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Validation Engineer remote jobs

- 310 jobs
  • Air Quality Engineer

    Trinity Consultants 4.5company rating

    Remote job

    About Us Trinity's core values represent an assurance of quality, professionalism, and reliability. To us, they are the foundation of our company, the standards against which we constantly judge ourselves. We are focused on client satisfaction, employee growth, and quality assurance. Trinity Consultants is committed to achieving optimal performance with minimal adverse environmental and societal impacts. Trinity is committed to the health and safety of our employees and the protection of the environment. Effective Health, Safety, and Environmental (HSE) protection in our business is every employee's responsibility for every activity that is conducted in our workplace or while at client facilities. ESSENTIAL DUTIES AND RESPONSIBILITIES Prepare air permit applications, for client projects in accordance with applicable local, state, and/or federal agency air regulations or standards. Perform emission calculations. Review and evaluate state and federal regulation applicability. Prepare, review, and submit regulatory reports and routine compliance reports as required by permits and applicable regulations. Review and analyze results of emissions testing. Knowledge or experience with air dispersion modeling. Assist clients with permitting strategy and developing pathways to continuous compliance. Communicate with clients and regulators as appropriate. Support preparation of proposals. Qualifications: Bachelor's, Master's, or other advanced degree in Environmental/Chemical/Civil Engineering. Minimum 2 years of experience in environmental consulting, focused on air quality. Advanced working knowledge of Excel and an understanding of the Windows operating system and Microsoft Office 365. Demonstrated understanding of state and federal air quality regulations and specific knowledge of general air permitting process: NSR, Title V, PSD, NSPS, NESHAP, BACT, etc. Excellent written and verbal communication skills and ability to coordinate and work effectively in a team setting. Ability to work independently in a remote work situation when needed. Excellent attention to detail and completeness. Must be able to perform multiple tasks with firm deadlines, sometimes deadlines could be simultaneous. (The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria necessary to successfully perform the job.) SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.
    $61k-78k yearly est. 4d ago
  • Field Validation Specialist - West BU

    Biomat USA, Inc. 4.2company rating

    Remote job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is a remote position with up to 75% travel for Candidates on the West Coast of the United States.** **Summary:** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing. **Primary Responsibilities:** + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations. + Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. + Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries. + Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Writes test cases to validate critical control points, user requirements, and functional designs. + Executes test cases as needed. + Prepares validation reports for distribution. + Ensures milestones and timelines are met on assigned projects. + Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: + Prepares validation equipment for use at the Donor Center and for evaluation upon return. + Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. + Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. + Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. + Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable. + Travels on-site up to 75% as needed to ensure timely validation completion within the Geo. **Knowledge, Skills, and Abilities:** + Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. + Excellent quantitative and analytical skills. + Excellent oral and written communication skills. + Strong critical thinking and problem solving skills. + Ability to identify errors and provide corrective action. + Ability to work with others in a team environment. + Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. **Education and Experience:** + Bachelor's degree. + Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. + Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands:** Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 537057 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $69.4k-104.1k yearly 25d ago
  • Field Validation Specialist - West BU

    Grifols Sa 4.2company rating

    Remote job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This is a remote position with up to 75% travel for Candidates on the West Coast of the United States. Summary: Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing. Primary Responsibilities: * Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: * Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations. * Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. * Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries. * Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. * Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: * Writes test cases to validate critical control points, user requirements, and functional designs. * Executes test cases as needed. * Prepares validation reports for distribution. * Ensures milestones and timelines are met on assigned projects. * Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: * Prepares validation equipment for use at the Donor Center and for evaluation upon return. * Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. * Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. * Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. * Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable. * Travels on-site up to 75% as needed to ensure timely validation completion within the Geo. Knowledge, Skills, and Abilities: * Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. * Excellent quantitative and analytical skills. * Excellent oral and written communication skills. * Strong critical thinking and problem solving skills. * Ability to identify errors and provide corrective action. * Ability to work with others in a team environment. * Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. Education and Experience: * Bachelor's degree. * Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : Home Office:[[cust_building]]
    $69.4k-104.1k yearly 24d ago
  • Lead Validation Specialist

    Theradex Oncology 4.1company rating

    Remote job

    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.
    $125k-150k yearly Auto-Apply 22d ago
  • DRG Validation Specialist

    Maine Health 4.4company rating

    Remote job

    MaineHealth Corporate Professional - Clinical MaineHealth is actively recruiting for a DRG Validation Specialist. This is a 100% remote opportunity. The DRG Validation Specialist job functions will include: * reviews codes to validate DRG assignment * appeals external audits * processes Cloudmed recommendations * resolves DRG matches between CDI and coding * answers coding questions * identifies opportunities for query composition improvement/compliance * identifies educational needs * creates educational materials Required Minimum Knowledge, Skills, and Abilities (KSAs) * Education: Associate's and/or Bachelor's Degree in Health Information Management or other science based degree such as Nursing required. * License/Certifications: Registered Health Information Technician (RHIT), Registered Health Information Administrator (RHIA), or Certified Coding Specialist (CCS) required. * Experience: Three years of experience as an inpatient coder at a large acute care or academic teaching facility required. * Additional Skills/Requirements Required: N/A * Additional Skills/Requirements Preferred: Advanced coding skills and knowledge of revenue cycle, billing systems, EPIC Electronic Health Record and 3M Encoder, ICD 10 training, Computer Assisted Coding software (CAC) In addition to the KSA's above, the successful candidate should also have the following skill sets: * Auditing experience * Strong oral and written communication skills * Critical thinking and strong organizational skills Additional Information With a career at any of the MaineHealth locations across Maine and New Hampshire, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the communities that surround it. We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.
    $86k-105k yearly est. 38d ago
  • Compliance Validation Specialist - Part Time & Remote

    Testpros

    Remote job

    TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST SP 800-171 Assessment and Compliance, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer. TestPros delivers innovative independent IT assessment solutions to critical challenges facing the nation and the world. We support the U.S. Federal Government and Commercial clients within the continental USA. TestPros is dedicated to making lives better, safer and more secure. Job Summary TestPros is seeking a qualified consultant to ensure its websites and mobile applications comply with Web Content Accessibility Guidelines (WCAG) 2.1 Level AA standards as mandated by the U.S. Department of Justice's (DOJ) 2024 final rule under Title II of the Americans with Disabilities Act (ADA). This project aims to improve digital accessibility for individuals with disabilities and align the digital platforms with federal accessibility requirements. Position: Part time (as needed, 1099 or Corp. to Corp) Citizenship: U.S. Citizenship or Green card holder Location: Remote Clearance: None Responsibilities: Re-assess websites and mobile applications post-remediation to confirm WCAG 2.1 compliance. Conduct certification or validation processes for accessibility standards. Deliver final compliance reports, documenting validation results. Qualifications: Expertise in evaluating web and mobile platforms against WCAG 2.1 AA requirements. Familiarity with compliance certification processes. Strong attention to detail and thorough understanding of accessibility testing methods. Proven ability to work with regulatory standards and certifications. Benefits TestPros offers a competitive salary, medical/dental/vision insurance, life insurance, paid time off, paid holidays, 401(k) retirement plan with company match, opportunities for professional growth, cell phone discounts, and much more! All benefits are per TestPros current policies and are subject to change without notice. Benefits are available to full-time employees. TestPros, Inc. is an Equal Opportunity Employer. EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, protected veteran status, or disability. VEVRAA Federal Contractor.
    $77k-104k yearly est. Auto-Apply 60d+ ago
  • Validation Engineer with DDR Familiarity

    Qualcomm 4.5company rating

    Remote job

    Company: Qualcomm Technologies, Inc. Job Area: Engineering Group, Engineering Group > ASICS Engineering As a leading technology innovator, Qualcomm pushes the boundaries of what's possible to enable next-generation experiences and drives communication and data processing transformation to help create a smarter, connected future for all. Qualcomm's Silicon Validation team is part of the central SoC digital hardware organization responsible for the overall quality of the SoC silicon. The validation team works closely with architects, designers, verification engineers, software engineers, and customers. The team is currently seeking candidates specifically in SOC validation in pre-silicon emulation and post-silicon regression. Technical disciplines, languages and methodologies included in this team are: * DDR related debug * Regression and PVT testing * Emulation Build Validation, * Post-Si Regressions Required Qualifications: * Intelligent and high potential of learning new topics. * Familiarity with DDR interface, JEDEC spec, bus level view of transactions * Need experience with Memory Analyzer, Logic Analyzer, DDR trace decoding and post processing. * Familiar with RDIMM, LRDIMM, HBM3, HBM4, CXL, DDR5, DDR6 * Regression and PVT testing * Emulation Build Validation * Potency in reading C code, understanding code flow, code manipulation, and test iteration. * Post-Si test execution and data review * Familiarity with logic design * Proven track record of hardware debug. * hands-on experience of debugging low level software and hardware issues * Debug tools including JTAG and kernel debuggers * Lauterbach experience preferred. Minimum Qualifications: * Bachelor's degree in Science, Engineering, or related field and 4+ years of ASIC design, verification, validation, integration, or related work experience. OR Master's degree in Science, Engineering, or related field and 3+ years of ASIC design, verification, validation, integration, or related work experience. OR PhD in Science, Engineering, or related field and 2+ years of ASIC design, verification, validation, integration, or related work experience. Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail disability-accomodations@qualcomm.com or call Qualcomm's toll-free number found here. Upon request, Qualcomm will provide reasonable accommodations to support individuals with disabilities to be able participate in the hiring process. Qualcomm is also committed to making our workplace accessible for individuals with disabilities. (Keep in mind that this email address is used to provide reasonable accommodations for individuals with disabilities. We will not respond here to requests for updates on applications or resume inquiries). To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Qualcomm. Staffing and recruiting agencies and individuals being represented by an agency are not authorized to use this site or to submit profiles, applications or resumes, and any such submissions will be considered unsolicited. Qualcomm does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. EEO Employer: Qualcomm is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or any other protected classification. Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. Pay range and Other Compensation & Benefits: $140,000.00 - $210,000.00 The above pay scale reflects the broad, minimum to maximum, pay scale for this job code for the location for which it has been posted. Even more importantly, please note that salary is only one component of total compensation at Qualcomm. We also offer a competitive annual discretionary bonus program and opportunity for annual RSU grants (employees on sales-incentive plans are not eligible for our annual bonus). In addition, our highly competitive benefits package is designed to support your success at work, at home, and at play. Your recruiter will be happy to discuss all that Qualcomm has to offer - and you can review more details about our US benefits at this link. If you would like more information about this role, please contact Qualcomm Careers.
    $140k-210k yearly 60d+ ago
  • Coding Validator Telecommute IP

    Brown University Health 4.6company rating

    Remote job

    SUMMARY: Ensures accurate coding and data quality, creating consistency and efficiency in inpatient and/or outpatient services through ongoing performance of ICD-10-CM and/or CPT coding validation and accurate MS DRG, APR DRG and/or outpatient APC. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate RESPONSIBILITIES: Performs coding quality reviews on inpatient records to validate the ICD-10-CM codes, DRG group appropriateness, missed secondary diagnoses and procedures, and ensures compliance with all DRG mandates and reporting requirements. Ensures validity of data prior submission of bill. Performs retrospective coding audits as required. Performs data quality reviews on outpatient encounters to validate the ICD-10-CM, CPT and HPCS Level II codes, modifier assignments, APC group appropriateness, missed secondary diagnosis and procedures and ensure compliance with all outpatient coding mandates. Ensures medical necessity criteria is met and local medical review polices are followed. Continuously evaluates the quality of the clinical documentation to spot incomplete or inconsistent documentation for inpatient encounters that impact code selection and resulting DRG groups and payments. Brings identified concerns to department manager for resolution. Provides training for coding staff and educates facility healthcare professionals in the use of coding guidelines and practices, proper documentation techniques, medical terminology and disease processes as it relates to the MS DRG, APR DRG and/or outpatient APC and other clinical data quality management. Maintains knowledge of current professional coding certification requirements. Reviews LifeChart coding validator, coding error and CED work queues. Identifies any coding or coding related charge issues to leadership. Performs routine coding validation audits. Prepares reports for director on coder accuracy results. Abides by the Standards of Ethical Coding as set forth by the American Health Information Management Association and monitors coding staff for violations and reports to Coding Manager when areas of concern are identified. Provides direction to coding staff in absence of management. MINIMUM QUALIFICATIONS: BASIC KNOWLEDGE: Associate degree in health information technology (preferably with RHIT) and/or successful completion of coding certification program. Understanding of the content of the medical record. Trained in medical terminology, medical science, disease processes anatomy and physiology. Ability to recognize and understand clinical documentation pertinent for coding. Good writing skills to prepare compliant physician queries. Computer literate; capable of researching websites to access regulatory requirements. Ability to navigate the patient electronic medical record. Coding specialist certification required. EXPERIENCE: Five years coding optimization experience in an acute care facility. Past auditing experience or strong training background in coding preferred. WORKING CONDITIONS AND PHYSICAL REQUIREMENTS: After orientation at the hospital's facilities, work is performed at the employee's residence in accordance with provisions of a telecommuting work agreement, to which the employee has agreed as a condition of working in an off-campus location. The hospital's normal office and central work location environment applies for assignments, meetings, and other requirements as determined by department management. INDEPENDENT ACTION: Performs independently within the department's policies and procedures. Refers specific complex problems to the supervisor when clarification of the departmental policies and procedures are required. SUPERVISORY RESPONSIBILITY: None. Pay Range: $30.39-$50.16 EEO Statement: Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, ethnicity, sexual orientation, ancestry, genetics, gender identity or expression, disability, protected veteran, or marital status. Brown University Health is a VEVRAA Federal Contractor. Location: Corporate Headquarters - 167 Point Street Providence, Rhode Island 02903 Work Type: PER DIEM-FLex Work Shift: Variable Daily Hours: Per Diem - As required Driving Required: No
    $30.4-50.2 hourly 3d ago
  • FMS Verification & Validation Engineer- Aerospace Industry

    DBSI Services 3.5company rating

    Remote job

    Benefits: 401(k) 401(k) matching FMS Verification & Validation Engineer Only USC/ GC About the Role: We are seeking a skilled Verification Engineer with expertise in Flight Management Systems (FMS). The ideal candidate will have experience in verification and validation (V&V) processes for avionics systems, with a strong background in display, navigation, and application systems within FMS. Skill Matrix: · Yrs. In Flight Management Systems · Yrs. In verification and validation · Yrs. In Display, GPS/Navigation systems · Yrs. In DO-178C · Yrs. In SSIT and HSIT level testing · Yrs. In Aerospace · Yrs. In DOORs or JAMA · Yrs. In Flight Deck Avionics Systems. Qualifications You Must Have · Must possess at least a bachelor's degree or its equivalent in Aerospace Engineering, Systems Engineering, Electrical Engineering, Computer Engineering, Software Engineering, Industrial Engineering or a related field and at least five years of progressive experience as a Software Engineer or related role in the avionics industry. In the alternative, at least a master's degree or its equivalent in Aerospace Engineering, Systems Engineering, Electrical Engineering, Computer Engineering, Software Engineering, Industrial Engineering or a related field and at least three years of experience as a Software Engineer or related role in the avionics industry would be acceptable. · Must possess at least 3 years of experience with development, verification, and certification of Real time embedded Software and/or Flight Deck Avionics Systems. · Must possess at least 3 years of experience with capturing requirements in a requirements management tool, such as DOORs or JAMA. · Must possess at least 3 years of experience with following processes and standards related to the development of software (such as DO-178). · Must possess at least 3 years of experience working closely with multi-disciplinary engineering teams. What You will do · Conduct and coordinate moderately complex tests for control and diagnostic systems that contain logical and mathematical solutions. · Conduct multidisciplinary research in assisting equipment designers in the planning, design, development, and utilization of electronic data processing systems for product and commercial software to develop software engineering activities. · Analyze system capabilities and determines end user needs to resolve problems on program intent, output requirements and input data acquisition to ensure current and future needs of the business are met. · Ensure hardware and software standards are met. · Design and implement build procedures that are used to support hardware and software product development and use. · Develop software configuration standards for company-wide use. This is a remote position. Compensation: $110,000.00 - $120,000.00 per year MAKING THE INDUSTRY'S BEST MATCHES DBSI Services is widely recognized as one of the industry's fastest growing staffing agencies. Thanks to our longstanding experience in various industries, we have the capacity to build meaningful, long-lasting relationships with all our clients. Our success is a result of our commitment to the best people, the best solutions and the best results. Our Story: Founded in 1995 Privately Owned Corporation Managing Partner Business Model Headquartered in New Jersey US Based Engineers Only Collaborative Team Approach Methodology and Process Driven GET HIRED Top performing engineers are the foundation of our business. Our priority is building strong relationships with each employment candidate we work with. You can trust our professional recruiters to invest the time required to fully understand your skills, explore your professional goals and help you find the right career opportunities.
    $110k-120k yearly Auto-Apply 60d+ ago
  • Engineer II, Validation

    Moderna Theraputics

    Remote job

    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 *
    $72.5k-116k yearly Auto-Apply 42d ago
  • Staff Silicon Validation Engineer

    Latticesemi

    Remote job

    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… 5+ years of experience Electrical Engineering degree with a strong desire to pursue an engineering career in Silicon Design Validation 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. Who Are We? At Lattice, we are good at collaboration and problem solving. We're also good at having a bit of fun. We develop technologies that we monetize through differentiated programmable logic semiconductor products, system solutions, design services and licenses. We are the low power programmable leader. We solve customer problems across the network, from the Edge to the Cloud, in growing communications, computing, industrial, automotive and consumer markets. Our technology, long-standing relationships and commitment to world-class support enable our customers to create a smart, secure, and connected world. Join Team Lattice…and help us continue to drive innovation that creates a smarter, better-connected world. Together, we enable what's next.
    $71k-94k yearly est. Auto-Apply 15h ago
  • Validation Engineer (Python/Post Silicon/CPU/Linux)

    Nutanix 4.7company rating

    Remote job

    **Hungry, Humble, Honest, with Heart** **The Opportunity** Are you passionate about advanced compute and platform technologies that will power the software infrastructure and server workloads of tomorrow? Do you have strong technical acumen, excellent programming skills, and a deep interest in open-source and Linux? If so, Nutanix's CPU Enablement Engineer role might be an ideal fit for you. Join our pioneering Core Platform Software team within Platforms Engineering working on enabling the latest CPUs and platform compute technologies. As a top candidate, you'll have the opportunity to take on the challenges of software support for complex, next-gen compute technologies, and you'll help build the foundation for modern, hardware-accelerated cloud computing infrastructure. Don't miss out on this chance to be part of a dynamic, impactful team that encourages innovation and learning. **About the team** Nutanix Cloud Infrastructure is designed to enable the broadest range of virtualized server workloads to run on widely available server hardware, utilizing direct attached flash drives to provide scale-out storage, and integrated with compute and networking services. Customers can choose from multiple hypervisors options, including our own increasingly popular open-source based Acropolis Hypervisor (AHV), to utilize the latest CPU and platform technologies. The rapid development of advanced CPU and memory technologies - as well as the rising prominence of compute-intensive workloads in the datacenter - provide Nutanix with unprecedented engineering challenges and opportunities for product innovation. What's unique about our Core Platform Software CPU enablement team at Nutanix is that we are on the cutting edge of the latest CPU and platform technologies from the industry leading vendors. We engage in new technology and open-source analysis far in advance of new CPU launches, and we get hands-on access to very early equipment to engineer software support for the latest compute technologies. We also interact closely with other Nutanix engineering teams and collaborate on software layers across our stack. **Your Role** + Collaborate with cross functional teams (Acropolis OS, AHV, Foundation, etc.) to enable new CPU and new compute technologies for the Nutanix core product stack. + Technical analysis of new processor and CPU platform technologies including CPU, memory and PCIe as well as integrated CPU accelerators. + Develop and maintain software that monitors and governs hardware platform functionality, including power state management, memory RAS, PCIe error handling, and support for predictive failure indicators. + Evaluate and integrate upstream Linux kernel patches and system utilities to support new CPU generations. + Perform early hypervisor software bring-up on CPU simulators, prototype platforms, and pre-production systems from server vendor partners. + Build tooling for CPU performance counters, memory bandwidth utilization, NUMA performance, and PCIe bus utilization. + Ensure broad compatibility of Nutanix AHV hypervisor with industry standard server platforms. + Drive reliability and performance improvements in the Nutanix software stack through Linux kernel advancements, OS/hypervisor tuning, and BIOS optimizations. + Design and implement test strategies, test plans, and test frameworks hypervisor interoperability with next generation CPUs using agile methodologies. + Debug and resolve customer reported issues related to CPU and platform technologies. **What You Will Bring** + Bachelors/Masters in Computer Science, Computer Engineering, or a related field with 3-6 years of experience in a product focused environment. + Deep understanding of Intel/AMD x86 platform architecture and operating systems internals, especially the Linux OS. + Hands-on experience with Linux kernel development and device drivers for I/O subsystems. + Familiarity with open source hardware support and system level performance characterization. + Experience with virtualization technologies such as VMware ESXi, KVM/QEMU and container runtimes + Strong programming skills in Python, Go, Rust, C/C++ for tooling and automation. + Experience with core software development, including + Building scalable and maintainable systems software + Developing automation frameworks for testing and deployment + Working with databases for telemetry, logging and performance analysis + Knowledge of performance profiling tools like perf and familiarity with CPU microarchitecture features (e.g. cache hierarchy, branch prediction, SMT). + Strong analytical and debugging skills, with a passion for solving complex system-level problems + Excellent written and verbal communication skills,with a collaborative mindset. The pay range for this position at commencement of employment is expected to be between USD $ 128000 and USD $ 255,600 per year. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Our application deadline is 40 days from the date of posting. In good faith, the posting may be removed prior to this date if the position is filled or extended in good faith. Hybrid: This role operates in a hybrid capacity, blending the benefits of remote work with the advantages of in-person collaboration. In locations where our workplace policy applies (i.e. San Jose, Durham, Mexico City, Bangalore, Pune, Hoofddorp, Belgrade, Barcelona, Singapore, Sydney and Tokyo), employees are expected to work onsite a minimum of 3 days per week to foster collaboration, team alignment, and access to in-office resources. Workplace type may vary based on location and team requirements. Please speak with your recruiter for details. Additional team-specific guidance and norms will be provided by your manager. We're an Equal Opportunity Employer Nutanix is an Equal Employment Opportunity and (in the U.S.) an Affirmative Action employer. Qualified applicants are considered for employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, protected veteran status, disability status or any other category protected by applicable law. We hire and promote individuals solely on the basis of qualifications for the job to be filled. We strive to foster an inclusive working environment that enables all our Nutants to be themselves and to do great work in a safe and welcoming environment, free of unlawful discrimination, intimidation or harassment. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you need a reasonable accommodation, please let us know by contacting CandidateAccommodationRequests@nutanix.com.
    $128k-255.6k yearly 18d ago
  • Process Validation Engineer, Expert

    Agilent Technologies, Inc. 4.8company rating

    Remote job

    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
    $105.3k-164.5k yearly Auto-Apply 33d ago
  • Validation Engineer

    Syner-G Biopharma Group

    Remote job

    : 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.
    $88k-104k yearly Auto-Apply 2d ago
  • Validation Engineer

    Syner-G

    Remote job

    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.
    $88k-104k yearly 14d ago
  • Model Validation Analyst

    United Community Bank 4.5company rating

    Remote job

    United Community is seeking a Model Validation Analyst to conduct independent validations of various models in compliance with SR 11-7. This role supports the annual risk assessment process, maintains the model inventory, assists in planning validation schedules, and prepares model risk-related reporting. The analyst will collaborate with model stakeholders and provide effective challenge throughout the model lifecycle. What You'll Do * Perform Independent Validations: Validate models across credit risk, valuation, ALM, fraud, BSA/AML, operations, and marketing. * Collaborate with Stakeholders: Engage with model owners and developers to assess risk and provide effective challenge. * Support Risk Assessment: Assist in annual risk assessments and validation scheduling. * Maintain Model Inventory: Update inventory and track validation findings. * Prepare Reports: Document validation results and communicate findings to management and governance committees. * Monitor Performance: Conduct model evaluations and performance reviews. * Ensure Compliance: Apply regulatory guidance (SR 11-7, OCC Bulletin 2011-12) during validations. * Research & Improve: Stay current on modeling best practices and validation techniques. Requirements For Success Required Skills/Experience/Education: * Bachelor's degree in Statistics, Econometrics, Economics, Mathematics, or related quantitative field (Advanced degree preferred). * Minimum 5 years of relevant experience in model risk management, financial modeling, or quantitative analysis. * Strong quantitative and analytical skills with a critical mindset. * Proficiency in Python (advanced), R, MATLAB, or SQL. * Knowledge of risk modeling practices and regulatory requirements (SR 11-7, OCC Bulletin 2011-12). * Excellent verbal and written communication skills. Preferred Skills/Experience/Education: * Advanced degree or certifications in quantitative disciplines. * Experience with machine learning and advanced statistical modeling. Supervisory Responsibility May supervise certain validation activities and mentor junior analysts. May manage validation-related projects. Working Environment & Physical Demands * Professional office environment; standard office equipment usage. * Sedentary work with occasional standing, stooping, and typing. * Schedule flexibility for evenings/weekends as needed. * Up to 20% travel required. Conditions of Employment * Must be able to pass a criminal background & credit check * This is a full-time, non-remote position FLSA Status: * Exempt We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Pay Range USD $60,466.00 - USD $93,119.00 /Yr.
    $60.5k-93.1k yearly 28d ago
  • Sr. Navy Qualified Validator ( NQV) Philadelphia, PA

    Watershed Security

    Remote job

    Watershed Security, is a Veteran Owned Small Business with over 20 years' Cybersecurity and Government Contracting experiencing. Watershed is looking for a Senior Navy Qualified Validator (NQV) to support the Naval Surface Warfare Center (NSWC) in Philadelphia, PA. The successful candidates will be responsible for reviewing and implementing Risk Management Framework (RMF) lifecycle documentation, ensuring the confidentiality, integrity, and availability (CIA) of systems, networks, and information. This position involves conducting risk and vulnerability assessments, ensuring proper accreditation procedures are followed, and documenting any non-compliance issues. REQUIRED QUALIFICATIONS Bachelor's degree in computer science, information technology, communications systems management, or an equivalent science, technology, engineering & mathematics (STEM) degree from an accredited college or university. Active Navy Qualified Validator Certification. Must have at least one of the following active certifications: CCNA Security, CySA+, GICPS, GSEC, Security+, CND, SSCP. Years of Experience: Ten (10) years' practical experience in a cybersecurity or A&A related field. Implementing and/or reviewing RMF lifecycle documentation Validating confidentiality, integrity, and availability of systems Conducting risk and vulnerability assessments Ensuring proper accreditation procedures are followed Documenting non-compliance issues Clearance Level: SECRET; US Citizen. Ability to possibly provide onsite support in Philadelphia PA. Some/all remote work may be an option, however the norm will be onsite support. This will be dependent upon customer needs and classification level of work being performed. Some travel may be required. Experience with the Navy RMF Process Guide (RPG), and Navy A&A tools such as ACAS, eMASS and eMASSter. Proficient with Microsoft Office Suite (Word, Excel, Teams, Project). Self Starter; detail oriented; able to brief senior level staff. DESIRED QUALIFICATIONS Validation of 10 or more Navy Packages Experience with the NAVSEA RMF Business Rules Contingent upon award PAY RANGE Final salary is influenced by factors such as location, contract labor categories, experience, skills, education, and certifications. Watershed offers competitive compensation, medical and dental benefits, educational reimbursement, 401K plans with matching, 15 days of PTO to start and 11 paid holidays per year. The proposed salary range for this position is: $100,000 - $130,000 USD. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
    $100k-130k yearly Auto-Apply 60d+ ago
  • Senior Battery Validation Engineer

    Ford Global

    Remote job

    We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than ourselves. Are you ready to change the way the world moves? Ford's Electric Vehicles, Digital and Design (EVDD) team is charged with delivering the company's vision of a fully electric transportation future. EVDD is customer-obsessed, entrepreneurial, and data-driven and is dedicated to delivering industry-leading customer experience for electric vehicle buyers and owners. You'll join an agile team of doers pioneering our EV future by working collaboratively, staying focused on only what matters, and delivering excellence day in and day out. Join us to make positive change by helping build a better world where every person is free to move and pursue their dreams. In this position... The Battery Validation Engineer will be responsible for enabling innovation through quick testing and characterization of battery components and systems. This individual will define test plans, execute them safely, and report results in order to successfully validate Ford's next generation of EV batteries. You'll have… Bachelor's degree in engineering or related field 5+ years of experience in battery testing and validation Experience with battery test equipment, instrumentation, and data acquisition systems Knowledge of battery chemistry, physics, and safety standards Ability to work independently and collaboratively in a fast-paced environment Strong problem-solving, communication, and project management skills Knowledge of statistical analysis and design-of-experiment Experience in test fixture design and fabrication; 3-D CAD experience preferred Experience in structural, electrical, thermal, and mechanical systems Familiarity with US and international battery safety requirements/regulations Hands-on experience in HV battery system abuse testing Ability to travel to external test labs as needed Even better, you may have… Master's degree in engineering Hands-on experience building and launching automotive products Experience in configuration, development and maintenance of automated test systems Strong written and verbal communication skills Experience using Confluence, Jira, Jama, or other project management tools An eagerness to work cross-functionally in a dynamic environment where you are part of a high performing team A system approach to design and development with the desire and curiosity to strive for exceptional delivery execution and continuous improvement 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 salary grade 8. For more information on salary and benefits, click here: ***************************** This position is a range of salary grades 5-8 . Visa sponsorship is 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. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call **************. Onsite work of up to four days per week may be required for candidates within commuting distance of a Ford hub location. #LI-Hybrid #LI-HA1 What you'll do... Plan, coordinate, and execute battery pack validation tests covering various categories including performance, durability, and abuse Author test scripts for equipment including cyclers, chambers, chillers, and DAQ systems Own data storage and visualization Analyze test data and generate test reports, evaluating compliance with requirements and identifying issues or opportunities for improvement Work alongside systems engineers to define requirements Work alongside cell engineers to define test profiles and correlate cell and pack results Work alongside prototyping and logistics teams to coordinate sample assembly and delivery Work cross-functionally across engineering, manufacturing, quality, and service to communicate test results and provide feedback on battery design and integration Assist battery part owners to develop component-level tests Setup data acquisition systems and specialized measurement equipment as needed Work with fabrication team as needed to design and build custom fixtures Manage external vendors and partners for additional testing capabilities
    $91k-122k yearly est. Auto-Apply 60d+ ago
  • Senior Validation Engineer, Biotech - Hybrid (JP11465)

    3 Key Consulting

    Remote job

    Employment Type: Contract to Hire Business Unit: Business and Operations Management Duration: Initial 3 months with likely extension(s). Posting Date: 05/22/2023. Rate: $50-58 / Hour plus benefits. Note: Onsite 2-3 times a week 3 Key Consulting is hiring a Senior Validation Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Primarily responsible for ensuring adherence to computer validations, data integrity standards, and procedures for computer related analytical laboratory instruments. 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 department, IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in issue resolution during installation and qualification activities. Ability to effectively communicate and multitask. Has knowledge of commonly used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job; possess the ability to effectively communicate and multitask. Works under immediate supervision with the ability to work independently and as a team. Top 3 Must Have Skill Sets: Experience with qualifying analytical laboratory computer instrumentation systems. Validation actions including but not limited to leading, developing and implementing strategies and authoring required COTS Validation documents. (LCMS, FTIRs, Titrators etc.) Knowledge of cGMPs, ALOCA+, Data Integrity requirements (21 CFR Part 210/211, Part 11) and Analytical Instrument Qualifications (USP 1058). Team player and independent working with excellent communication Responsibilities: Implement and coordinate the installation and qualification of laboratory equipment and computer systems (hardware, software, and accessory systems etc.) for use in regulated operations. Author qualification of CSV documents through system life cycle as outlined in applicable SOPs. This includes deliverables such as user requirements, functional/design specifications, qualification protocols, testing summary reporting, and support documentation (traceability matrices, deviations, SOP, etc.). Manage documentation from creation to approval. Review laboratory requirements and define procedures for instrument and data management/data integrity for new instrumentation. Implement 21 CFR Part 11 for new and existing equipment, testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with company standards and cGMP requirements. Support installation and re-qualification activities when needed to ensure proper systems startup, troubleshooting during use and recommend changes to improve application software's system design. Work collaboratively across functions including Quality, IS, vendors and scientific lab staff. Red Flags: Unclear communication. Unfamiliar with analytical instruments. Unfamiliar with data integrity/21CFR Part 11 requirements. Interview process: 1 WebEx Interview We invite qualified candidates to send your resume to *****************************. If you decide that you're not interested in pursuing this position, please feel free to take a look at the other positions on our website ******************************* You are welcome to also share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team
    $50-58 hourly Easy Apply 60d+ ago
  • 3.20 Verification and Validation Software Engineer

    Field Ai

    Remote job

    Who are We? Field AI is transforming how robots interact with the real world. We are building risk-aware, reliable, and field-ready AI systems that address the most complex challenges in robotics, unlocking the full potential of embodied intelligence. We go beyond typical data-driven approaches or pure transformer-based architectures, and are charting a new course, with already-globally-deployed solutions delivering real-world results and rapidly improving models through real-field applications. Learn more at ******************** About the Job We are looking for a Verification and Validation Software Engineer to own the quality bar for Field AI's off-road autonomy, legged, and humanoid robotics stacks-designing strategy, building tooling, and shipping the evidence that proves we're safe and ready for the real world. You'll implement scalable scenario-based testing (SIL/HIL + high-fidelity simulation), stand up CI pipelines and metrics that catch regressions early, and lead structured field validations where the terrain is messy and the stakes are real. Day to day, you'll partner with perception, planning, controls, and hardware to define clear entry/exit criteria, instrument systems for truth, and turn logs into actionable insights that raise reliability every week. If you love breaking things so customers don't have to, care deeply about measurable safety, and want your rigor to translate into robots that confidently tackle the world, this is the role for you.What You'll Get To Do: Own end-to-end V&V for autonomy stacks Define test strategies for perception, planning, and control across vehicle and robot platforms Build SIL/HIL pipelines for continuous regression and performance tracking Establish entry/exit criteria, traceability, and sign-off gates Level up our simulation & scenario coverage Develop realistic, adversarial scenarios (terrain, weather, lighting, sensor faults) Create large-scale batch tests using scenario generators and digital twins Calibrate sim-to-real via data replay and hardware characterization Engineer reliable test infrastructure Implement CI/CD integrations (build, artifacting, test orchestration, dashboards) Develop tooling for log capture, triage, and automated failure bucketing Track metrics: requirement coverage, code coverage (incl. MC/DC), and safety KPIs Prove safety and reliability in the field Plan and run structured field validations for off-road, legged, and humanoid use cases Execute fault-injection and degraded-mode testing with clear escalation paths Produce evidence packages for internal design reviews and external stakeholders What You Have: 2-5+ years in software or robotics V&V, QA, or test infrastructure (or equivalent research/industry experience) Strong coding in Python and/or C and/or C++ for test harnesses, automation, and analysis Hands-on with ROS/ROS 2, bag tools, and robotics logging/telemetry workflows Experience designing SIL/HIL setups, simulators, and scenario-based testing at scale Familiarity with autonomy components (perception, localization, mapping, planning, control) Proficiency with CI/CD (e.g., GitHub Actions, GitLab), containers, and build systems (CMake) Comfort with sensors and data: cameras, LiDAR, IMU, joint/force sensors; calibration & synchronization basics Clear, concise technical writing: test plans, results summaries, risk registers, and release notes A pragmatic, evidence-driven mindset and bias for automation over manual toil The Extras That Set You Apart: Domain experience in off-road autonomy (unstructured terrain, slip, wheel/track dynamics) Experience with legged/humanoid robots (whole-body control, contact/force validation) Deep simulation chops: Isaac Sim, Gazebo custom scenario engines Fault-injection and robustness testing (sensor dropouts, time skew, GPS denial, actuator faults) Statistical testing & evaluation: scenario coverage metrics, outlier analysis, reliability modeling ML evaluation experience (perception KPIs, dataset curation, drift detection, labeling QA) Tooling you can show: log diff/visualization tools, test dashboards, scenario libraries Field test operations in challenging environments; strong safety discipline and test readiness reviews Compensation and BenefitsOur salary range is generous ($70,000 - $200,000 annual), but we take into consideration an individual's background and experience in determining final salary; base pay offered may vary considerably depending on geographic location, job-related knowledge, skills, and experience. Also, while we enjoy being together on-site, we are open to exploring a hybrid or remote option. Why Join Field AI?We are solving one of the world's most complex challenges: deploying robots in unstructured, previously unknown environments. Our Field Foundational Models™ set a new standard in perception, planning, localization, and manipulation, ensuring our approach is explainable and safe for deployment. You will have the opportunity to work with a world-class team that thrives on creativity, resilience, and bold thinking. With a decade-long track record of deploying solutions in the field, winning DARPA challenge segments, and bringing expertise from organizations like DeepMind, NASA JPL, Boston Dynamics, NVIDIA, Amazon, Tesla Autopilot, Cruise Self-Driving, Zoox, Toyota Research Institute, and SpaceX, we are set to achieve our ambitious goals. Be Part of the Next Robotics RevolutionTo tackle such ambitious challenges, we need a team as unique as our vision - innovators who go beyond conventional methods and are eager to tackle tough, uncharted questions. We're seeking individuals who challenge the status quo, dive into uncharted territory, and bring interdisciplinary expertise. Our team requires not only top AI talent but also exceptional software developers, engineers, product designers, field deployment experts, and communicators. We are headquartered in always-sunny Mission Viejo (Irvine adjacent), Southern California and have US based and global teammates. Join us, shape the future, and be part of a fun, close-knit team on an exciting journey! We celebrate diversity and are committed to creating an inclusive environment for all employees. Candidates and employees are always evaluated based on merit, qualifications, and performance. We will never discriminate on the basis of race, color, gender, national origin, ethnicity, veteran status, disability status, age, sexual orientation, gender identity, martial status, mental or physical disability, or any other legally protected status.
    $70k-200k yearly Auto-Apply 60d+ ago

Learn more about validation engineer jobs

Top companies hiring validation engineers for remote work

Most common employers for validation engineer

RankCompanyAverage salaryHourly rateJob openings
1Stryker$93,364$44.893
2Volkswagen Group of America$85,982$41.340
3John Deere$85,342$41.032
4VALSPEC$81,939$39.392
5Steris$65,313$31.402

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