Validation specialist jobs near me

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.

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.

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]] Learn more about Grifols

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.** Learn more about Grifols (************************************** **Req ID:** 537178 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

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

The Senior Validation Engineer will join a highly skilled team responsible for managing the commissioning and qualification (C&Q) of fully automated packaging equipment for biotech drug products. Reporting to the Ultimate Solutions C&Q Lead or Characterization Lead, the Senior Engineer will take a leadership role in executing validation strategies and coordinating with client leads. This position also involves mentoring and overseeing Junior Validation Engineers, ensuring all validation deliverables meet project timelines and compliance standards. Key Responsibilities Lead packaging equipment validation activities including the development and execution of IQ, OQ, PQ protocols and traceability matrices. Coordinate and manage validation projects in alignment with client schedules and expectations. Oversee Junior Validation Engineers, providing technical guidance and ensuring quality of work. Ensure full compliance with FDA regulations, cGMP, and industry best practices throughout validation activities. Collaborate with cross-functional teams including Engineering, QA, and Operations to support successful commissioning and qualification. Generate, execute, and review validation documentation, protocols, and reports. Support packaging equipment field execution and troubleshoot issues during qualification phases. Participate in project planning meetings and provide regular status updates to client leads and internal stakeholders. Identify and mitigate project risks, proactively ensuring validation milestones are met on time. Adapt to changing schedules and priorities, including the ability to work extended shifts, weekends, and travel on short notice when required. Qualifications Bachelor's degree in Engineering, Life Sciences, or related field. Minimum 5 years of experience in equipment validation within biotech, pharmaceutical, or medical device industries. Proven expertise in validation lifecycle documents (IQ/OQ/PQ, protocols, traceability matrix, etc.). Solid understanding of FDA validation guidelines, cGMP, and regulatory requirements. Experience working in regulated manufacturing environments with complex, automated packaging systems. Strong technical writing and documentation skills. Ability to work independently, manage priorities, and lead project segments. Excellent interpersonal and communication skills. Willingness to work flexible hours and travel as needed (up to 25%). Ultimate Solutions USA, LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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.

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

: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** 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.

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.

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

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 Accountabilities: Conduct system verification, design and execute validation plans to ensure system solutions meet quality standards and required specifications. Perform embedded software validation, covering core modules such as drivers and firmware; identify issues through testing, drive optimization, and ensure software stability and reliability. Execute testing processes for software development tools, including but not limited to Propel SDK, Builder, and solution tools, to verify the functional integrity and usability of the tools. Take charge of the daily management and operation of the laboratory, including regular maintenance, calibration, and troubleshooting of equipment/instruments, to ensure the normal operation of the experimental environment. Coordinate the import and export business of laboratory materials, including process connection and document organization, to ensure compliant and efficient flow of materials. Proactively collaborate with development and validation teams, sync validation issues, and work together to promote the implementation of system/software validation work. Cooperate with departmental operation needs, participate in relevant collaborative tasks, and support the achievement of the department's overall work objectives. Required Skills Bachelor's degree in CS / EE or equivalent. Proficient in Python and C language, with a solid foundation in programming. Candidates with experience in C++ or Java will be given priority. Familiar with the operation and basic configuration of Windows and Linux operating systems. Skilled in using Office software such as PPT, Word, and Excel. Capable of independently completing slide creation, professional document formatting, and basic data organization. Ensure the output results are clear, standardized, and professional. Possess good English communication skills in both written and spoken forms. Have strong teamwork awareness, along with the ability to independently analyze and solve problems and efficiently promote task implementation.

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

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

Are You Ready?CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles- At CAI, we are committed to living our values-both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future- We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities1. Technical Responsibilities- Develop documentation for CQV activities- Write and execute protocols (field verification)- Develop summary reports at client sites2. Areas of Focus- Pharmaceutical facilities- Utilities- Equipment3. Project & Team Management- Plan and coordinate work- Direct small teams in document development and/or execution Qualifications and Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 2-4 years' experience in commissioning and qualification in a regulated industry- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus- Preferred experience in:- Facilities and equipment startup- Walk-downs and troubleshooting- Utilities (WFI, RO, HVAC)- Upstream/downstream processing- Purification, recovery- Building automation- Pharmaceutical manufacturing processes Critical CompetenciesInfluence Strategy- Pursues initiatives aligned with organizational strategy- Identifies strategic, innovative solutions- Anticipates emerging customer/market needs Satisfy the Customer- Understands and anticipates customer needs- Delivers high-quality solutions and service- Proactively maintains satisfaction and loyalty Plan for Success- Aligns business strategies with actionable plans- Anticipates risks and builds contingency plans- Secures resources for goal achievement Pursue Execution- Prioritizes time and resources effectively- Holds self and others accountable- Acts to overcome obstacles and improve quality Tailor Communication- Communicates clearly and professionally- Adjusts style to fit the audience- Explains technical concepts effectively Build Partnerships- Builds networks across functions- Encourages collaboration and breaks down silos- Involves stakeholders in decisions Influence Others- Builds support with sound rationale- Gains buy-in from decision makers- Encourages innovative thinking Develop Self and Others- Enhances interpersonal relationships- Models integrity and company values- Seeks out growth and breakthrough opportunities#LI-MV1We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

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.

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech , it's about more than just a job-it's about your career and your future. Your Role We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for pharmaceutical facilities, utilities, and equipment. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met. Develop and execute commissioning, qualification, and validation protocols for required equipment and systems. Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures. Identify and assess risks associated with CQV activities and develop mitigation strategies. Troubleshoot and resolve issues related to equipment and process performance. Collaborate with cross-functional teams to ensure alignment on CQV activities and project timelines. Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.). Additional responsibilities as required to drive successful validation project deliverables. Requirements Bachelor's degree in Engineering, Life Sciences, or a related field. Proven experience in equipment/facility/systems commissioning, qualification, and validation engineering in the pharmaceutical and/or biotech industries. Strong knowledge of regulatory requirements and industry standards. Experience with validation lifecycle management and risk-based approaches. Excellent analytical and technical problem solving skills. Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.) Effective communication and interpersonal skills. Proactive with strong organization, time management, and project management abilities. Excellent attention to detail with commitment to quality and compliance. Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Must be authorized to work in the US. No C2C at this time. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more. 401(k) and 401(k) matching PTO, Sick Time, and Paid Holidays Education Assistance Pet Insurance Discounted rate at Anytime Fitness Financial Perks and Discounts Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-TP1

Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles * At CAI, we are committed to living our values-both professionally and personally: * We act with integrity * We serve each other * We serve society * We work for our future * We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities 1. Technical Responsibilities * Develop documentation for CQV activities * Write and execute protocols (field verification) * Develop summary reports at client sites 2. Areas of Focus * Pharmaceutical facilities * Utilities * Equipment 3. Project & Team Management * Plan and coordinate work * Direct small teams in document development and/or execution Qualifications and Experience * Bachelor's degree in a science or engineering field (or equivalent experience) * 2-4 years' experience in commissioning and qualification in a regulated industry * Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus * Preferred experience in: * Facilities and equipment startup * Walk-downs and troubleshooting * Utilities (WFI, RO, HVAC) * Upstream/downstream processing * Purification, recovery * Building automation * Pharmaceutical manufacturing processes Critical Competencies Influence Strategy * Pursues initiatives aligned with organizational strategy * Identifies strategic, innovative solutions * Anticipates emerging customer/market needs Satisfy the Customer * Understands and anticipates customer needs * Delivers high-quality solutions and service * Proactively maintains satisfaction and loyalty Plan for Success * Aligns business strategies with actionable plans * Anticipates risks and builds contingency plans * Secures resources for goal achievement Pursue Execution * Prioritizes time and resources effectively * Holds self and others accountable * Acts to overcome obstacles and improve quality Tailor Communication * Communicates clearly and professionally * Adjusts style to fit the audience * Explains technical concepts effectively Build Partnerships * Builds networks across functions * Encourages collaboration and breaks down silos * Involves stakeholders in decisions Influence Others * Builds support with sound rationale * Gains buy-in from decision makers * Encourages innovative thinking Develop Self and Others * Enhances interpersonal relationships * Models integrity and company values * Seeks out growth and breakthrough opportunities #LI-MV1 $72,800 - $80,100 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: * Comprehensive Health Insurance coverage * 24 days of Paid Time Off * ESOP/401K - 15% Company Contribution (US Only) * Company paid Life Insurance * Company paid Long Term Disability We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Business Unit: Ops Digital Technology Innovation Employment Type: Contract Duration: 6+ months with likely extension Rate: $35-40/Hr with benefits Notes: Onsite New Albany, OH - must be local. Standard hours. 3 Key Consulting is hiring! We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client's Ohio computer systems validation. Top Must Have Skill Sets: Experience with testing tools (ALM, or Kneat or ValGenesis). Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. Understanding of industry standards and best practices for computer system validation such as GAMP 5. Must have experience with deviations IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery) Day to Day Responsibilities: Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc). Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies. Provide support on completion of validation deliverables as required per the project. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase. Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards. Support regulatory inspections and internal audits as required. Basic Qualifications: Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience 2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems). Experience with ALM or Kneat testing tool is plus. 2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management. 3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211. 4. Understanding of industry standards and best practices for computer system validation such as GAMP 5. Why is the Position Open? Supplement additional workload on team. Red Flags: cannot support onsite operations Overly long or irrelevant resume Exaggerated or vague job titles and responsibilities Lack of achievements or quantifiable results Interview Process: WebEx or onsite. We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team