. Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company. Knowledge of FDA regulations and guidance or applicable regulatory standards and practices. Proficient with MS Office suite, MS Project, Visio, and related electronic formats required to perform the respective job at a client. Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc. Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer. Experience with Fillers, Wave Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers. Knowledge, Skills, and Abilities : Excellent computer, verbal, and written communication skills. Innovative problem-solving skills and an integrated view of business/scientific issues. Accountable and responsible individual to perform as intended for clients. Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints. ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. -- VALIDATION ENGINEER POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures. Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities. Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments. Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers. QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education : Bachelor's degree in a related life science field. Technical Experience : 4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, and Abilities : Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description : A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. We are actively seeking qualified candidates to join our talent pipeline for future client engagements. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures. Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities. Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments. Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers. QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education : Bachelor's degree in a related life science field. Technical Experience : 4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, and Abilities : Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Mindful Quality is a growing consulting firm in the Biotechnology and Pharmaceutical industries. Mindful Quality specializes in cleaning validation, process development, project management, and regulatory guidance related to manufacturing quality assurance. The Cleaning Validation Engineer is responsible for cleaning process engineering and validation for our clients. The position will involve supporting cleaning cycle development, cleaning validation, and continuous cleaning monitoring in cGMP facilities. Ideal candidate has experience in cleaning validation including CIP, COP, and manual cleaning. The Role Assess client's cleaning validation documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices. Troubleshoot cleaning failures, develop, and optimize cleaning processes. Write, revise, and review cleaning related documents including Master Plans, Project Plans, Batch Records, Standard Operating Procedures, Forms, Protocol, Summary Reports, Forms, Risk Assessments, etc. Interact with team members and clients to create, review, and approve documentation per timeline. Plan and track project deliverables. This includes coordination with internal and external team members. Create, develop, edit, and maintain high-quality documentation following internal and client style guidelines, document standards, and templates, while ensuring that quality targets, timelines, and regulatory requirements are met. Create, manage, and help close out protocol exceptions and deviations Manage protocol execution paperwork as needed to support clients. Create and manage Change Control and CAPA documentation Look for ways to continuously improve generated documentation Communicate effectively with team members and external vendors/clients Develop training materials for manufacturing staff based on SOPs authored. Mentor and train client staff on cleaning validation principles Other duties as assigned by manager The Candidate Degree in Chemistry, Biochemistry, Pharmacy, Engineering, or other related fields 5+ years' experience in cleaning validation within a regulated manufacturing environment. Preferrable Pharmaceutical or Biotechnology industry. Working knowledge of GMPs - Preferred Hands-on experience with the following systems: CIP systems, parts washers, manual cleaning is required. Experience with rinse and swab sampling techniques Proven ability to review, interpret and make scientific conclusions and recommendations based on data Ability to understand and extract necessary information from technical documents 2-5 years of technical writing experience Excellent grammar and writing skills - Required Effectively work within a team environment and interface with peers, management, etc. Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals. - Required Able to effectively manage workload and prioritize activities Proficient computer skills Advanced knowledge of Microsoft Word/Excel/PowerPoint - Required Must be willing to travel to client sites worldwide to support work as needed.

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field * Knowledge and 8+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D

... Advanced Driver Assistance Systems (ADAS) Verification & Validation Application Engineer and focuses on ensuring the feature delivers the expectations of the customer. You will develop and implement feature requirements and specifications (including functional safety) for features like adaptive cruise control, automatic emergency braking, cross traffic alert, pro trailer features, advanced lighting, and 360 camera systems at a system and sub-system level and validate them according to the systems engineering model. As an Application Engineer, you will collaborate with research engineers, user experience teams, designers, hardware and software developers to define, develop, and verify the customer-facing attributes and performance capabilities of ADAS features. You will also develop new verification methods and work with vehicle, hardware-in-the-loop, model-in-the-loop and other advanced testing methodologies to validate your feature. You'll have... • B.S. in Electrical Engineering, Mechanical Engineering, or related technical field Experience preferably in developing features in the Driver Assistance domain using radars, cameras, lidars, ultrasonic sensors and other related vehicle systems (body, electrical, chassis, powertrain) Familiarity with actuators and control systems Even better, you may have... Masters in Engineering (Electrical, Mechanical, Aerospace, Mechatronics, Software, Computer Science, AI, Systems Engineering, Product Development) or related technical field Experience applying Systems Engineering principles Experience with robotic verification and testing methods Troubleshooting experience with electromechanical systems Experience with differential GPS equipment Experience using typical automotive interfaces: CAN, CANFD, Autosar, Auto-Ethernet, etc. Experience using Vector CANape, CANalyzer and dSPACE Controls Desk or similar tools Experience with Matlab/Simulink Experience in verification techniques (design verification methods, vehicle data acquisition/analysis) Experience with virtual validation methods (HIL/MIL/SIL) Strong leadership skills, passion for quality, passion to improve customer satisfaction Good communications and project management skills Strong oral & written skills Ability to work both independently and take initiative when necessary Strong teamwork & interpersonal skills You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply! As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder…or all of the above? No matter what you choose, we offer a work life that works for you, including: • Immediate medical, dental, vision and prescription drug coverage • Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more • Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more • Vehicle discount program for employees and family members and management leases • Tuition assistance • Established and active employee resource groups • Paid time off for individual and team community service • A generous schedule of paid holidays, including the week between Christmas and New Year's Day • Paid time off and the option to purchase additional vacation time. This position is a range of salary grades 6-8 . For more information on salary and benefits, click here: ***************************** Visa sponsorship is not available for this position. Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Onsite work of up to four days per week will be required for candidates within commuting distance of a Ford hub location. #LI-Hybrid #LI-CL2 What you'll do... Define and document the vehicle-level acceptance criteria for ADAS features Lead / support the development of verification plans and verification methods Collaborate with global functional partners to meet system and vehicle level performance requirements Cascade system-level requirements to functional partners Lead/support the development and sign-off of ADAS features on vehicle programs Support feature calibration studies to satisfy vehicle-level performance requirements Develop MATLAB and CAN tools for data collection and analysis Identify opportunities to utilize HiL and CAE methods for feature calibration and performance verification Plan and execute real-world evaluations of ADAS features via vehicle/HIL/virtual testing and identify system problems and issues Support and coordinate root-cause analysis with internal functions and external suppliers to ensure delivered system achieves feature requirements Benchmark competitors and monitor public domain requirements

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: * Validation Specialist for Packaging Lines Equipment Periodic Review * Qualifications: * Bachelor's Degree in Science or Engineering. * Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Experience in commissioning, qualification and validation of packaging lines (Carton labeler, autoinjector labeler, buffer accumulator, Cartoner, case packer, palletizer, Systech Sentri vision systems) * Must be proficient using MS Windows and Microsoft Office applications. * Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. * Experience in Design Documentation (URS, DS), IQ, OQ, PQ, Periodic reviews protocols development and execution, deviations and reports generation. * SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). * Strong knowledge in Packaging equipment. * Technical Writing skills and investigations processes. * Available to work extended hours, possibility of weekends and holidays.

Remote - Payment Validation Analyst PFS Billing-Follow Up-Denials Full Time Status Day Shift Pay: $54,038.40 - $81,057.60 / hour Candidates residing in the following states will be considered for remote employment: Alabama, Colorado, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Minnesota, Missouri, Mississippi, Nebraska, North Carolina, Oklahoma, Texas, Utah, and Virginia. Remote work will not be permitted from any other state at this time. Responsible for ensuring accurate payment is received from payors, including line level payment validation where appropriate. This position works under the supervision of the Director of Revenue Integrity, and is employed by Mosaic Life Care. Responsible for analyzing contractual underpayments. Identify and resolve daily encounters holding in Epic WQs for contractual underpayments. Identify root cause and work on corrective action implementation. Responsible for resolving encounters in Epic WQ for price/contract discrepancy. Identify root cause and work with CDM Analyst/Revenue Integrity Analyst to implement fee schedule correction, and/or identify root cause causing the discrepancy. Works on rebill projects focused on recoupment of underpayments. Subject matter expert regarding payer reimbursements and contracts. Be informed of changes to payer reimbursement and work with CDM Analyst and/or Revenue Integrity Analysts to implement changes, if and as needed. Other duties as assigned Bachelor's Degree, and H.S. Diploma are both required. 5 Years of Health care experience. Minimum five years' experience and knowledge of hospital financial operations including reimbursement, Medical Billing, Charge Master Development and Maintenance, Medical Records/Coding and Charge Audit experience is required. 5 Years of Broad based knowledge of hospital financial operations including reimbursement, coding and charge master development and maintenance is required. 5 Years of In-depth knowledge of CPTs, HCPCs and ICD-10 medical coding, and related APC Medicare reimbursement is required. Epic Contracts Module Certification is preferred.

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit *********************************** About the Role: We are seeking a detail-oriented and compliance-focused Pharmaceutical Validation Engineer to support validation activities across sterile and non-sterile compounding operations in our 503A and 503B pharmacy facilities. The ideal candidate will be responsible for ensuring that all systems, equipment, processes, and environments perform reliably and consistently according to regulatory and operational standards. This role requires hands-on experience with commissioning and qualification (CQV), process and cleaning validation, and equipment/system lifecycle documentation in accordance with cGMP, USP , , , and FDA 21 CFR Part 210/211 standards. The candidate will collaborate cross-functionally with pharmacy operations, quality, engineering, and IT teams to maintain regulatory compliance and validation readiness. You Will: Validation Development & Execution * Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for cleanrooms, HVAC systems, compounding equipment, and critical support systems. * Create validation master plans, risk assessments (e.g., FMEA), traceability matrices, and standard protocol documentation. Validation Activities & Data Analysis * Perform validation testing including equipment calibration, challenge studies, and environmental monitoring qualification. * Analyze validation data to verify compliance and identify trends or deviations; recommend corrective actions and process improvements. Documentation & Regulatory Compliance * Prepare and maintain detailed validation reports, change control documentation, and CAPA records in compliance with cGMP and internal SOPs. * Support audits and inspections by maintaining audit-ready documentation and presenting technical validation data. Commissioning & Qualification (CQV) * Execute CQV for pharmaceutical equipment, utilities (e.g., purified water, steam, compressed air), and facility systems to ensure readiness for commercial use. * Review vendor documentation and FAT/SAT results to support qualification efforts by coordinating with various vendors on a day to day basis and attending vendor FATs. Process, Cleaning, and Computer System Validation * Conduct process validation for sterile and non-sterile compounding workflows, ensuring consistent performance within defined parameters. * Perform cleaning validation to demonstrate removal of active pharmaceutical ingredients and contaminants from compounding equipment. * Support computer system validation (CSV) activities to ensure electronic systems meet 21 CFR Part 11 compliance. Cross-functional Collaboration * Collaborate with engineering, QA/QC, manufacturing, and IT teams to integrate new systems, troubleshoot issues, and ensure compliant implementations. * Train pharmacy and operations staff on validated systems and procedures. Continuous Improvement * Participate in continuous improvement initiatives by evaluating validation gaps and identifying opportunities for process and documentation enhancements. * Support efforts to maintain and improve environmental controls, pressure differential systems, HEPA filtration, and sterility assurance. You Have: * Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical, Industrial, or related field) or a science-based discipline. * 5+ years of experience in validation, quality assurance, or regulated pharmaceutical manufacturing, preferably in compounding environments. * Working knowledge of USP , , , cGMP, and FDA 21 CFR Part 210/211 regulations. * Experience in creating, executing and documenting IQ/OQ/PQ protocols, risk assessments, and change control procedures. * Familiarity with validation of utilities, cleanrooms, automation systems, and computer systems used in manufacturing and compounding. * Proficiency in Microsoft Office Suite, AutoCAD, and documentation systems such as Veeva, MasterControl, or equivalent. * Strong analytical, organizational, and problem-solving skills with attention to technical accuracy and regulatory compliance. * Excellent written and verbal communication skills with the ability to interact across cross-functional teams. * Demonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems. * Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams. * Strong written and verbal communication skills, including proficiency with Microsoft Office tools (Excel, Word, PowerPoint); experience with Smartsheet, Jira, or similar platforms is a bonus. * Willingness to travel as required to equipment FATs, vendor sites etc. Our Benefits (there are more but here are some highlights): * Competitive salary & equity compensation for full-time roles * Unlimited PTO, company holidays, and quarterly mental health days * Comprehensive health benefits including medical, dental & vision, and parental leave * Employee Stock Purchase Program (ESPP) * 401k benefits with employer matching contribution * Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. 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. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

Business Unit: Ops Digital Technology Innovation Employment Type: Contract Duration: 6+ months with likely extension Rate: $35-40/Hr on W2 with benefits Target start date : 4/28/25 Notes: Onsite New Albany, OH - must be local. Standard hours. 3 Key Consulting is hiring! We are recruiting a CSV Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company. The ideal candidate: 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. They must hold a Bachelor's or master's degree in computer science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field, with a Master's degree acceptable only if accompanied by at least 3 years of industry experience (no fresh graduates). The role requires onsite work with limited training time, so candidates must be able to hit the ground running. Overqualified candidates (e.g., PhDs or those with 15+ years of experience) may not be the best fit. Strong preference will be given to candidates from a pharmaceutical, biotechnology, or life sciences background. Job Description: Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client's Ohio computer systems validation. Top Must Have Skill Sets: Experience with testing tools (ALM, or Kneat or ValGenesis). Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. Understanding of industry standards and best practices for computer system validation such as GAMP 5. Must have experience with deviations IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery) Day to Day Responsibilities: Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies. Provide support on completion of validation deliverables as required per the project. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase. Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards. Support regulatory inspections and internal audits as required. Basic Qualifications: Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience 2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems). Experience with ALM or Kneat testing tool is plus. 2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management. 3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. 4. Understanding of industry standards and best practices for computer system validation such as GAMP 5. Why is the Position Open? Supplement additional workload on team. Red Flags: No experience on Computer system validation/ validation process. No experience on Deviations. Fresh graduates with no validation or industry experience. Lack of experience with computer system validation or deviation management. No background in Pharma, Biotech, Life Sciences, or relevant IT/Validation roles. Candidates switching from unrelated industries (since training time is limited). Overqualified candidates with 15-20+ years of experience and/or candidates with PhDs. Interview Process: WebEx or onsite. Interview rounds: Typically 2 rounds (with hiring manager and his manager), but could extend to 3 rounds if needed We invite qualified candidates to send your resume to *****************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team