Validation specialist jobs near me - 73 jobs

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Ancillary Health Job Qualifications: Skills: Decision Making, Medical Record Abstraction, Microsoft Office, Time Management, Written Communication Certifications: None Experience: 3 + years of related experience US Citizenship Required: No Job Description: Validation Specialist Drive better health outcomes for our clients as a Validation Specialist at GDIT. Here, your work will impact many as you deliver healthcare expertise and services where they are needed most. Own this opportunity to advance not just the state of public healthcare and patient outcomes, but also your personal career growth. At GDIT, people are our differentiator. As a Validation Specialist you will help ensure today is safe and tomorrow is smarter. Our work depends on Validation Specialists joining our team to perform adjudications of hospital-reported data from acute-care inpatient and observation/outpatient admissions in accordance with contractual and organizational guidelines. HOW A VALIDATION SPECIALIST MAKES AN IMPACT: Investigate and adjudicate discrepancies between hospital and CDAC abstractions to determine the most accurate answer according to guidelines provided by the customer. Formulate well-written feedback comments that serve to educate and explain the supportive rationale behind the adjudications for external and internal stakeholders. Collaborate with Training, Quality, and Management to improve CDAC accuracy and efficiency. Perform medical record abstractions as needed in support of CDAC production goals and customer deadlines. Accurately enter data into the Provider Validation Tool (PVT), HAI, and QSRS abstraction/validation software. WHAT YOU'LL NEED TO SUCCEED: Education: High School Diploma/GED. Required Experience: 3+ years of related medical record and/or clinical experience. 2+ years of CDAC abstraction experience during which the individual achieved above average accuracy and productivity. Required Technical Skills: Reliable home internet and proficiency with Microsoft Office tools (Outlook, Word, Excel, and Teams). Required Skills and Abilities: Verbal and Written Communication, Decision Making, Time Management, Flexibility, Self-Motivation, Adaptability, Teamwork, Confidentiality. Preferred Skills: Innovation, Curiosity, Proactiveness, Problem-solving, Resourceful. Location: Primarily remote, but option to work at York, PA customer site is also available. GDIT IS YOUR PLACE: Full-flex work week to own your priorities at work and home. 401K with company match. Comprehensive health and wellness packages. Internal mobility team dedicated to helping you own your career. Professional growth opportunities including paid education and certifications. Cutting-edge technology you can learn from. Rest and recharge with paid vacation and holiday time. #GDITHealth #GDITFedHealthJobs The likely hourly rate for this position is between $23.30 - $27.38. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: None Telecommuting Options: Remote Work Location: Any Location / Remote Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. GDIT typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year. Paid leave and paid holidays are prorated based on the employee's date of hire. The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

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.

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

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 *************************************** Required: NoShift: DayDuration: No End DateJob Function: R&D

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

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

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

... 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.

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

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Division Specific Information CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally accept as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3,500 employees in over 15 countries work hard every day knowing that what they do matters. Location 4650 New Design Rd Frederick, MD How will you make an impact? As part of our distributed team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer. What will you do? As a Validation Engineer III, you will be responsible to interact with several departments to provide validation support for computer systems, equipment and processes, along with the critical utilities and facilities required for packaging operations at the site. You will ensure site compliance and all vital activities are performed on time to keep all validated systems in a validated state. This role requires full-time onsite presence at our Frederick, MD location. Responsibilities: Responsible for the preparation and execution of validation documentation (VP, IQ, OQ, PQ) as well as the generation of corresponding summary reports Position will support the generation of Process Performance Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, and PPQ. Generate, complete, and review protocols for controlled temperature units (Freezers and Coldrooms) and packaging equipment Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities. Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices) Analyze the results of testing and resolve acceptability of results against pre-determined criteria. Identify protocol discrepancies from established product or process standards and provide recommendations for resolving them Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols Coordinate with other departments or outside contractors/vendors to complete validation tasks Demonstrates and promotes the company vision of the 4 I's: Integrity, Intensity, Innovation and involvement Author SOPs (Standard Operating Procedures) and Validation Documentation within Documentum Conducts all activities in a safe and efficient manner Other duties may be assigned to meet business needs Education: A four-year, Bachelor of Science degree from an accredited college or university in an Engineering or Science field and 2-5 years of validation experience in a regulated industry or equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience Minimum Qualifications: Knowledge of Computer System Validation (CSV) Knowledge of Controlled Temperature Unit Operation and Management PC literacy including the ability to generate sophisticated documents in both Microsoft Excel and Microsoft Word Must have strong analytical skills Needs to be capable of multitasking and responding to shifting priorities Must have good communication skills, both written and verbal Must be results oriented Must have prior mechanical and process equipment experience Desired Qualifications: Knowledge of pharmaceutical packaging materials and equipment Physical Requirements Must be able to lift 35 pounds At Thermo Fisher Scientific, each one of our >100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner, and safer! Compensation and Benefits The salary range estimated for this position based in Maryland is $83,300.00-$128,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Quality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The Validation Engineer will evaluate the equipment/utility/system/procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the Validation Engineer must be approved by the client. Responsibilities include: Interact with clients and works closely with site manufacturing, engineering, and QA to develop validation documents. Travel to various client sites and work independently to complete tasks. Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at client sites. Exposure to validation aspects of facility start-up, redesign/retrofit, and expansion. Writes and executes qualification protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards. Conducts temperature mapping studies, including the operation of Kaye dataloggers, or equivalent. Review and approve documented test results and maintain records for later analysis. Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems. Able to read P&IDs, isometric drawings, and As-built drawings. Skill Level and Requirements: Ability to problem solve and troubleshoot. Technical writing ability and use of Microsoft Word, Excel, Power point, and Project Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired. Experience using statistical tools is a plus to analyze data captured during validation studies. Minimum Requirements: BS in a technical discipline (Engineering, chemistry, microbiology, biology) 2 - 5 years of experience in at least one of the following areas: equipment/utility qualifications, process validation, analytical method validation, or cleaning validation. Current driver's license and auto insurance Quality Agents offers a full suite of benefits for full-time employees including: Health, dental and vision insurance Life, AD&D and disability Insurance Health savings account for participants in our health plan 401k retirement plan Paid time off Paid holidays Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.

QED Systems, LLC, is currently recruiting a Risk Validation Analyst , to join our team at the Pentagon in Arlington, VA to support our HQDA G-3/5/7 Support Services contract. Support the Insider Threat (InT) hub with technical analysis of Army NIPR network usage, focusing on utilizing the Army MS 365 suite of tools to validate the Army's exposure to insider risks on the NIPR network. Provide a holistic analysis of network and User Activity monitoring (UAM) from all network feeds and data generated through the creation and maintenance of MS Purview Insider Risk Management (IRM) and UAM triggers and from other disciplines essential to InT Holistic Analysis (Human Resources, Counterintelligence, Law Enforcement, Personnel Security etc.). Assist in the horizontal review and analysis of data feeds from various intergovernmental agencies and outside sources to identify potential InT and IRM behaviors and indicators and report those findings to the designated government team lead or senior analyst. Provide interdisciplinary subject matter expertise in the analysis of feeds within the InT Hub and recommend disposition of inquiries. Develop analytical findings that outline thresholds of potential InT and IRM activity and compile documentation that supports these findings, utilizing all resources and tools provided, including but not limited to databases, data ingests, reporting, IRM, UAM, Publicly Available Information/Commercially Available Information, and any other sources/methods approved for use by the Insider Threat Program. Assist in inter-/intra-organizational communication and coordination across U.S. ACOMs, ASCCs, Direct Reporting Units (DRU), Army Law Enforcement, Security, Human Resources, Legal, Counterintelligence and Cyber agencies, and the Defense InT Management and Analysis Center (DITMAC). Provide recommendations to update the InT Hub standard operating procedures and business processes. Assist in developing and evolving an automated capability to data mine and analyzing large volumes of data to identify potential InT behaviors, indicators or concerns. Assist in the development of InT and IRM triggers, policies, and behavioral indicators list to assist the Army designated UAM Program and IRM capabilities to improve the accuracy of program collection and to facilitate timely analysis of data feeds across both classified and unclassified networks. Assist in the management of InT Records in accordance with National Archives storage and processing requirements. Update and maintain records on the InT Hub SharePoint, shared drives, and on subsequent systems of record. Assist in developing and presenting InT awareness and education products that aid Army commands in understanding the IRM capabilities, the InT Operations Mission, how to utilize the Hub, and how to execute proper mitigation actions necessary to reduce risk. As needed, prepare an annual InT Operations self-assessment report, information papers, executive summaries, and other related reports, including annual statistics on alerts, case production, InT heat maps across a global Army, and provide recommendations to mitigate threats to potential InT and IRM concerns. Support InT Program (InT) Hub in the development or rewrite of InT Operations Hub documentation, to include but not limited to, SOPs, EXORDS, Strategic Communication Documents, Policies and Doctrine to support InT and IRM Operations efforts within the Army. Support the Hub by participating in DoD and InT Program led by InT working groups. Required Skills & Experience: Detail-oriented with excellent technical, verbal, and written communication skills. Must have the ability to work within Government-provided software packages with emphasis on MS Office products, for example, Outlook, Word, SharePoint, PowerPoint, and Excel. Must be able to think critically and apply analytical methodologies to raw data to present clear and precise recommendations. Ability to focus on Mission requirements while tracking multiple competing priorities. Require minimal supervision in the fast-paced, critical environment of the Army Headquarters. Must be proficient in the Enterprise Task Management Software Solution (ETMS2) (formerly Task Management Tool). Ability to clearly articulate analysis through both oral and written communication. Ability to provide executive, technical, and administrative support to senior leaders. Demonstrated familiarity with IRM and UAM concepts and related tool sets. Required Clearance: ACTIVE CLEARANCE LEVEL REQUIRED: Top Secret w/ SCI eligibility Qualifications: Bachelor's degree required. At least five (5) years of experience required. Travel: Less than 10% travel is expected for this position. Travel may include continental United States and outside continental United States locations. Work Environment: This position will be co-located with the customer and other contractors in Government office spaces. While not generally authorized, telework may be required due to exceptional circumstances (extreme weather, pandemic, etc.). Physical Demands: Physical demands of this position include ability to: Be independently mobile. Communicate effectively with co-workers and customers. Withstand prolonged periods of sitting at a desk and computer use. Reasonable accommodation will be provided to enable individuals with disabilities to perform the essential functions. Position Type/Expected Hours of Work: This is a full‐time position, Monday through Friday. Flexibility around core hours. Travel may occur outside of normal core hours. Additional Information: Please note this job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Assigned tasks may vary, with or without prior notice, to effectively meet client requirements. Total Compensation: QED offers a competitive compensation package for full-time employees. Our total compensation package is value-based and negotiable depending upon the candidate's specific skills and applicable relevant experience. Benefits include: Paid Time Off (PTO) 11 Paid Holidays 401(k) Matching Medical, Dental & Vision Benefits Life Insurance, AD&D, and Short-Term & Long-Term Disability Professional Growth Opportunities Additional Benefits QED Systems, LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. QED Systems, LLC is an Equal Employment Opportunity and Affirmative Action Employer - Minority/Disabled/Veteran/Female

About Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology. Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world. Job Description: Who You'll Work With Join one of our 45 offices in the US as part of a committed team of over 1500 professionals, working directly with clients on projects that shape the world around us. As a contract professional with BW Design Group, you'll be welcomed into a rapidly growing business and empowered to make an immediate impact. You'll work alongside seasoned leaders, technical specialists, and subject matter experts within our Regulatory Compliance Practice to deliver the highest quality solutions with consistency and accuracy. What You'll Do You'll support both capital project CQV delivery and individual technical contribution solutions for our clients within the Life Sciences industry. You'll help clients implement critical changes to improve their performance and realize their most important goals through: Validation & Compliance Activities: Establish User Requirement Specifications for critical equipment and systems. • Assess risk across various aspects of systems' functions and focus efforts on critical quality aspects. Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes - employing industry's most progressive Digital Validation Tools • Prepare, execute, and manage commissioning and qualification documents for utility, facility, and process equipment • Perform FAT, SAT, IQ, and OQ documentation development and execution on Automated Systems • Conduct investigations and troubleshoot validation-related issues • Prepare comprehensive written validation reports. Project Management & Leadership: • Lead all aspects of client relationship development and project execution • Develop project plans, strategies, and manage project resources, budgets, and schedules • Oversee complete project lifecycle from concept through design, implementation, installation, commissioning, and startup • Manage multiple project responsibilities simultaneously with excellent organizational skills • Focus on project success related to scope, schedule, budget, and client satisfaction What You'll Bring Experience Requirements (Based on Role Level): • Validation Engineer II: Minimum 2-7 years project experience with validation of automation, packaging, utilities, and/or facilities in pharmaceutical or medical device environments • Sr. Validation Engineer: Minimum 7+ years demonstrated experience with pharmaceutical or medical device process and equipment validation • Sr. Project Manager: Minimum 10+ years project engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications. Technical Skills & Qualifications: • Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree) • Validation experience in automation, packaging, cleaning, computer systems, utilities, and/or facilities • Strong technical writing and oral communication skills • Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD) • Experience with entire project lifecycle from concept development through startup (preferred) Professional Attributes: Excellent leadership and organizational skills with ability to manage multiple responsibilities • Outstanding communication and interpersonal skills to interact with all levels of management, clients, and vendors • Flexibility with tasks and strong analytical capabilities • Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events. #LI-TH1 “Must be legally authorized to work in the United states without sponsorship” At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments. Company: Design Group

Note: Must be a US Citizen for this federal contract. The Validation Engineer is responsible for performing validation and engineering activities, conducting development studies, analysing and assisting in improving pharmaceutical systems and processes. Essential Functions Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports (interim / final) which summarize results, specification and its acceptance criteria. Performs annual re-qualifications of equipment, facility and utilities in accordance to GxPs. Responsible for creating validation project and progress reports - weekly and monthly. Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements. Provide Technical Inputs and develop strategy for various Equipment Transfer projects. Provide regular status updates to the department and program management. Closely works with the maintenance, facility and metrology teams to complete new equipment installation, calibration, and qualification activities in accordance to validation master schedule. Performs engineering assessment and writes investigation reports for any non-conformance. Additional Responsibilities Assists with engineering projects and performs other duties as assigned. Education: Bachelors Degree (BA/BS) BS: Chemical, Biochemical, Mechanical engineering in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required Experience: Years of experience is between 2 to 4 years, A minimum 2 years of direct validation experience is required. Skills: Proficient in MS Office. - Advanced Excellent technical writing skills - Intermediate Excellent oral and written communication skills. - Advanced Must be able for follow direction and execute assigned work independently, after initial training is completed - Advanced Ability to work both independently and in conjunction with a team - Advanced Specialized Knowledge: Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents Prior experience with process qualification and media simulation is a plus. Work Locations: Frederick MD Job: Engineering Job Type: Federal Contract (US Citizenship is a MUST) Additional Information All your information will be kept confidential according to EEO guidelines.

Why choose Project Farma? Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing organization. As a leader within the life science industry, we are constantly pushing the boundaries of what is possible and redefining the standards of excellence. Our dynamic team is composed of vibrant professionals who are passionate about delivering high quality work for our partners and changing the lives of patients across the globe. If you are driven by innovation, thrive in a fast-paced environment, love to travel and are ready to make a real impact, then Project Farma wants you to join our team. Who Are We? We are Project Farma, the leading advanced therapy technical operations consulting company in the life science industry. As a Patient Focused, People First delivery team, we are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines. Our manufacturing playbook has led to the creation of the largest and most mature advanced therapy manufacturing footprint in the world. We are an industry leader in providing project management, validation, engineering, quality/compliance, and consulting services to support our partners across the life science space in finding ground-breaking treatments and solutions. We believe that our culture of philanthropy, teamwork, training and development and commitment to the patient is the foundation to our teams' and partners' long-term success. Essential Job Function (Include but are not limited to): Create alignment with cross-functional client departments including but not limited to Validation, Manufacturing, Quality, Supply Chain, and Engineering. Provide hands-on support and troubleshooting for clients navigating the engineering life cycle of cutting-edge equipment and manufacturing processes. Perform due diligence on system and subject domains to generate high-quality project deliverables. Author technical documents such as SOPs, requirements specifications, testing protocols, summary reports, etc. Execute system and process validation protocols using GxP best practices. Proactively identify and escalate roadblocks and utilize critical thinking skills and knowledge of problem-solving skills to identify creative solutions to those problems and roadblocks. Contribute to and embody our Patient Focused and People First Mission through the involvement in professional development and philanthropic opportunities. Build meaningful internal and external relationships presenting Project Farma as a service to clients as needed. Qualifications: Education and Experience Required: Bachelor's degree in Life Science, Engineering, or related discipline and/or comparable military experience. Other Required: Full time on-site client presence Willingness to travel up to 100% or as required to support project and business needs. In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including: Competitive salary based on experience Aggressive bonus structure Medical, Dental, and Vision insurance effective your first day of employment 401k Plan with company match Paid Time Off and Company Paid Holidays Company Paid Maternity and Parental Leave Continuing Education Assistance Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid driver's license. Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$50,000-$240,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **Brief Job Overview** This is a hands-on, non-supervisory role within the Central Laboratory Operations (CLO) department of the Global Laboratory and Technical Operations (GLTO) division. The incumbent will execute and support routine validation activities, ensuring compliance with USP standards, regulatory requirements, and industry best practices. In addition, this role provides technical support to metrology operations, assisting in instrument calibration, qualification, and measurement system management. The position contributes to the continuous improvement of the validation program, aligning with USP's mission and strategic objectives, while supporting internal stakeholders and laboratory operations. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Associate Validation Engineer has the following responsibilities: + Work closely with laboratory staff in executing validation, metrology, and calibration activities. + Support equipment and instrumentation calibration, verification, maintenance, and qualification. + Maintain accurate, up-to-date logbooks, equipment records, and documentation in compliance with SOPs and regulatory requirements. + Perform necessary administrative functions such as filing paperwork, photocopying, and reviewing laboratory and department data. + Coordinate with vendors on scheduling and provide support during on-site visits, ensuring smooth and compliant execution of validation and calibration activities. + Demonstrate the ability to perform testing, troubleshooting, and technical work independently while following established protocols. + Assist in the development, implementation, and continuous improvement of laboratory validation and measurement system programs. + Ensure compliance with safety procedures, quality standards, and regulatory requirements in all laboratory activities. + Stay current with best practices, industry trends, and regulatory changes relevant to validation and metrology activities. + Perform other duties as assigned, supporting USP's mission and operational excellence. + Foundational understanding of regulatory requirements, accreditation standards, and ISO guidelines, and the ability to apply this knowledge to validation planning, documentation, and execution. + Strong interpersonal skills with the ability to collaborate effectively across cross-functional teams. + Comfortable communicating technical concepts to both technical and non-technical stakeholders. + Demonstrated adaptability in a fast-paced environment with shifting priorities. + Proactive problem-solver with strong critical-thinking skills and sound judgment. + Highly organized with strong attention to detail and consistent follow-through. + Ability to manage multiple tasks simultaneously while maintaining accuracy and compliance. + Self-motivated, with a strong sense of ownership and accountability in daily work. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Bachelor's degree in Engineering, Life Sciences, or a related fiel5d, with a minimum of one (1) year of relevant validation experience. + Knowledge of quality management systems, including **ISO 9001, ISO 17025** , and/or current Good Laboratory/Manufacturing Practices (GLP/GMP). + Familiarity with validation processes for laboratory instruments and software, including IQ/OQ/PQ. + Strong analytical and problem-solving skills, with the ability to document and communicate findings clearly. + Ability to work effectively with cross-functional teams and support compliance with regulatory requirements. + Ability to work effectively with diverse colleagues and customers in a cooperative and professional manner. **Additional Desired Preferences** + Basic troubleshooting skills hands-on experience with laboratory systems. + Familiarity with SQT qualification testing on Agilent and Waters Empower systems is a plus. + Exposure to laboratory software systems, such as Waters Empower, Waters NuGenesis Lab Management System (LMS), Waters NuGenesis SDMS, Rees Environmental Monitoring, and LabX. + Knowledge of other regulatory and quality standards, such as GAMP 5, 21 CFR Part 11, USP . **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Hourly Range: USD $32.97 - 41.85 per hour. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Laboratory/Production **Job Type** Full-Time

Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. Brief Job Overview This is a hands-on, non-supervisory role within the Central Laboratory Operations (CLO) department of the Global Laboratory and Technical Operations (GLTO) division. The incumbent will execute and support routine validation activities, ensuring compliance with USP standards, regulatory requirements, and industry best practices. In addition, this role provides technical support to metrology operations, assisting in instrument calibration, qualification, and measurement system management. The position contributes to the continuous improvement of the validation program, aligning with USP's mission and strategic objectives, while supporting internal stakeholders and laboratory operations. How will YOU create impact here at USP? As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments. The Associate Validation Engineer has the following responsibilities: Work closely with laboratory staff in executing validation, metrology, and calibration activities. Support equipment and instrumentation calibration, verification, maintenance, and qualification. Maintain accurate, up-to-date logbooks, equipment records, and documentation in compliance with SOPs and regulatory requirements. Perform necessary administrative functions such as filing paperwork, photocopying, and reviewing laboratory and department data. Coordinate with vendors on scheduling and provide support during on-site visits, ensuring smooth and compliant execution of validation and calibration activities. Demonstrate the ability to perform testing, troubleshooting, and technical work independently while following established protocols. Assist in the development, implementation, and continuous improvement of laboratory validation and measurement system programs. Ensure compliance with safety procedures, quality standards, and regulatory requirements in all laboratory activities. Stay current with best practices, industry trends, and regulatory changes relevant to validation and metrology activities. Perform other duties as assigned, supporting USP's mission and operational excellence. Foundational understanding of regulatory requirements, accreditation standards, and ISO guidelines, and the ability to apply this knowledge to validation planning, documentation, and execution. Strong interpersonal skills with the ability to collaborate effectively across cross-functional teams. Comfortable communicating technical concepts to both technical and non-technical stakeholders. Demonstrated adaptability in a fast-paced environment with shifting priorities. Proactive problem-solver with strong critical-thinking skills and sound judgment. Highly organized with strong attention to detail and consistent follow-through. Ability to manage multiple tasks simultaneously while maintaining accuracy and compliance. Self-motivated, with a strong sense of ownership and accountability in daily work. Who is USP Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: Bachelor's degree in Engineering, Life Sciences, or a related fiel5d, with a minimum of one (1) year of relevant validation experience. Knowledge of quality management systems, including ISO 9001, ISO 17025, and/or current Good Laboratory/Manufacturing Practices (GLP/GMP). Familiarity with validation processes for laboratory instruments and software, including IQ/OQ/PQ. Strong analytical and problem-solving skills, with the ability to document and communicate findings clearly. Ability to work effectively with cross-functional teams and support compliance with regulatory requirements. Ability to work effectively with diverse colleagues and customers in a cooperative and professional manner. Additional Desired Preferences Basic troubleshooting skills hands-on experience with laboratory systems. Familiarity with SQT qualification testing on Agilent and Waters Empower systems is a plus. Exposure to laboratory software systems, such as Waters Empower, Waters NuGenesis Lab Management System (LMS), Waters NuGenesis SDMS, Rees Environmental Monitoring, and LabX. Knowledge of other regulatory and quality standards, such as GAMP 5, 21 CFR Part 11, USP . Supervisory Responsibilities None, this is an individual contributor role. Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Compensation Base Hourly Range: USD $32.97 - 41.85 per hour. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.

* Provide support to NAVSEA Team Submarine (TEAM SUB) Submarine Ship Building (SHAPM) Program Offices and supporting organizations: PMS 397 - COLUMBIA Class Submarine Program Office, PMS 450 - VIRGINIA Class Submarine Program Office, PMS 351 - Future Attack Submarine (SSN(X)) Program Office, and SEA 05Z - Marine Engineering Competency Domain. * TEAM SUB is a combination of Program Executive Office (PEO) Strategic Submarine (PEO SSBN), PEO Attack Submarines (PEO SSN), and PEO Undersea Warfare Systems (PEO UWS) and the Direct Reporting Program Office, AUKUS Integration & Acquisition Office (AUKUS). The TEAM SUB concept divides the single submarine-centric organization into specific PEOs with the goal of enhancing the structures and processes in the submarine research, development, acquisition, and maintenance communities. Required Skills and Experience: Capable of performing the following functions: * Extensive knowledge and experience with RDT&E and Business IT systems and the phases of Certification and Accreditation (C&A) process. * Experience in an IA or C&A related field. * Satisfiy provisions of CNSS no. 4016 (Risk Analyst), Intermediate Level, but is not required to actually hold the certificate. * Demonstrate in-depth knowledge of all C&A subject areas. * Appy Navy C&A guidance to Navy C&A efforts. * Strong writing skills to develop and maintain System Security Plans (SSP), Contingency Plans, Privacy Impact Assessments, Certification Reports, Accreditation Reports, Plan of Action & Milestones (POA&M), and other C&A documentation. * Required: Must be certified in accordance with Navy Information Warfare Systems Command Manual - Qualification Standards, Responsibilities, and Registration Process For Navy Qualified Validators (NQV) Version 3.0 dated 16 October 2020, Section 2.1, NQV Level III Standards, Table 2: Qualification Standards for NQV Level III as follows. a - Certification: (1) Holds a DoD 8570.01-M IAM or IAT Level III Certification b - Education: (1) Bachelor's degree or higher-level degree in a technical or managerial related discipline1 (2) Completion of NAVWAR Introduction to the Navy Risk Management Framework 101 Course (NAVWAR-RMF-101)2 (3) Completion of the four-part Navy Validator Course (NAVWAR-NQV-201).2 (4) Defense Information Systems Agency (DISA) eMASS Training (Computer-based or Instructor- led session) (5) DISA Assured Compliance Assessment Solution (ACAS) Training (32-hour Computer-based or Instructor-led session) c - General Experience: (1) Five (5) or more1 years of practical experience in a Cybersecurity, Engineering, T&E or A&A related field d - Navy Experience: (1) Navy A&A: Experience independently performing all Validator activities, as defined in the RPG, for one or more Navy RMF Security Authorization Package(s). Package(s) must have achieved signature of the SAR by a Navy SCA within the past year, and (a) NQV must be listed as the Validator in the SAP, and identified as a Validator in eMASS (the Validator can ensure this is accomplished by initiating the SAR) (b) SAR must have received SCA Signature within the past 365 days (c) Validator must have achieved a proficient PTR (i.e., >70%) rating for validation of this system (2) Test & Evaluation: Experience in developing a SAP, and the associated validation procedures. Validator must demonstrate experience with regards to: (a) The steps to develop a SAP and associated validation procedures; (b) The appropriate verification (test) methods for different types of requirements, and (c) Test execution methods, and test data analysis e - Navy Knowledge: (1) Navy IT sites, systems and infrastructure: In-depth understanding of Navy IT sites, systems and infrastructure (Including NCS and PIT). Describe knowledge of the A&A considerations associated with at least 3 of the following: NMCI/NGEN, ONE-NET/IT-21, Navy Excepted Networks (NEN), Programs of Record (POR) Systems, RDT&E networks, Navy Platform IT (PIT), Navy Enterprise Data Center (NEDC) and Shipboard/Air/Submarine Tactical Systems and Network connectivity with Fleet NOCs. 1 A High School Diploma or High School Equivalency Certificate obtained from a HS equivalency test such as the General Education Development (GED) Test, High School Equivalency Test (HiSET), or Test Assessing Secondary Completion (TASC) test is acceptable with seven (7) years of practical experience in a Cybersecurity, Engineering, T&E or A&A related field. 2 Registration instructions for training courses can be obtained by visiting the provider website (i.e., Navy e- Learning, DISA, etc.) * Desired: 10 or more years of experience in an Information Assurance (IA) or C&A related field. * Desired: Familiarity with and understanding of Navy IT sites, systems and infrastructure. * Desired: Experience working with Navy C&A efforts as a Navy Validator. * Desired: Demonstrated oral and written communication skills to work closely with all levels of personnel involved in IT operations and technical aspects of systems. Degree Requirements: * Desired: Bachelor's degree in computer science. * Must be a U.S. citizen * A secret security clearance