Validation Specialist Jobs Near Me

Rambus, a premier chip and silicon IP provider, is seeking to hire an exceptional PE Validation Engineer to join our Memory Interface Chip business unit. Candidates will be joining some of the brightest inventors and engineers in the world to develop products that make data faster and safer. As a PE Validation Engineer, the candidate will be reporting to the Dir Applications Engineering and is a Full position and the candidate will work in the lab to execute system validation, automate data collection, develop validation environment, and check system performance and specification compliance. The candidate will gain experience with processor-memory interfaces, including DDR topologies and protocols, as well as high-speed signaling, including signal integrity and power integrity concepts. Rambus offers a flexible work environment, embracing a hybrid approach for the majority of our office-based roles. We encourage employees to spend an average of at least three days per week working onsite, allowing for two days of remote work. Location(s): Atlanta, GA; San Jose, CA; Agoura Hills, CA; Chapel Hills, NC Responsibilities Lab bring-up and validation of high-speed memory buffer semiconductor products. Develop test methodologies for validating silicon designs against specifications. Develop scripts for automating lab equipment and for analyzing lab data. Experience in one of the following: ATE, System Testing or Bench Testing Support Applications Team in understanding and resolving customer issues. Work with silicon design teams to develop experiments, drive data collection, and present results analysis. B.S. or M.S. degree in Electrical Engineering. Fast learner with interest in hands-on lab work and writing software for lab automation. Must be a team player, works well with other lab engineers and circuit designers. Qualifications Knowledge of processor / memory system architecture. Understanding of high speed interface concepts, including signal integrity. Working knowledge of test and measurement equipment, troubleshooting and debugging. Experience on programing languages Python, C/C++. Hands-on hardware experience with x86 computer systems, Intel Server platforms, and/or AMD Server platforms. About Rambus Rambus is a global company that makes industry-leading memory interface chips and Silicon IP to advance data center connectivity and solve the bottleneck between memory and processing. With over 30 years of semiconductor experience, we are a leading provider of high-performance products and innovations that maximize the bandwidth, capacity and security for AI and other data-intensive workloads. Our world-class team is the foundation of our company, and our innovative spirit drives us to develop the cutting-edge products and technologies essential for tomorrow's systems. Rambus offers a competitive compensation package including base salary, bonus, equity, matching 401(k), employee stock purchase plan, comprehensive medical and dental benefits, time-off program, and gym membership. The US salary range for this full-time position is $128,500.00 to $238,700.00. Our salary ranges are determined by role, level and location. The successful candidate's starting pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. Rambus offers a competitive compensation package, including base salary, bonus, equity and employee benefits. Rambus is committed to cultivating a culture where we actively seek to understand, respect, and celebrate the complex and rich identities of ourselves and others. Our Diversity, Equity, and Inclusion initiatives are geared towards valuing the differences in backgrounds, experiences, and thoughts at Rambus to help enhance collaboration, teamwork, engagement, and innovation. At Rambus, we believe that we can be our best when every member of our organization feels respected, included, and heard. Rambus is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, or other applicable legally protected characteristics.

We are seeking a detail-oriented Validation Specialist to execute the day-to-day activities of our calibration and validation program, adhering to established procedures, deliverables, and monitoring requirements. The role involves developing, reviewing, and executing validation lifecycle documents for equipment and facilities commissioning as per the validation master plan and internal SOPs. The candidate will also assist in sourcing and implementing electronic CAL/PM systems for equipment management and perform calibration and certification activities. Responsibilities * Execute the calibration and validation program's day-to-day activities, adhering to established functional procedures, deliverables, and monitoring requirements. * Develop, review, and execute validation lifecycle documents for equipment and facilities commissioning, as outlined in the validation master plan and internal SOPs (e.g., Validation Plans, Protocols, Reports, URS, Technical Specifications). * Assist in sourcing and implementing electronic CAL/PM systems for equipment management. * Perform and document calibration and certification activities, coordinating with external vendors when needed. * Support GMP facility operations by coordinating validation-related activities. * Initiate deviations, conduct investigations, perform impact assessments, and support the development of corrective and preventive actions (CAPAs) and change controls. * Assist with the development of risk assessments and support validation activities for product commercialization. * Execute cleaning validation and verification processes for facilities as required. * Ensure compliance with regulatory requirements, the Validation Master Plan, and internal SOPs during validation activities. * Collaborate with facilities and equipment technicians to support maintenance, troubleshooting, and improvements in alignment with production and quality goals. * Maintain accurate records for all equipment and systems to ensure ongoing compliance with cGMP standards. * Support audits and inspections by regulatory agencies, providing necessary documentation and responses as needed. Essential Skills * Bachelor's degree in engineering, Life Sciences, or a related field. * Experience (3-5 years) in validation and calibration within a GMP-regulated industry (beverage, biotech, pharmaceutical, personal care). * Working knowledge of GMP regulations and guidelines (e.g., FDA 21 CFR Part 210/211). * Familiarity with calibration principles, validation methodologies, and risk-based approaches. * Strong organizational and documentation skills, with an eye for detail and quality compliance. Additional Skills & Qualifications * Experience performing validations on tanks, fillers, water systems, and cleaning systems. * Experience with equipment commissioning, facilities infrastructure, and protocol writing. Work Environment This position is 100% onsite, with working hours from 8 AM to 5 PM. Pay and Benefits The pay range for this position is $80000.00 - $100000.00 Health Insurance: Medical, dental, and vision coverage. Retirement Plans: 401(k) or other retirement savings plans, often with employer matching. Paid Time Off (PTO): Vacation days, sick leave, and holidays. Life Insurance: Basic life insurance policies, sometimes with options to purchase additional coverage. Disability Insurance: Short-term and long-term disability coverage. Flexible Work Arrangements: Options for remote work, flexible hours, or hybrid schedules. Bonuses: Performance-based bonuses, signing bonuses, or referral bonuses. Professional Development: Opportunities for training, certifications, and continuing education. Employee Assistance Programs (EAPs): Support services for personal and work-related issues. Workplace Type This is a fully onsite position in Azusa,CA. Application Deadline This position will be accepting applications until Jan 31, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

**Job Type:** Full Time **Education:** B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences **Skills:** Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding Job Summary Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based IRT Validator to join our Randomization and Study Product Management team in Mumbai, India. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. **Responsibilities** * Creation of test plans; * Execution of test plans and creation of validation packages; * Review of validation packages created by other team members; * Review requirement specification documents provided by internal clients; * Validation of new projects and changes to existing projects; **Qualifications** * Bachelor's degree in Math, Computer Science, or related field required; * Demonstrated ability to complete validation tasks within defined time frames and to appropriate quality levels; * Fluent in English. **Medpace Overview** Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. **Medpace Perks** * Hybrid work-from-home options (dependent upon position and level) * Competitive PTO packages * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Flexible work schedule * Competitive compensation and benefits package * Structured career paths with opportunities for professional growth **Awards** * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

Job Details Experienced California Office - Roseville, CA Fully Remote Full Time High School $80,000.00 - $95,000.00 Salary/year None Day InsuranceAPC Coding Validation Specialist Who we Are As a leading healthcare intelligence company with over 40 years of experience, we put our unrivaled payment integrity, subrogation, and coordination of benefits (COB) expertise, expansive perspective, and relentless focus to work for our clients-ensuring no stone is left unturned in our pursuit of unmatched results. Our commitment to accuracy and excellence has helped us grow into a proven leader of our industry, relied on by companies large and small to help them maximize their return on investment. Location: This role is full remote About the Opportunity At NewCo, we're constantly reimagining what's possible in our industry-creating disruptively simple, powerfully clear ways to maximize our clients' financial outcomes today and drive down healthcare costs tomorrow. As part of the Complex Payment Solutions Team, as an APC Coding Validation Specialist, you will independently manage case reviews, validations, and reporting, ensuring efficiency, quality, and alignment with the company's mission. You will hold credentials such as, Certified Coding Specialists (CCS) with AHIMA, Certified Professional Coders (CPC) with AAPC, or Registered Radiation Oncology Coders (ROCC) and use your expertise, focus, and commitment to service excellence ensure the best outcomes for our clients. What you'll do Maintain a client-focused approach in all tasks. Conduct APC audits with 95% accuracy, contributing to overall recovery goals. Document audit findings accurately and effectively. Complete audits within assigned deadlines. Provide regular progress updates to the Manager, including detailed status reports. Actively collaborate as a member of the VARIS Service Team. Adhere to internal standards across all job responsibilities. Exhibit initiative and strong team-building skills. Attend departmental meetings as needed. Stay informed on coding changes and updates. Communicate professionally with clients, facilities, and staff. What experience you bring (Role Requirements) Certifications: (minimum of 1 of the following coding credentials required) Registered Health Information Administrator (RHIA), Registered Health Information Technician (RHIT), Certified Coding Specialist (CCS), CCS-P AHIMA Certified coding professional (CPC) AAPC Certified Interventional Radiology Cardiovascular Coder (CIRCC) AAPC Registered Radiation Oncology Coder (ROCC) Minimum 5 years of hospital outpatient/ambulatory coding experience, specializing in OPPS, APC, or related billing and reimbursement rules, or at least 4 years in OPPS/APC case validation. Strong oral and written communication skills. Extensive knowledge of APC/OPPS grouping, payment structures, and regulatory requirements. Proficient in complex outpatient medical record reviews to validate claim codes and APC/OPPS payments, including audits for compliance in areas such as ED CPT leveling, professional/facility fees, substance abuse, and mental health services (based on client scope). Expert understanding of coding conventions and guidelines, including Official Coding Guidelines, AHA Coding Clinic, CPT Assistant (AMA), and other relevant coding resources (e.g., radiation oncology). Skilled in using APC Grouper/Pricer software, coding encoders, and related computer applications. Willing to travel for annual training events. Adheres to AHIMA Standards of Ethical Coding. Must meet or exceed acceptable active time on system expectations during set business hours within the employee's time zone. What Success Looks Like… After 3 months You will have a strong understanding of the role. You begin building relationships and collaborating with peers. You develop effective time and priorities management. You receive initial feedback about your performance and are using it to improve. You've gained confidence in your abilities and are starting to feel more comfortable in your role. After 1 year You have mastered the tasks and responsibilities of the position, executing them with confidence and efficiency. You have established a strong network of internal relationships and are recognized as a key collaborator. You've been entrusted with greater responsibility indicating the company's confidence in your abilities. You see opportunities for career progression and personal development. Pay range: $80,000-$95,000 USD This is an exempt position. The salary range is for Base Salary. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location. What's in it for you PTO, Paid Holidays, and Volunteer Days Eligibility for health, vision, and dental coverage, 401(k) plan participation with company match, and flexible spending accounts. Tuition Reimbursement Eligibility for company-paid benefits including life insurance, short-term disability, and parental leave. Remote and hybrid work options At NewCo, we're reimagining a simpler way forward. This begins with our employees. We are innovators who value integrity, teamwork, accuracy, and flexibility. We do the right thing, and we listen to the needs of our clients and their members. As tenured experts with unmatched experience, we champion diverse perspectives that help us to better understand and serve our clients. Our values come to life through our culture. We embrace flexible working arrangements that allow our employees to bring innovation to life in the way that best suits their productivity. We work cross-functionally, abandoning silos, to bring innovative, accurate solutions to market. We invest in each other through ongoing education and team celebrations, and we give back to our communities through dedicating days for volunteering. Together, NewCo is making healthcare work better for everyone, and we're passionate about a future with better outcomes for all. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. NewCo is an employment at will employer. #INDHP #LI-VPM

We are looking for a Navy Qualified Validator (NQV) with substantive knowledge of NIST RMF and the NAVWAR Risk Assessment Guide. The ideal candidate will play a critical role in supporting the Risk Management Framework (RMF) Assessment and Authorization (A&A) processes for various Department of Defense (DoD) and Department of the Navy (DoN) systems, ensuring compliance with cybersecurity requirements and maintaining system integrity. Responsibilities RMF Package Development: Provide expert-level support in developing, reviewing, and validating RMF A&A packages in compliance with NIST SP 800-37, Navy RMF Process Guide (RPG), and NAVWAR Risk Assessment Guide. Ensure all documentation meets DoD and Navy requirements for system authorization. Validation Services: Serve as a trusted agent and technical representative to the Security Control Assessor (SCA), conducting thorough technical evaluations of systems to assess compliance with assigned security controls. Provide accurate assessments and document security posture, capabilities, and vulnerabilities. Artifact Development: Lead the creation of System Security Plans (SSP), Security Assessment Plans (SAP), and Security Assessment Reports (SAR). Execute custom test procedures and document results in government A&A tracking tools (e.g., eMASS). Risk Analysis: Perform detailed risk analysis, identify system vulnerabilities, and provide comprehensive recommendations for risk mitigation. Develop executive summaries to convey technical findings and risk assessments to stakeholders. Compliance Liaison: Collaborate with Program Managers (PM), Information System Security Managers (ISSM), and the SCA to ensure continuous monitoring and updates to RMF controls based on the CYBERSAFE grading and evolving cybersecurity requirements. Authorization Support: Assist in obtaining A&A approvals by ensuring all necessary documentation and artifacts are completed, accurate, and submitted in a timely manner to the appropriate Authorizing Official (AO). Provide guidance on corrective actions and recommendations for optimizing the RMF approval process. Requirements Must be 8570 Compliant. CISSP preferred Required Certification: Navy Qualified Validator (NQV) Level II or III. Expertise: In-depth knowledge of NIST SP 800-37, Navy RMF Process Guide (RPG), and NAVWAR Risk Assessment Guide. Experience with DoD A&A processes and cybersecurity compliance. Technical Skills: Proficiency in using government A&A tools (e.g., eMASS), conducting security assessments, and creating RMF documentation, including SAP, SAR, and SSP. Experience: Minimum of 5 years of experience in cybersecurity validation, risk assessment, and supporting RMF A&A processes for DoD and Navy systems. Security Clearance: Active Top-Secret clearance with Sensitive Compartmented Information (SCI) eligibility. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

• Experience implementing mobile field and CIS application framework and data models • Develop test plans, defining the scope, approach, resources, and schedule of testing activities • Develop test cases and procedures • Execute testing, and document and manage discrepancies • Develop strategies for regression testing, develop and maintain regression test cases and procedures • Develop and produce reports to communicate the status of testing activities, recommendations, and the resolution of discrepancies • Provide and utilize automated testing tools as appropriate Requirements 1. Strong experience (5+ years) 2. Experience with CIS and mobile field service data models 3. Experience leading major test efforts including the planning, development, and management of software testing programs, writing/executing test cases, and using different execution approaches and defect management processes 4. Experience developing test automation processes and strategies, including hands-on experience in supporting automated scripts execution in testing tools 5. Intermediate - expert level in Microsoft Suite, Teams

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations. We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G and Sequoia, 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 *********************** or *********************** POSITION OVERVIEW: Sequoia 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. COMPENSATION: Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $88,423.04 yearly in our lowest geographic market up to $125,935.84 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations. We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G and Sequoia, 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 *********************** or *********************** POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various processes. The Validation Engineer will be responsible for driving quality, performance, and overall compliance throughout the organization. This role includes the ability to lead a small project team of CQV (Commissioning, Qualification, and Validation) engineers. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Perform equipment qualifications including Commissioning, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Travel to various client sites to provide validation services. Write, review, approve, and execute validation protocols. Create reports summarizing results and statistics. Develop and communicate expectations for quality performance, continuous improvement, and quality systems. Assist developers and domain experts in designing, performing, and improving verification tests. Ensure the validation program meets GMP (Good Manufacturing Practice), FDA, and ISO regulations. Work with scientists, technicians, engineers, and project management to deliver equipment and facilities into a validated state. Interact with cross-disciplinary teams to meet project milestones and end goals. Collaborate with key stakeholders and client teams to define needs and achievable solutions and/or justifications for equipment requirements and related validation. Lead and mentor a small project team of CQV engineers. 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 : 5 - 7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA, cGMP, FMEA, Risk Analysis, and spreadsheet validation. Validation expertise in Equipment, CSV (Computer System Validation), Method, and Process disciplines. Protocol generation experience with an emphasis on computerized equipment and systems validation of automated production systems. Extensive experience writing validation and supporting documentation plus reporting for CQV and CSV. Knowledge, Skills, and Abilities : Strong leadership skills with the ability to lead a small project team of CQV engineers. Willingness to travel up to 100% for projects at client sites. ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $88,423.04 yearly in our lowest geographic market up to $125,935.84 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

**Indianapolis, IN** We're looking for a Verification and Validation Engineering Specialist to join our growing team. This is an exciting opportunity to work on flagship RR programs and play an important role in addressing some of the most complex and interesting technological challenges in Defense. As Verification and Validation (V&V) engineer, you will lead, plan and execute activities required for component, sub-system and product level test and reporting. In this role, you will actively participate in development projects as part of the project development team, and ensure testing is properly timed and executed to meet project delivery requirements. You will actively engage with design engineering and procurement to understand hardware delivery timelines and develop robust schedules and project plans to deliver a successful test program. **Innovate & Power the World** At Rolls-Royce, we look beyond tomorrow. We continually pioneer integrated power and propulsion solutions to deliver cleaner, safer, and more competitive power. We deliver the best jet engines in the world. Through intelligent innovation and active collaboration, we're putting our customers at the forefront of the aviation industry - and we keep them there. Our product portfolio powers more than 35 types of commercial aircraft, and with over 13,000 engines in-service around the world - we're keeping the world flying. Rolls-Royce is a Military Friendly Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. You can learn more . **Key Accountabilities** : * Define, derive, and allocate system and sub-system level requirements based on customer and regulatory input * This position will plan, manage, and develop engine/sub-system certification/qualification plans and participate in product introduction gated reviews * Define engine and/or sub-system verification strategies based on program requirements using structured verification methodologies * Understand experiment/test requirements and turn them into test plans, budgets, schedules and subsequently test instructions. Understand and articulate risks and opportunities to program leadership to support decision making * Lead integration activities between project teams and test to ensure instrumentation, controls, data acquisition, test limits, and test data recording are completed. Support on-site and off-site development engine/sub-system build and test activities * Ensure test evidence and reports are documented * Understand and apply standard development and test processes, in collaboration with the test engineers and test leadership, to ensure a successful test program **Basic Qualifications:** * Bachelor's degree in Mechanical, Electrical, Systems or Aerospace Engineering required at a minimum. Graduating between August 2024 and August 2025 * Minimum GPA: 3.0 * To be considered for this role, you must be a U.S. citizen with the ability to obtain and maintain a high-level security clearance **Preferred Requirements** **:** * Exceptional people skills * Experience managing and interpreting requirements, and developing test plans * Design, development and test experience in the aerospace or automotive industry * Experience working in a cross-discipline, cross-functional development team * Experience with product configuration control, quality systems, trouble reporting and root cause / corrective action * Experience with structured verification **Pioneer** the next generation of innovation. Join us and you'll develop your skills and expertise to the very highest levels, working in an international environment for a company known the world over for its brilliance. **Our People are our Power** We are an equal opportunities employer. We're committed to developing a diverse workforce and an inclusive working environment. We believe that people from different backgrounds and cultures give us different perspectives. And the more perspectives we have, the more successful we'll be. By building a culture of respect and appreciation, we give everyone who works here the opportunity to realize their full potential. You can learn more about our global Inclusion strategy . At Rolls-Royce we embrace workplace flexibility. Our teams work in onsite, hybrid and remote work environments based on work and personal requirements. The specific arrangements vary from team to team. Please ask us about how we work on this team. Relocation assistance is available. Closing Date: December 31st, 2024 ****Job Category**** Validation and Verification****Job Posting Date**** 23 Aug 2024; 00:08****Pay Range**** $58,750 - $88,124-Annually **Location:** Indianapolis, IN **Benefits** Rolls-Royce provides a comprehensive and competitive Total Rewards package that includes base pay and a discretionary bonus plan. Eligible employees may have the opportunity to enroll in other benefits, including health, dental, vision, disability, life and accidental death & dismemberment insurance; a flexible spending account; a health savings account; a 401(k) retirement savings plan with a company match; Employee Assistance Program; Paid Time Off; certain paid holidays; paid parental and family care leave; tuition reimbursement; and a long-term incentive plan. The options available to an employee may vary depending on eligibility factors such as date of hire, employment type, and the applicability of collective bargaining agreements.

**Post Silicon Validation Engineer** **Mission:** Leverage industry experience to lay the groundwork for creating a silicon validation and characterization platform with a strong focus on quality to provide the best possible devices to the datacenter and help drive future design improvements. **Responsibilities & outcomes:** * Responsible for developing an E2E system validation test plan for the SoC including characterization * Collaborate with the SW teams to develop a complete suite of tests that enable maximum system level coverage for validation and characterization * Collaborate with the HW teams to develop the optimum solution for test validation and characterization * Responsible for understanding the SoC design to collaboratively work with cross functional teams to create, modify, edit tests and suggest coverage improvements * Responsible for supporting correlation between system and other key platforms to enable a robust production plan **Ideal candidates have/are:** * 7+ years of experience in bring up and debug of high speed and high power SoCs * 7+ years of experience in silicon validation planning and leading a project from pre silicon planning, bring up, full SoC validation, and characterization to providing validation signoff before HVM * Comprehensive knowledge of Embedded software programming * Proficient in programming languages such as C, C++, Python, TCL and Shell scripts * Strong protocol knowledge in I2/I3C, SPI, UART, JTAG, and PCIe * Strong understanding of FPGA programming * Proficient in High Speed SerDes testing * Proficient in TCP IP, UDP, IPv4, IPv6 addressing, Ethernet, DHCP, and DNS * Hands on experience with high speed oscilloscopes and debugging embedded systems using logical analyzers * Basic understanding of how LLMs work * Some experience with DFT (Design For Test) * Experience in automation framework development using Python or any other language * Good knowledge of ASIC design flow and silicon FW development process * Flexible to adapt to a very dynamic environment and always carrying forward key improvements **Compensation:** At Groq, a competitive base salary is part of our comprehensive compensation package, which includes equity and benefits. For this role, the base salary range is $186,000 to $305,000, determined by your skills, qualifications, experience and internal benchmarks. **Location:** Groq is a geo-agnostic company, meaning you work where you are. Exceptional candidates will thrive in asynchronous partnerships and remote collaboration methods. Some roles may require being located near our primary sites, as indicated in the job description. **At Groq:** Our goal is to hire and promote an exceptional workforce as diverse as the global populations we serve. Groq is an equal opportunity employer committed to diversity, inclusion, and belonging in all aspects of our organization. We value and celebrate diversity in thought, beliefs, talent, expression, and backgrounds. We know that our individual differences make us better. *Groq is an Equal Opportunity Employer that is committed to inclusion and diversity. Qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, disability or protected veteran status. We also take affirmative action to offer employment opportunities to minorities, women, individuals with disabilities, and protected veterans.* *Groq is committed to working with qualified individuals with physical or mental disabilities. Applicants who would like to contact us regarding the accessibility of our website or who need special assistance or a reasonable accommodation for any part of the application or hiring process may contact us at: *************** . This contact information is for accommodation requests only. Evaluation of requests for reasonable accommodations will be determined on a case-by-case basis.* Select... If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Chantilly, VA **Armison Tech** is a minority owned small business, established in 2012, located in the Northern Virginia area. We're a company predominantly focused on cyber security for our government customers yet our expertise in other areas include big data analytics, instructional design, information management, and computer network infrastructure. We invest in our employees careers by participating in cutting edge cyber security training and attending industry leading conferences. As a small business we offer flexibility and powerful benefits supporting our most important assets, our employees and their families. **Armison Tech** is constantly searching for exceptionally qualified technology professionals who would make a great addition to our team. Our staff, just like our clients and the work we do, is what makes **Armison Tech** a truly effective partner. As we help each of our new employees make adjustments to our operational methods, we make sure every professional is able to handle the workload of each project by resolving any relevant concerns or issues they may have relating to this recent career shift. Our hiring process seeks to accentuate the raw talent and skill-set of our team members. Along with the importance of experience and education, **Armison Tech** looks for the superior analytical and communication ability that separates our employees from what we've seen while working with some similar companies. Individuals we employ must have a demonstrated ability to excel in high-pressure situations which have a real impact on the modern world so we can continue to keep pace with the competition and the evolving fields of technology. Currently we have an immediate need to add an experienced: **Independent Verification & Validation (IV&V) Engineer** **Location:** Chantilly, VA (on-site client environment) **Clearance:** TS/SCI with Polygraph **Compensation:** Competitive, Excellent Benefits **Only applicants with the active required security clearance and are U.S. Citizens will be reviewed.** As an IV&V Engineer on our team, you'll use your experience to work with our government customer to discover their cyber risks, understand policies, and develop a mitigation plan. You'll work with your client to translate security concepts, so they can make the best decisions to secure their mission critical systems. **The appropriate candidate should have experience with the following:** * Must maintain active/current TS/SCI with a polygraph clearance. * B.S. 10+ years or 14+ years equivalent experience in functional software testing. * Experience with Linux, and comfortability navigating Ubuntu Linux, and utilizing basic troubleshooting skills. * Demonstrated comfortability with scripting (Bash, etc.), as well as moderate to advanced skills with Python. * Experience writing, testing, and maintaining Python code, and an understanding of Python threading processes. * Knowledge of PyCharm IDE to write, build, and test Python code. * Moderate to advanced database skills, with experience coding database queries, MongoDB (or other no SQL databases). * Familiarity with Elasticsearch and other similar technologies. * Demonstrated VMWare skills, including experience with VMWare workstations, COTS (such as Ansible) automation scripts, and working with Docker in a shared VM environment. **Additional Qualifications:** * Experience with VMWare tools such as VSphere and ESXI. * Experience with Windows PowerShell. * Experience working with Full Stack or DevOps Developers and Engineers. * Experience working with cybersecurity/red teams. The duties and responsibilities listed in this job description generally cover the nature and level of work being performed by individuals assigned to this position. This is not intended to be a complete list of all duties, responsibilities, and skills required. Subject to the terms of an applicable collective bargaining agreement, the company management reserves the right to modify, add, or remove duties and to assign other duties as may be necessary. We wish to thank all applicants for their interest and effort in applying for the position; however, only candidates selected for interviews will be contacted. ***Armison Tech** is an equal opportunity employer. All applicants will receive consideration for employment, without regard to race, color, religion, creed, national origin, gender or gender-identity, age, marital status, sexual orientation, veteran status, disability, pregnancy or parental status, or any other basis prohibited by law.*

Our client is seeking a Design Validation Engineer who's Primary responsibility is to serve as resource to apply the practical knowledge Manufacturing besting practices in to a workflow that enhances the “Design” for manufacturability gauge R&R Essential Functions (other duties may be assigned): Focus on executing internal speed reducer design standards in accordance with the product's functionality along with manufacturing best practices Check and validate production designs against internal design standards Work with internal design team to incorporate design standards into the daily design workflow Participate in regular process improvement meetings with a cross functional departmental team Participate in Design Standard Review Improvement Meetings Minimum Qualifications: Bachelor's degree in Engineering, Manufacturing, or a related field Minimum of 2-3 years' experience in Design Manufacturing. High knowledge base on manufacturing best practices for fabrication, welding, and machining Good written and oral communication skills. Previous experience working on cross-cultural teams. Work Conditions & Physical Environment: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions. Must have the ability to sit for extended periods of time; exhibit manual dexterity to dial a telephone, to enter data into a computer terminal/typewriter; to see and read a computer screen and printed material with or without vision aids; hear and understand speech at normal levels and on the telephone; speak in audible tones so that others may understand clearly in person and on the telephone; ability to understand and follow oral and written instructions; physical agility to lift up to 25 pounds. Overnight travel required in accordance with business needs. The above statements describe the general nature and level of work being performed. This job description does not serve as a contract nor does it limit the employer's ability to establish or change the content, nature, or essential functions of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. Under the Americans with Disabilities Act (ADA) of 1990, reasonable accommodations will be considered for qualified individuals with a disability. Benefits include: Medical, Dental, Vision Paid Time Off- Including Volunteer Hours Life and Accidental Death Insurance (Company Paid) Short and Long Term Disability Insurance (Company Paid) 401K, 401K Match- Access to Certified Financial Planner Access to LinkedIn Learning YMCA discount and more! Hamdan Resources, LLC is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer (EEO/AA), making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. U.S. Citizenship and/or authorization to work within the U.S.is required for most positions.

Why Precision for Medicine? 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 Precision for Medicine, Manufacturing Solutions wants you to join our team. Who Are We? We are Precision for Medicine, Manufacturing Solutions, 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: Covid Vaccine is required prior to the Team Member's start date with exceptions for medical and religious accommodations when reasonable. 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 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$58,000—$63,000 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. © 2020 Precision Medicine Group, LLC 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.

T-Solutions is the company people want to work for and work with when seeking global services and innovative solutions. We employ highly qualified and uniquely skilled professionals who are committed to providing services with integrity. We are the preferred partner to deliver excellence and to enrich our clients, employees, and communities. Who We Are T-Solutions is a woman-owned, veteran-owned business headquartered in Chesapeake, Virginia that creates exceptional, responsive solutions to complex challenges for our global clients in the field of government contracting. We are an innovative, agile provider of specialized, technical solutions and an exceptional cache of capabilities that enable mission-critical operations and decision making. We provide the expertise and guidance needed to help customers succeed in today's era of defense, security, maintenance engineering, logistics, and business transformation. Our core competencies are aligned with the current needs of our customers; and those competencies anticipate and facilitate work with our customers to address their future needs. We are continually striving to adapt emerging and proven technologies to further enhance the abilities of our customers and partners. Essential Duties and Responsibilities Overseeing Navy Qualified Validator (NQV) activities and maintains/reports Assess & Authorization (A&A) status and issues. Conducting A&A activities in accordance with DoD/DON policy and DoD Enterprise Mission Assurance Support Service (eMASS) Certification and Accreditation (C&A)/A&A processes. Providing NQV support in-depth knowledge of all A&A subject areas (throughout Risk Management Framework (RMF) Steps 1 through 6) with in-depth familiarity and understanding of Navy IT sites, systems, and infrastructure. Recommending cybersecurity protection capabilities, and, in collaboration with system owners, advising implementation strategies as guidance and threats change. Consulting with System ISSEs and/or System Owners regarding incorporation of cybersecurity best practices into system development/modernization/management efforts. Supporting implementation of the RMF for assigned programs, organizations, and systems. Conducting comprehensive assessments of the management, operational, and technical security controls employed within or inherited by an information system to determine the overall effectiveness of the controls. Perform annual security reviews, annual testing of Information Assurance (IA) controls. Travel This position includes a low level of travel. Education, Knowledge, Experience, Skills, and Abilities Required A Bachelor's degree preferably in Information Systems, Computer Engineering, Computer Science or Cyber Security. NOTE: Five years of demonstrated experience to include computer security, military system specifications, DoD IA policies, network and systems configuration and administration, RMF, Platform IT, implementation of Cyber Security and IA boundary defense techniques and various IA‐enabled appliances may substitute for bachelor's degree. A Master's degree will substitute for two years of the relevant experience requirement. Must have at least 12 years of relevant professional experience to include: RMF process, system analysis, system audits, CISCO iOS, MS Window/Server, LINUX, network and system monitoring tools, IA compliance models and tools, IA control validation, risk management, incident response, system security officer responsibilities, and securing and validating DoD systems. Within the period of relevant experience, must have a minimum of two years working in Research, Development, Test & Evaluation. Familiarity with eMass. Familiarity with ACAS. Certificates, Licenses, Registrations Current Operating System or Networking Technology certification (relevant to position). Must have current DoD 8570.01M (or superseded DoD manual) IAM/IAT Level III certification. Must have Navy Qualified Validator certification in accordance with DoDI 8510.01. Qualifications Must have an active Secret clearance. Must be a U.S. citizen. Must maintain the capacity to communicate with their supervisor and/or manager when not in the office. Physical Requirements Sitting for long periods of time, standing, walking, crouching, and kneeling. Reaching, handling, using equipment, keyboards, and mobile devices. Ability to lift items weighing up to 50 lbs. T-Solutions is proud to be an Affirmative Action/Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. T-Solutions is proud to be a Veteran-Friendly Employer. It does not discriminate against qualified applicants because of their status as a protected veteran or their relationship or association with a protected veteran, including spouses and other family members.

T-Solutions is the company people want to work for and work with when seeking global services and innovative solutions. We employ highly qualified and uniquely skilled professionals who are committed to providing services with integrity. We are the preferred partner to deliver excellence and to enrich our clients, employees, and communities. Who We Are T-Solutions is a woman-owned, veteran-owned business headquartered in Chesapeake, Virginia that creates exceptional, responsive solutions to complex challenges for our global clients in the field of government contracting. We are an innovative, agile provider of specialized, technical solutions and an exceptional cache of capabilities that enable mission-critical operations and decision making. We provide the expertise and guidance needed to help customers succeed in today's era of defense, security, maintenance engineering, logistics, and business transformation. Our core competencies are aligned with the current needs of our customers; and those competencies anticipate and facilitate work with our customers to address their future needs. We are continually striving to adapt emerging and proven technologies to further enhance the abilities of our customers and partners. Essential Duties and Responsibilities Overseeing Navy Qualified Validator (NQV) activities and maintains/reports Assess & Authorization (A&A) status and issues. Conducting A&A activities in accordance with DoD/DON policy and DoD Enterprise Mission Assurance Support Service (eMASS) Certification and Accreditation (C&A)/A&A processes. Providing NQV support in-depth knowledge of all A&A subject areas (throughout Risk Management Framework (RMF) Steps 1 through 6) with in-depth familiarity and understanding of Navy IT sites, systems, and infrastructure. Recommending cybersecurity protection capabilities, and, in collaboration with system owners, advising implementation strategies as guidance and threats change. Consulting with System ISSEs and/or System Owners regarding incorporation of cybersecurity best practices into system development/modernization/management efforts. Supporting implementation of the RMF for assigned programs, organizations, and systems. Conducting comprehensive assessments of the management, operational, and technical security controls employed within or inherited by an information system to determine the overall effectiveness of the controls. Perform annual security reviews, annual testing of Information Assurance (IA) controls. Travel This position includes a low level of travel. Education, Knowledge, Experience, Skills, and Abilities Required A Bachelor's degree preferably in Information Systems, Computer Engineering, Computer Science or Cyber Security. NOTE: Five years of demonstrated experience to include computer security, military system specifications, DoD IA policies, network and systems configuration and administration, RMF, Platform IT, implementation of Cyber Security and IA boundary defense techniques and various IA‐enabled appliances may substitute for bachelor's degree. A Master's degree will substitute for two years of the relevant experience requirement. Must have at least 12 years of relevant professional experience to include: RMF process, system analysis, system audits, CISCO iOS, MS Window/Server, LINUX, network and system monitoring tools, IA compliance models and tools, IA control validation, risk management, incident response, system security officer responsibilities, and securing and validating DoD systems. Within the period of relevant experience, must have a minimum of two years working in Research, Development, Test & Evaluation. Familiarity with eMass. Familiarity with ACAS. Certificates, Licenses, Registrations Current Operating System or Networking Technology certification (relevant to position). Must have current DoD 8570.01M (or superseded DoD manual) IAM/IAT Level III certification. Must have Navy Qualified Validator certification in accordance with DoDI 8510.01. Qualifications Must have an active Secret clearance. Must be a U.S. citizen. Must maintain the capacity to communicate with their supervisor and/or manager when not in the office. Physical Requirements Sitting for long periods of time, standing, walking, crouching, and kneeling. Reaching, handling, using equipment, keyboards, and mobile devices. Ability to lift items weighing up to 50 lbs. T-Solutions is proud to be an Affirmative Action/Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. T-Solutions is proud to be a Veteran-Friendly Employer. It does not discriminate against qualified applicants because of their status as a protected veteran or their relationship or association with a protected veteran, including spouses and other family members.

About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs. More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications. Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens. Learn more about Civica's plans and progress at **************** Position Summary The Validation Engineer II will be responsible for leading the commissioning, qualification, and validation (CQV) to support the commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, and processes in support of the project, operations, and quality objectives. Working closely with system owners and related stakeholders (Operations, Engineering, Laboratories, IT, and Quality Assurance). This role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, reviewing, and executing related CQV documentation as well as related documents for the role (e.g., procedures and change control records). Serves as subject matter expert for CQV activities. Essential Duties and Responsibilities: * Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems. * Responsible for all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release. * Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays. * Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions. * Support the development of Standard Operating Procedures for new processes and equipment. * Interpersonal skills to manage interactions and achieve results across a range of functions within the site. It may also extend to external communication with system vendors. * Serve as Principal Investigator for validation-related excursions. * Contribute to the continuous improvement of validation processes and procedures. Basic Qualifications and Capabilities: * Bachelor's degree in engineering or relevant sciences and 8+ years of CQV experience. * 8 years' experience with sterile injectables, combo-devices, or biologics. * Advanced degrees or certifications relevant to the role is a plus. * Knowledge of regulatory requirements (cGMP, FDA, etc.). * Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment. * Self-directed with problem-solving, analytical, and technical skills. * Ability to think strategically and tactically (detail-oriented). * Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment. * Ability to lead, take ownership, and follow through on assigned projects. * Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work. * Experience in a process improvement environment, including change management and participating in Lean/Six Sigma project teams. * Ability to work autonomously within established guidelines, procedures, and practices. Preferred Qualifications: * Experience in a sterile fill-finish facility. * Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications. * Start-up experience preferred. * Experience with validation tools and processes, including temperature mapping and use of Kaye Validator

Job Title: Navy Qualified Validator Job Type: Contract Clearance: Top Secret SCI Who is Ardalyst Defense, LLC? Ardalyst Defense, LLC is a Maryland, Service-Disabled Veteran-Owned Small Business (SDVOSB) that provides engineering services and technical, analytical and cyberspace operations services to integrated U.S. government agency operations. Ardalyst personnel have decades of direct operations experience in full-scope Cyberspace Operations - at the Service, Joint and National Agency levels. Are you an Ardalyst? Ardalyst is a mashup of Ardent, meaning “passionate” and Catalyst, meaning “change agent.” To be an Ardalyst means to be passionate about creating and sustaining meaningful transformations. Speak your mind - Collaboration is at the heart of everything we do and our belief in diversity of people supports our goal for diversity in thought. Ardalysts (that's just what we call ourselves) come ready to contribute and find solutions. Focus On Your Strengths - We invest in understanding the strengths and weaknesses of each employee so that you can shine at what YOU do best. See Yourself Grow - Ardalysts have cited being encouraged to take educated risk, kick-start progress, and advance their skills as one of their favorite things about working at Ardalyst and we're determined to keep it that way. Job Description Our team, supporting our Navy customer, has an immediate need for a Navy Qualified Validator. In this role you will assess the security and compliance of information systems in the US Navy. Duties and Responsibilities Play a critical role in ensuring the security and compliance of information systems within the U.S. Navy Maintain the integrity and confidentiality of sensitive data and ensuring compliance with security standards Conduct thorough security assessments of Navy information systems using the Risk Management Framework (RMF) process Validate that systems adhere to approved security controls and policies Assess system vulnerabilities, risks, and potential threats Collaborate with stakeholders to address security gaps and recommend corrective actions Develop and maintain system authorization documentation, including Security Authorization Packages (SAPs) and Information System Security Plans (ISSPs) Create and update written system authorization artifacts Document findings, recommendations, and validation results Assist in identifying and mitigating security risks Evaluate the effectiveness of security controls Provide risk assessments to the Navy's Authorizing Official (AO) or Designated Accrediting Authority (DAA) Work closely with system administrators, security engineers, and other stakeholders Serve as a trusted agent to the Security Control Assessor (SCA) during the authorization process Ensure compliance with Navy and Department of Defense (DoD) cybersecurity policies and guidelines Required Skills/Qualifications 5 years of Navy Cybersecurity/Information Assurance experience 1?year of Risk Management Framework implementation Experience with NIST SP 800-53 security control implementation or assessment Experience with Security Technical Implementation Guide (STIG) and Assured Compliance Assessment Solution (ACAS) testing Experience creating Security Assessment Plans Experience with vulnerability analysis including mitigation/remediation actions Ability to support 25% travel requirements TS/SCI Security Clearance Bachelor's Degree Current Navy Qualified Validator (NQV) Designation DoD 8570.01-M IAT Level III or IAM Level II/III Certification - Examples: CompTIA Advanced Security Practitioner (CASP), Global Information Assurance Certification (GIAC) - Security Leadership Certification (GSLC), Certified Information system Security Professional (CISSP), or Certified Information Security Manager (CISM) Benefits Competitive salary commensurate with experience Paid Time Off (PTO) Paid Holidays 401(k) Retirement Plan Health, Dental, Vision and Life insurance Short Term and Long-Term Disability insurance Monetary assistance with training and certifications What Ardalyst Offers You? The chance to work with experienced technology entrepreneurs and world-class cyber operations experts who have successfully grown companies before. Plenty of opportunities to learn as well as apply your talents and previous experience. Disclaimer Ardalyst Defense, LLC is an EOE that empowers employees, no matter their race, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or other protected characteristic-to meet and exceed customer expectations and thrive in a collaborative and dynamic work environment.

Data Intelligence, LLC (DI) is searching for a full time NQV to support its Cybersecurity Information Technology contract in the Virginia Beach/Dam Neck area. This is an on-site position. Job Responsibilities Assess and document risk, perform security control assessments, and document compliant and failed security controls in eMASS. Recommend corrections to eMASS record. Assist with eMASS data entry requirements and population. Complete a Security Assessment Report (SAR), in conjunction with the SCA, based on the assessment results. Prepare the SAR Executive Summary, with all assessment results, for SCAL review. Perform a complete Risk Assessment of a systems or network's security controls, known threats and vulnerabilities. Support updates to the POA&M based on the assessment results. Ensure traceability of all vulnerabilities from raw assessment results to the POA&M. Support the continuous monitoring program as necessary. Required Skills/Experience NQV certification 5 or more years of experience with DoD Security Control Assessments, Information Assurance Certification and Accreditation Process (DIACAP)/ DoD Risk Management Framework (RMF), depth of experience with the Authorize step IAM Level II or Level III required. Expertise configuring, running ACAS/Nessus, other vulnerability scans Experience with eMASS (all phases) Data Intelligence, DI is an established small business that has supported the critical missions of our government clients since 2005. We provide full life cycle system development, systems engineering, cybersecurity, and supporting analytical and logistics support to C4ISR and other complex systems. We are an equal opportunity employer that offers competitive salaries, comprehensive benefits, a team-oriented environment, and opportunities for advancement. We work with Veteran's organization to proactively hire those who have served our country. We offer medical, dental, vision insurance, 401K, PTO and 11 paid holidays.

Why Precision for Medicine? 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 Precision for Medicine, Manufacturing Solutions wants you to join our team. Who Are We? We are Precision for Medicine, Manufacturing Solutions, 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: Covid Vaccine is required prior to the Team Member's start date with exceptions for medical and religious accommodations when reasonable. 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 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$58,000—$63,000 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. © 2020 Precision Medicine Group, LLC 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.