Lead Validation Specialist
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.
Auto-ApplyGPU Pre-Silicon Validation Engineer
Remote job
Company: Qualcomm Technologies, Inc. Job Area: Engineering Group, Engineering Group > GPU ASICS Engineering Are you interested in exploring how top of the line GPU's work? Qualcomm's GPU PSE (Post-Silicon Engineering) team is a part of the Adreno GPU HW Development organization and is responsible for the overall quality of the Graphics IP in silicon. As a member of our GPU PSE team, you will be working closely with GPU architects, designers, verification and graphics software driver engineers to help validate and productize the next generation graphics core for mobile devices. In this position, you will be responsible for improving our pre-silicon validation coverage and test methodologies as well as creating GPU bring-up test-plans that validate both electrical and functional features within the GPU. Providing debug analysis, support and solutions for silicon issues that range from the internal level to OEM level. We are looking for highly motivated and creative engineers that enjoy working in a fast-paced, dynamic, environment with minimal guidance. Candidates must have extremely strong communication and teamwork skills and approach difficult challenges as learning opportunities.
Minimum Qualifications:
* Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, or related field and 4+ years of Software Engineering, Hardware Engineering, Systems Engineering, or related work experience.
OR
Master's degree in Computer Engineering, Computer Science, Electrical Engineering, or related field and 3+ years of Software Engineering, Hardware Engineering, Systems Engineering, or related work experience.
OR
PhD in Computer Engineering, Computer Science, Electrical Engineering, or related field and 2+ years of Software Engineering, Hardware Engineering, Systems Engineering, or related work experience.
Qualifications:
* Candidate will have a previous experience working in emulation and silicon environments.
* Experience in functional validation and debug of mixed-signal IP
* Experience in Post-silicon enablement and bring up
Preferred Qualifications:
* Master's degree or PhD in Computer Engineering, Computer Science, Electrical Engineering, or related field.
* 2+ years of relevant GPU experience. • Experience in functional validation and debug of mixed-signal IP
* Experience utilizing emulation environments for development and debug
* Debugging low level firmware, software, logic and electrical issues
* Familiarity with software driver interaction with GPU hardware
* Test planning and methodologies to expose low level problems
* Debug tools including JTAG and kernel debuggers
* GPU and SoC architectures
* GPU APIs (Direct3D/OpenGL/OpenCL)
* Understanding of power, performance and thermal on silicon environments
* Experience programming in C/C++/Python/Assembly
* Basic familiarity with Verilog/SystemVerilog
* Experience in dealing with various customer OEMs.
* Experience in the Android and Windows HLOS environments.
* Understanding of the latest graphics trends in mobile and PC gaming
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:
$161,800.00 - $242,600.00
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.
Compliance Validation Specialist - Part Time & Remote
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.
Auto-ApplyField Validation Specialist - West BU
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
Field Validation Specialist - North BU
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 in the Central or East 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!
#BiomatUSA
#LI-KS1
#LI-Remote
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]]
DRG Validation Specialist
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.
Silicon Validation Engineer 4
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…
8+ years of experience
Electrical Engineering degree with a strong desire to pursue an engineering career in Silicon Design Validation
Capability to lead small group of teams as tech lead.
Expertise in High Speed Serdes Interface characterization and protocol compliance testing such as PCIe/Ethernet/SDI/CoaXpress/JESD204, MIPI D-PHY, MIPI CSI/DSI-2, USB and DisplayPort/HDMI etc.
Expertise in high speed board design and signal integrity evaluation/debug.
Expertise in Verilog/VHDL and design implementation using FPGA development tools.
Expertise in test automation development using programming languages such as Python, Perl.
Knowledge of statistical analysis concepts and use of analysis tools such as JMP, R.
Proficiency with bench equipment for device characterization such as BERT, VNA, Oscilloscopes, Protocol Exerciser/Analyzers.
Exposure on FPGA(emulation/prototyping etc)
Strong written and verbal communication skills to work with cross-functional team
Self-motivated and proactive with critical thinking.
Good problem solving and debugging skills.
Benefits
Benefits:
The base pay for this role is between $144,000 to $180,000 per year. In addition to base salary, we offer an incentive plan bonus, and new hire equity for a competitive total compensation package.
Lattice recognizes that employees are its greatest asset and the driving force behind success in a highly competitive, global industry. Lattice continually strives to provide a comprehensive compensation and benefits program to attract, retain, motivate, reward and celebrate the highest caliber employees in the industry.
Lattice is an international, service-driven developer of innovative low cost, low power programmable design solutions. Our global workforce, some 800 strong, shares a total commitment to customer success and an unbending will to win. For more information about how our FPGA, CPLD and programmable power management devices help our customers unlock their innovation, visit ******************** You can also follow us via Twitter, Facebook, or RSS. At Lattice, we value the diversity of individuals, ideas, perspectives, insights and values, and what they bring to the workplace. Applications are welcome from all qualified candidates.
Lattice
Feel the energy.
Auto-ApplyCDI Validation Specialist
Remote job
The CDI Validation Specialist assists the CDI Manager with oversight, evaluation, and analysis of CDI functions including efficiency, accuracy, continuing education needs, and overall quality. This individual identifies individual education needs of Clinical Documentation Specialists and collaborates with CDI Manager, IP Coding Manager, and IP Coding Validation Manager to develop appropriate training materials. The primary goal of ensuring the documentation in the chart identifies all clinical findings, diagnoses and procedures; and are appropriately and clinically supported. The CDI Validations Specialist will work with the CDI Manager to leverage performance, providing feedback and influence to continually improve documentation results thereby impacting key performance indicators.
Position: CDI Validation Specialist
Department: Clinical Documentation
Schedule: Full Time
ESSENTIAL RESPONSIBILITIES / DUTIES:
The CDI Validation Specialist functions primarily as an interdisciplinary auditor and educator focusing primarily on ensuring physician documentation is complete, accurate and representative of the care provided to the system's patients. To that end, the CDI Senior Validator will have access to physicians and clinical staff to participate in and assist in ensuring the ongoing documentation improvement effort is successful. The CDI Senior Validator will report directly to the CDI Manager.
Other functions include the following:
Monitors CDI staff accuracy, data quality and integrity.
Monitors CDS review process for content, timeliness and accurate diagnosis and procedure assignment in determining a working DRG.
Monitors concurrent queries for compliancy, accuracy, clarity, and timeliness.
Audits clinical documentation specialists retrospectively to assess for completes of chart review and query compliance including missed query opportunities, accurate coding, and adherence to AHIMA/ACDIS compliant query guidelines/standards
Collaborates with CDI manager to identify, coordinate, and implement CDI specialist ongoing education and feedback based on identified opportunities for improvement via auditing.
Assists in orientation and training of new clinical documentation specialists
Reviews and analyzes denial claims and denial data to provide support in denial prevention strategies via clinical validation query process and education to CDI specialists.
Contributes to departmental and organizational quality performance goals, including auditing mortality and readmission cohorts to identify opportunities for improvement. Coordinate and implement CDI specialist education based on identified opportunities.
Collaborates with CDI manager to create and update documentation tools, processes, procedures, and work flows on an ongoing and as needed basis.
Reviews charts concurrently with no MCC/CCs, low SOI/ROMs and LOS not supported by working DRG.
Identifies and educates CDI with missed query opportunities.
Assists CDI manager with final DRG validation when there is a discrepancy between CDS and coder.
Collaborates with the CDI Manager and identifies opportunities for performance improvement activities on processes.
Collaborates with CDI Manager, IP Coding Manager, and IP Coding Validation Manager to strategize appropriate training methodology for individual issues.
Provides timely appropriate feedback to CDI Manager on any performance improvement plans for CDI staff.
Collaborates with other CDCI department managers to identify areas for improvement and solutions for process improvement.
Assures documentation is compliant with federal and state regulations, coding guidelines and hospital policies.
Remains up-to-date in clinical and coding/documentation-related materials, including CDS best practices as defined by ACDIS as well as ICD-10-CM/PCS, AHA Coding Clinic guidelines for coding and reporting and MS-DRG/APR-DRG classification systems.
Monitors regulatory and reimbursement changes.
Serves as resource for CDI informational needs and updates CDI on coding changes, medical science and CDI practice standards.
Provides guidance, support and expertise to the CDI specialists
Track trends in documentation concerns and implementing solutions for improvement.
Uses leadership and critical thinking skills to identify opportunities for team processes and engagement
Recommend solutions for improvement when deficiencies are identified.
Provides CDI specialists, coders, and coding validation specialists with clinical feedback to assist in accurately capture diagnoses and/or opportunities for querying physicians post discharge for additional information.
Evaluates the success of concurrent documentation improvement on an ongoing basis.
Advances professional growth and development through participation in educational programs and workshops and maintaining knowledge of industry standards and practices.
Assists manager, when requested, in the development of APR/DRG/query response physician reports. Maintains complete confidentiality of patient information in addition to hospital and individual physician practice pattern data.
Assumes operational oversight of CDI department in the absence of the CDI manager.
Adheres to all BMC's RESPECT behavioral standards.
Other duties as assigned.
(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).
JOB REQUIREMENTS
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree (or equivalent) in nursing, health information management or related field and at least five years (5) years experience in clinical documentation, or equivalent combination of education and experience, required.
PREFERRED EDUCATION AND EXPERIENCE:
Master's degree
CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:
Licensed RN
CERTIFICATES, LICENSES, REGISTRATIONS PREFERRED:
CCDS, CDIP
KNOWLEDGE, SKILLS & ABILITIES (KSAs):
Demonstrate advanced knowledge of clinical documentation integrity practices, policies, workflows, and analysis.
Critical thinking, analytical and problem solving skills
Highly organized with strong project/task management skills
Knowledge of federal, state and payer specific regulations, policies and guidelines pertaining to coding (inpatient or outpatient), documentation requirements and billing
Experience with 3M Encoder/Grouper, SMART software preferred
Knowledge of care delivery documentation systems and related medical record documents.
Knowledge of age-specific needs and the elements of disease processes and related procedures.
Strong broad-based clinical knowledge and understanding of pathology/physiology of disease processes.
Excellent written and verbal communication skills.
Excellent critical thinking skills.
Demonstrated employee and medical staff relationships in the past and has the ability to maintain those going forward.
Working knowledge of inpatient admission criteria.
Ability to work independently in a time-oriented environment.
Computer literacy and familiarity with the operation of basic office equipment.
Assertive personality traits to facilitate ongoing physician communication.
Ability to be adapt to changes in the workload, to work independently and effectively prioritize work assignments
Working knowledge of Medicare reimbursement system and coding structures preferred, but not required.
Familiarity with physician practices, health information, case management or related healthcare discipline
Familiarity with all government health care reimbursement systems
Have experience working collaboratively with diverse groups in a health care environment
Demonstrated success in interacting effectively with physicians
Excellent speaking, writing and teaching skills
Proficient with standard Microsoft programs (i.e. MS Word, Excel, PowerPoint, Outlook) and web browsers.
Ability to analyze large amounts of data to identify trends.
Ability to provide direction and development to employees by coaching, identifying training needs, assigning progressively challenging projects, and assisting in career development planning.
Compensation Range:
$83,000.00- $120,500.00
This range offers an estimate based on the minimum job qualifications. However, our approach to determining base pay is comprehensive, and a broad range of factors is considered when making an offer. This includes education, experience, skills, and certifications/licensures as they directly relate to position requirements; as well as business/organizational needs, internal equity, and market-competitiveness. In addition, BMCHS offers generous total compensation that includes, but is not limited to, benefits (medical, dental, vision, pharmacy), discretionary annual bonuses and merit increases, Flexible Spending Accounts, 403(b) savings matches, paid time off, career advancement opportunities, and resources to support employee and family well-being.
NOTE: This range is based on Boston-area data, and is subject to modification based on geographic location.
Equal Opportunity Employer/Disabled/Veterans
According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received only through our website. We do not ask or require downloads of any applications, or “apps” job offers are not extended over text messages or social media platforms. We do not ask individuals to purchase equipment for or prior to employment.
Auto-ApplyFMS Verification & Validation Engineer- Aerospace Industry
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.
Auto-ApplyEngineer II, Validation
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
*
Auto-ApplyValidation Engineer
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.
Coding Validator Telecommute IP
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:
Mon-Fri Weekends possible-Flex
Work Shift:
Day
Daily Hours:
8 hours
Driving Required:
No
Sr. Navy Qualified Validator ( NQV) Philadelphia, PA
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
Auto-ApplySenior Battery Validation Engineer
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
Auto-ApplyProcess Validation Engineer, Expert
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
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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
Auto-ApplyADAS Feature Verification and Validation Engineer
Remote job
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Advanced Driver Assistance Systems (ADAS) Verification & Validation Application Engineer and focuses on ensuring the feature delivers the expectations of the customer. You will develop and implement feature requirements and specifications (including functional safety) for features like adaptive cruise control, automatic emergency braking, cross traffic alert, pro trailer features, advanced lighting, and 360 camera systems at a system and sub-system level and validate them according to the systems engineering model. As an Application Engineer, you will collaborate with research engineers, user experience teams, designers, hardware and software developers to define, develop, and verify the customer-facing attributes and performance capabilities of ADAS features. You will also develop new verification methods and work with vehicle, hardware-in-the-loop, model-in-the-loop and other advanced testing methodologies to validate your feature.
You'll have...
• B.S. in Electrical Engineering, Mechanical Engineering, or related technical field
Experience preferably in developing features in the Driver Assistance domain using radars, cameras, lidars, ultrasonic sensors and other related vehicle systems (body, electrical, chassis, powertrain)
Familiarity with actuators and control systems
Even better, you may have...
Masters in Engineering (Electrical, Mechanical, Aerospace, Mechatronics, Software, Computer Science, AI, Systems Engineering, Product Development) or related technical field
Experience applying Systems Engineering principles
Experience with robotic verification and testing methods
Troubleshooting experience with electromechanical systems
Experience with differential GPS equipment
Experience using typical automotive interfaces: CAN, CANFD, Autosar, Auto-Ethernet, etc.
Experience using Vector CANape, CANalyzer and dSPACE Controls Desk or similar tools
Experience with Matlab/Simulink
Experience in verification techniques (design verification methods, vehicle data acquisition/analysis)
Experience with virtual validation methods (HIL/MIL/SIL)
Strong leadership skills, passion for quality, passion to improve customer satisfaction
Good communications and project management skills
Strong oral & written skills
Ability to work both independently and take initiative when necessary
Strong teamwork & interpersonal skills
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder…or all of the above? No matter what you choose, we offer a work life that works for you, including:
• Immediate medical, dental, vision and prescription drug coverage
• Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
• Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
• Vehicle discount program for employees and family members and management leases
• Tuition assistance
• Established and active employee resource groups
• Paid time off for individual and team community service
• A generous schedule of paid holidays, including the week between Christmas and New Year's Day
• Paid time off and the option to purchase additional vacation time.
This position is a range of salary grades 6-8 .
For more information on salary and benefits, click here: *****************************
Visa sponsorship is not available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
Onsite work of up to four days per week will be required for candidates within commuting distance of a Ford hub location.
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What you'll do...
Define and document the vehicle-level acceptance criteria for ADAS features
Lead / support the development of verification plans and verification methods
Collaborate with global functional partners to meet system and vehicle level performance requirements
Cascade system-level requirements to functional partners
Lead/support the development and sign-off of ADAS features on vehicle programs
Support feature calibration studies to satisfy vehicle-level performance requirements
Develop MATLAB and CAN tools for data collection and analysis
Identify opportunities to utilize HiL and CAE methods for feature calibration and performance verification
Plan and execute real-world evaluations of ADAS features via vehicle/HIL/virtual testing and identify system problems and issues
Support and coordinate root-cause analysis with internal functions and external suppliers to ensure delivered system achieves feature requirements
Benchmark competitors and monitor public domain requirements
Auto-ApplyValidation Engineer
Remote job
:
Syner-G BioPharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.
We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality.
Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide.
Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second 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 hands-on Validation Engineer with a strong background in mechanical or manufacturing engineering, who brings expertise in automated manufacturing environments, preferably within the life sciences or biopharma industry. This role combines engineering document reviews, equipment startup support, and process/manufacturing engineering with project management and cross-functional communication responsibilities.
The ideal candidate will have experience in line layouts, fixture design, and 3D printing, with a preference for knowledge of filling and capping equipment. While this is not a controls engineering role, familiarity with PLCs and HMIs is required. The role also involves managing smaller projects and collaborating across teams to ensure successful execution in GMP-regulated environments. Proficiency in AutoCAD and SolidWorks is essential.
WORK LOCATION:
Travel to client sites may be required up to 100%, depending on project demands and client expectations.
KEY RESPONISIBILITIES:
Perform equipment qualifications including Commissioning, IQ, OQ, and PQ.
Provide hands-on engineering support during equipment startup and validation activities.
Conduct engineering document reviews and contribute to process improvement initiatives.
Write, review, approve, and execute validation protocols and reports.
Lead and mentor a small team of CQV engineers.
Collaborate with scientists, technicians, engineers, and project managers to deliver validated equipment and facilities.
Ensure validation programs meet GMP, FDA, and ISO standards.
Support design and execution of verification tests and validation strategies.
Coordinate with cross-functional teams and vendors to meet project milestones.
Contribute to layout planning and fixture design, leveraging 3D printing where applicable.
Communicate effectively across disciplines to define requirements and deliver solutions.
QUALIFICATIONS & REQUIREMENTS:
Education
:
Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field.
Technical Experience
:
5-7 years of experience in biotech, pharmaceutical, or medical device industries.
Strong understanding of GMP, FDA regulations, FMEA, and risk analysis.
Experience with validation disciplines including Equipment, CSV, Method, and Process.
Skilled in protocol generation and validation of automated production systems.
Proficient in AutoCAD and SolidWorks.
Familiarity with PLCs, HMIs, and automated manufacturing systems.
Experience with high-speed fill-finish lines is a plus.
Skills and Abilities
:
Strong leadership and project management skills.
Excellent communication and stakeholder engagement across functions.
Ability to manage vendors and contractors effectively.
Hands-on approach to engineering and problem-solving.
Willingness to travel up to 100% for client site projects.
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.
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 BioPharma Group 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 BioPharma is an E-Verify employer.
Auto-ApplyModel Validation Analyst
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.
Fully Qualified Navy Validator III (Remote)
Remote job
Ishpi Information Technologies, Inc. (DBA ISHPI) is passionate about providing our customers with technical solutions that satisfy their business needs. Through collaborative interactions with customers, team members, subject matter experts (SMEs), technical leaders, and partners we design practical solutions that solve real problems for major government and business organizations. As a member of our group, you will work with a team focused on delivering innovative business solutions using emerging technologies through proven successful methods.
Responsibilities
The Fully Qualified Navy Validator III will provide support to the Naval Surface Warfare Command in Philadelphia, PA. Shall assist with the preparation and submission of all RMF A&A and AO packages. All RMF activities shall follow the most current applicabledocuments including DON RMF Process Guide, DoD Instruction 8510.01, and the business rules of cognizant review offices for each package. Shall also produce and maintain RMF artifacts related to the authorization or de-authorization of assigned RMF packages, applications, and systems under the cognizance of NSWCPD.
Qualifications
Education: Requires a Bachelor's degree in Computer Science from an accredited university.
Work Experience: Ten (10) years of professional experience. Experienced in the management of IAT, certification agents and system engineers on the compliance requirements to achieve certification and accreditation IAW the DoD RMF program and the Department of Navy (DON) Chief Information Officer (CIO) IA Policy for PIT Systems. Ten (10) years of support to the DON or DoD, preferably as an IAM, Certification Agent and/or Designated Approval Authority and Certification Authority staff.
Certifications: Fully Qualified Navy Validator certificate. IAM Level II certification.
Security Clearance: Requires U.S. Citizenship and an active government security clearance.
“Ishpi Information Technologies, Inc. is an Equal Opportunity Employer. All qualified candidates will be considered without regard to legally protected characteristics.
Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified, you may be contacted for this and future openings.
Auto-ApplyEngineer II, Validation
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.
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