Validation engineer jobs near me

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

: Crown Equipment Corporation is one of the world's largest material handling companies, with a reputation for award-winning product design, advanced engineering and technology, and superior after-sale service. Crown produces and sells a broad range of forklifts, batteries, chargers, automation and fleet management technologies that are revolutionizing the material-handling industry. Job Posting External Job Duties Test Equipment, Software and Methods - Design and develop special equipment software and methods as required to support assigned projects. Monitor active tests and experiments to ensure validity and quality of the work, perform analysis of results and write formal reports as required. Laboratory Operations - Support general laboratory operations. Supervise installation, operation and maintenance of specialized test systems and laboratory facilities as assigned. Planning and Scheduling - Coordinate activities at the work group level, provide technical expertise and detail during project planning; assist Project Validation Engineers and Engineering Supervisors with creation of project schedules. Technical Staff Supervision - When assigned, provide supervision at the task level to assigned staff. Provide support in area of expertise as required to lab or project staff. Miscellaneous - Review progress with supervisor. Perform other duties as assigned to include infrastructure projects, budgetary inputs, and procedural documentation. This position works fully onsite. Minimum Qualifications Bachelor degree in Mechanical or Vehicle Systems Engineering, or related degree (Non-degree considered if 12+ years of related experience along with a high school diploma or GED) Good verbal and written communication, organizational, math, computer, and analytical skills Ability to safely operate lift trucks Reliable transportation to travel locally between company locations during scheduled workday Ability to occasionally travel with overnight stays (0-5%) Preferred Qualifications Experience with parametric modeling (SolidWorks or NX) Experience with data acquisition equipment such as Somat or Dewesoft Experience with MTS hydraulic test equipment Work Authorization: Indefinite U.S. work authorized individuals only. Individuals with temporary visas are ineligible. Sponsorship for work authorization, now or in the future, is unavailable. No agency calls please. Compensation and Benefits: Crown offers an excellent wage and benefits package for full-time employees including Health/Dental/Vision/Prescription Drug Plan, Flexible Benefits Plan, 401K Retirement Savings Plan, Life and Disability Benefits, Paid Parental Leave, Paid Holidays, Paid Vacation, Tuition Reimbursement, and much more. EOE Veterans/Disabilities

EHR Test Engineer Full Telework US Citizenship We are looking for a candidate to lead testing for Electronic Health Record (EHR) systems, driving end-to-end strategies, automation, and regression efforts. Use your expertise in Cerner/Oracle Health and healthcare standards to ensure seamless, high-quality workflows that directly impact patient care while working fully remotely! The Senior Test Engineer will be responsible for the oversight and execution of test scripts, scenarios, evidence, and regression testing across the Electronic Health Record (EHR) workflows. Role Responsibilities Quality Assurance and Testing Standards: Drive quality testing solutions by planning and constructing test scripts using quality processes and methodologies for Accenture or its clients. Develop, update, and maintain quality testing standards and procedures. Develop, update, and maintain quality testing standards and procedures, including issue management and escalation. Optimize processes and methods to deliver quality work. Test Planning and Strategy: Develop end-to-end testing strategies. Define test plans and entry/exit criteria. Create test models (plans, data, and scripts), including test data. Allocate test resources to application tests in a multi-test environment. Test Execution and Coordination: Execute testing efforts by delivering application and component releases. Coordinate and execute regression testing, test automation, performance testing, functionality testing, and usability testing. Lead other testers on the testing team and manage testing process questions and issues. Performance Tracking and Metrics: Define and track test metrics, including code coverage, quality, and performance. Scheduling and Estimation: Determine and meet time estimates and schedules for testing efforts. Strategic Alignment: Adhere to the strategic direction set by senior management. Act independently to determine methods and procedures for new assignments. Make decisions that impact the team through regular consultation with senior management. Communication and Collaboration: Communicate effectively with clients and stakeholders. Minimum Qualifications Must be a US citizen. Must have a Bachelor's degree in Computer Science, Technology, Computer Information Systems, Computer Applications, Engineering, or related field. Must have at least 5 years of progressive post-baccalaureate experience in the IT industry. Must have experience in each of the following: Software Testing Providing solutions in planning, constructing, and executing test scripts Designing, developing, and implementing test plans and test cases Conducting defect triage meetings with development and business teams. Coordination of software testing activities (integrated testing, unit testing, user acceptance testing, production validation) Other Job Specific Skills Experience within the Healthcare or Provider Industry Experience with healthcare provider workflows including but limited to: Revenue Cycle, Ambulatory, Lab, Pharmacy, Supply Chain, and Telehealth. Experience with the Cerner/Oracle Health EHR Understanding of Health Integration Standards (DICOM / HL7 v2 / FHIR / C-CDA Standard) Experience with System Integration Testing

Responsibilities / Tasks GEA Group, founded in Germany in 1881, is a global leader in engineering solutions, serving industries such as food and beverage, pharma, dairy, and more. With over 18,000 employees worldwide and a strong U.S. presence since 1929, GEA combines the heritage of a well-established company with the innovation of a forward-thinking industry leader. At GEA, we're not just building equipment, we're building lasting careers with an average employee tenure range from 8 + years, reflecting the strong culture, growth opportunities, and support we provide. Start strong - Medical, dental, and vision coverage begins on your first day Recharge and refresh - Enjoy 12 paid holidays, including a flexible floating holiday, and 136 hours of PTO to relax or explore Invest in your future - A 7% 401(k) employer match helps grow your retirement savings faster Keep learning - Take advantage of tuition reimbursement to further your education or skillset Live well - Our wellness incentive program rewards healthy habits Get support when you need it - Access to a confidential Employee Assistance Program for personal or professional guidance Save smart - Flexible Health Savings and Spending Accounts to manage out-of-pocket expenses The typical base pay range for this position at the start of employment is expected to be between $75,000 - $85,000 per year. GEA Group has different base pay ranges for different work locations within the United States. The pay range is not guaranteed compensation or salary. The estimated range is the budgeted amount for the position. Final offers are based on various factors, including skill set, experience, location, qualifications, and other job-related reasons. You may be eligible for additional rewards, such as a discretionary bonus (based on eligibility) and/or equity awards. Position Summary The Test Engineer works closely with Process Engineers and the Test Center Manager to develop test equipment configurations and test plans to evaluate the performance of GEA drying systems. This role involves operating pilot plant equipment, collecting and analyzing test data, and preparing comprehensive reports to demonstrate compliance with customer specifications. This position may include handling or working near hazardous materials. GEA provides thorough initial and ongoing training on proper hazardous waste handling, management, and emergency response procedures relevant to this position. This position requires 5 days onsite at our Columbia, Maryland facility. Essential Duties and Responsibilities Responsibilities include, but are not limited to: Collaborate with the Test Center Manager, Process Engineers, and Sales Engineers to develop test setups and detailed test plans. Operate pilot plant equipment (e.g., dryers, atomizers, and other specialized equipment) in accordance with test requirements, making necessary adjustments based on test results. Perform minor repairs and maintenance on test station equipment as directed. Operate related machinery and tools such as forklifts, hand tools, and other support equipment. Accurately weigh, package, and prepare test materials for shipment. Collect, record, and organize data on operating conditions and maintain detailed logs of operations for inclusion in final test reports. Prepare and submit comprehensive test reports summarizing results and conclusions. Follow all safety protocols and material handling procedures, ensuring compliance with environmental, health, and safety regulations. Review and understand Safety Data Sheets (SDS) prior to working with hazardous materials and determine appropriate safety measures in coordination with the Test Center Manager and Health & Safety Coordinator. Perform other related duties as assigned by the Supervisor or Test Center Manager. Your Profile / Qualifications Qualifications and Requirements Bachelor's degree in Engineering (Chemical, or related field). Experience in pilot plant operations, process testing, or equipment commissioning preferred. Knowledge of drying technologies or thermal process systems is an asset. Strong analytical and problem-solving skills. Ability to work effectively in a hands-on, team-oriented environment. Proficiency with data collection, documentation, and reporting. Must be able to safely handle hazardous materials (training provided). Ability to operate forklifts and hand tools (certification or training provided as needed). Work Environment This position involves laboratory and pilot plant work, which may include exposure to noise, heat, or chemicals. Use of personal protective equipment (PPE) is required. At GEA, we don't just offer jobs, we offer opportunities to thrive, grow, and make an impact. #engineeringforthebetter GEA Group is committed to fostering an inclusive work environment where all clients and employees feel welcomed, accepted, and valued. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Did we spark your interest? Then please click apply above to access our guided application process.

Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials. What You'll Do As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Lead Validation Specialist Location: Princeton NJ and Remote - Preference given to applicants residing in the East Coast. We are seeking an experienced Senior Validation Specialist with experience in clinical systems to join our team. In this role, you will provide project leadership for the validation team and be responsible for ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11. You'll work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards. You'll be responsible for creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly. This is an ideal opportunity for someone who thrives in fast-paced, dynamic environments where adaptability, critical thinking, and initiative are essential. What You Need Bachelor's degree 8+ years prior experience inclusive of computer systems validation 5+ Years relevant experience in Leading a Validation Team Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+ Knowledge and understanding of Regulatory Guidelines for the use of computer systems Experience working with GxP regulations and 21 CFR Part 11 Experience mentoring and coaching teams Prior experience working in a Life Science regulated industry Prior project management experience, preferred Skills and Competencies Computer Systems and Technology: Strong knowledge of computer systems validation (SDLC, Agile methodologies) web technology, and cloud-based systems and proficiency with Computer skills including advanced knowledge of excel (e.g. Microsoft Word, Excel spreadsheets, PowerPoint, SQL) Analytical and Problem-Solving Skills: Ability to research, analyze system requirements, develop alternatives, and implement solutions Communication and Interpersonal Skills: Strong verbal and written communication skills as well the ability to work both independently and with cross-functional teams Time Management Skills: Highly organized, result-oriented, and a self-starter comfortable working in fast-paced environment with evolving priorities Additional Requirements Able to work effectively as an onsite or remote worker Must be highly fluent in English Willing to travel to meetings in Princeton, NJ as needed. Advance notice will be provided What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-150,000 with bonus potential. The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role. This position is not eligible for relocation or company provided sponsorship. Theradex is an Equal Opportunity Employer.

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

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

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

Lattice Overview There is energy here…energy you can feel crackling at any of our international locations. It's an energy generated by enthusiasm for our work, for our teams, for our results, and for our customers. Lattice is a worldwide community of engineers, designers, and manufacturing operations specialists in partnership with world-class sales, marketing, and support teams, who are developing programmable logic solutions that are changing the industry. Our focus is on R&D, product innovation, and customer service, and to that focus, we bring total commitment and a keenly sharp competitive personality. Energy feeds on energy. If you flourish in a fast paced, results-oriented environment, if you want to achieve individual success within a “team first” organization, and if you believe you can contribute and succeed in a demanding yet collegial atmosphere, then Lattice may well be just what you're looking for. Responsibilities & Skills What Will You Get to Do? Do you have a passion for invention and self-challenge? This position gives you an opportunity to learn and participate in one of the most cutting-edge projects that Lattice's Silicon Engineering team has embarked upon to date. We are validating building blocks in FPGA on board level to ensure functionality and performance aspect of Design intent. FPGA consists of various IPs as a building block such as SERDES(PMA/PCS), Memory DDR(DDR4, LPDDR4, DDR5 etc), DPHY, PLL, DSP, Fabric, I/O etc. As a Silicon Design Validation engineer, you will have an opportunity to learn and train yourself on how to validate one/or many of the building blocks within the FPGA. And also, you will be able to acquire knowledge on process/methodology required for validating certain IPs from planning to completion. While you are working on those, you will be exposed to cutting edge equipment and advanced boards as well as Various SW/tools/scripts. What you're going to be exposed to and learn: The ideal candidate is highly motivated in developing a career in Silicon Design Validation engineering. You will get significant exposure and training in the following areas: Chance to learn FPGA and it's build block such as SERDES(PMA/PCS), Memory DDR(DDR4, LPDDR4, DDR5 etc), DPHY, PLL, DSP, MIPI, Fabric, I/O etc but not limited. Validate and characterize various IPs from silicon arrival to release to production. Develop validation and characterization plans for certain IP, bench hardware and software. Develop test logic RTL to achieve intended validation/characterization test. Drive new silicon product bring-up, validation, debug to asses IP functionality/performance. Characterizing data sheet parameters. Analyzing the measured data with statistical view. Data sheet preparation etc. Serve as the central resource with design, verification, manufacturing, test, quality and marketing/apps as the product(s) move Silicon arrival to product release. Supporting customer issues as required to resolve issues found after product release You Have… 5+ years of experience Electrical Engineering degree with a strong desire to pursue an engineering career in Silicon Design Validation Expertise in High Speed Serdes Interface characterization and protocol compliance testing such as PCIe/Ethernet/SDI/CoaXpress/JESD204, MIPI D-PHY, MIPI CSI/DSI-2, USB and DisplayPort/HDMI etc. Expertise in high speed board design and signal integrity evaluation/debug. Expertise in Verilog/VHDL and design implementation using FPGA development tools. Expertise in test automation development using programming languages such as Python, Perl. Knowledge of statistical analysis concepts and use of analysis tools such as JMP, R. Proficiency with bench equipment for device characterization such as BERT, VNA, Oscilloscopes, Protocol Exerciser/Analyzers. Exposure on FPGA(emulation/prototyping etc) Strong written and verbal communication skills to work with cross-functional team Self-motivated and proactive with critical thinking. Good problem solving and debugging skills. Who Are We? At Lattice, we are good at collaboration and problem solving. We're also good at having a bit of fun. We develop technologies that we monetize through differentiated programmable logic semiconductor products, system solutions, design services and licenses. We are the low power programmable leader. We solve customer problems across the network, from the Edge to the Cloud, in growing communications, computing, industrial, automotive and consumer markets. Our technology, long-standing relationships and commitment to world-class support enable our customers to create a smart, secure, and connected world. Join Team Lattice…and help us continue to drive innovation that creates a smarter, better-connected world. Together, we enable what's next.

Job Description : A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. We are actively seeking qualified candidates to join our talent pipeline for future client engagements. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures. Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities. Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments. Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. Support the resolution of regulatory observations or manufacturing site issues. Execute periodic reviews and requalification for temperature chambers. QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education : Bachelor's degree in a related life science field. Technical Experience : 4-7 years of experience within the biotech, pharmaceutical, or medical device industry. Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment, CSV, Method, and Process. Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, and Abilities : Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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

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

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

Job DescriptionSalary: Hourly TBD Quality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The ValidationEngineer will evaluate the equipment/utility/system/procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the ValidationEngineermust be approved by the client. Responsibilities include: Interact with clients and works closely with site manufacturing, engineering, and QA to develop validation documents. Travel to various client sites and work independently to complete tasks. Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at client sites. Exposure to validation aspects of facility start-up, redesign/retrofit, and expansion. Writes and executes qualification protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards. Conducts temperature mapping studies, including the operation of Kaye dataloggers, or equivalent. Review and approve documented test results and maintain records for later analysis. Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems. Able to read P&IDs, isometric drawings, and As-built drawings. Skill Level and Requirements: Ability to problem solve and troubleshoot. Technical writing ability and use of Microsoft Word, Excel, Power point, and Project Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired. Experience using statistical tools is a plus to analyze data captured during validation studies. Minimum Requirements: BS in a technical discipline (Engineering, chemistry, microbiology, biology) 7+ years of experience in at least one of the following areas: equipment/utility qualifications, process validation, analytical method validation, or cleaning validation. Current drivers license and auto insurance Quality Agents offers a full suite of benefits for full-time employees including: Health, dental and vision insurance Life, AD&D and disability Insurance Health savings account for participants in our health plan 401k retirement plan Paid time off Paid holidays Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application.After that time, or if your application information changes, please submit your application again.

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

Your Role: This position is responsible for adhering to the validation program, maintaining and assuring compliance with the Validation Master Plan, lifecycle process and, regulatory requirements and Site policies. Essential Duties and Responsibilities: Draft and execute validation protocols (IQ, OQ, PQ, EMPQ, Aseptic Process Qualifications, etc.). Author validation and technical protocols, reports and develops project plans. Support validation and technical assessments for quality impact and participate on quality investigation teams. Monitor maintenance of the validated state of basic and some complex equipment and utilities via Validation Master Lists and processes. Act as an SME in client and regulatory audits, addresses audit findings, CAPAs and deviations. Generate, review, and assess validation final reports and addresses gaps as required. Conduct risk assessment, create FMEAs and other documents to justify the validation approach being taken Participate in change control evaluations and provides feedback on validation and/or calibration status impact. Perform routine gap analysis of the site's Validation and Calibration Programs to correct gaps as required. Manage and coordinate validation and calibration contractors to ensure the preservation of the equipment, process and facility's validated state. Create and revise SOPs related to the site's Validation and Calibration programs to maintain their accuracy and ensure best practices are being followed. Oversee computerized system validations. Responsible for all GMP documentation related to validation and calibration at the site activities. Requirements: Bachelor's degree in engineering (Mechanical, Electrical, Chemical) or a Scientific discipline (required); 0-2 years' experience related to validation and/or engineering in the pharmaceutical and/or biotech industry. Working knowledge of regulations (cGMP-FDA 21CFR 210/211, 600 and/or part 11 Eudralex Volume 4). Experience in the validation, commissioning and qualification or equipment systems is a plus. Skills: Microsoft office software Microsoft Project Cleaning Validation experience is a plus Knowledge: Visio is a plus Physical Demands: While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Working Environment: This position deals with temperature-controlled materials in which personal protective equipment (PPE) may be required due to extreme temperatures. Employees must wear appropriate clothing and protective equipment such as masks, glasses and gloves when entering the manufacturing and/or laboratory environment. The hiring range for this position is expected to fall between $72,200-$85,000/year reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions. Miltenyi Biotec North America is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity. Miltenyi Biotec, Inc participates in E-Verify. Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.

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

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

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