Equipment validation specialist jobs near me - 47 jobs

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: * Validation Specialist for Packaging Equipment Qualifications: * Bachelor's Degree in Science or Engineering. * Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries. * Experience in biotech packaging equipment (Vial filling, Syringe Filling, Lyophilization, Isolators, and secondary packaging such as labelers, cartoner, serialization, inspection). * Must be fully bilingual (English / Spanish) with excellent oral skills. * Must be proficient using MS Windows and Microsoft Office applications. * Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. * Experience in Commissioning and Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. * SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). * Technical Writing skills and investigations processes. * Available to work extended hours, possibility of weekends and holidays.

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.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is a remote position with up to 75% travel for candidates in the Central or East Coast of the United States.** **Summary:** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing. **Primary Responsibilities:** + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations. + Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. + Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries. + Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Writes test cases to validate critical control points, user requirements, and functional designs. + Executes test cases as needed. + Prepares validation reports for distribution. + Ensures milestones and timelines are met on assigned projects. + Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: + Prepares validation equipment for use at the Donor Center and for evaluation upon return. + Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. + Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. + Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. + Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable. + Travels on-site up to 75% as needed to ensure timely validation completion within the Geo. **Knowledge, Skills, and Abilities:** + Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. + Excellent quantitative and analytical skills. + Excellent oral and written communication skills. + Strong critical thinking and problem solving skills. + Ability to identify errors and provide corrective action. + Ability to work with others in a team environment. + Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. **Education and Experience:** + Bachelor's degree. + Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. + Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands:** Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! \#BiomatUSA \#LI-KS1 \#LI-Remote Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 537178 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This is a remote position with up to 75% travel for Candidates on the West Coast of the United States. Summary: Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing. Primary Responsibilities: Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations. Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries. Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: Writes test cases to validate critical control points, user requirements, and functional designs. Executes test cases as needed. Prepares validation reports for distribution. Ensures milestones and timelines are met on assigned projects. Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: Prepares validation equipment for use at the Donor Center and for evaluation upon return. Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable. Travels on-site up to 75% as needed to ensure timely validation completion within the Geo. Knowledge, Skills, and Abilities: Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. Education and Experience: Bachelor's degree. Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : Home Office:[[cust_building]] Learn more about Grifols

MaineHealth Corporate Professional - Clinical MaineHealth is actively recruiting for a DRG Validation Specialist. This is a 100% remote opportunity. The DRG Validation Specialist job functions will include: * reviews codes to validate DRG assignment * appeals external audits * processes Cloudmed recommendations * resolves DRG matches between CDI and coding * answers coding questions * identifies opportunities for query composition improvement/compliance * identifies educational needs * creates educational materials Required Minimum Knowledge, Skills, and Abilities (KSAs) * Education: Associate's and/or Bachelor's Degree in Health Information Management or other science based degree such as Nursing required. * License/Certifications: Registered Health Information Technician (RHIT), Registered Health Information Administrator (RHIA), or Certified Coding Specialist (CCS) required. * Experience: Three years of experience as an inpatient coder at a large acute care or academic teaching facility required. * Additional Skills/Requirements Required: N/A * Additional Skills/Requirements Preferred: Advanced coding skills and knowledge of revenue cycle, billing systems, EPIC Electronic Health Record and 3M Encoder, ICD 10 training, Computer Assisted Coding software (CAC) In addition to the KSA's above, the successful candidate should also have the following skill sets: * Auditing experience * Strong oral and written communication skills * Critical thinking and strong organizational skills Additional Information With a career at any of the MaineHealth locations across Maine and New Hampshire, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the communities that surround it. We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.

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

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

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

JOB DESCRIPTION Watershed Security, is a Veteran Owned Small Business with over 20 years' Cybersecurity and Government Contracting experiencing. Watershed is looking for a Senior Navy Qualified Validator (NQV) to support the Naval Surface Warfare Center (NSWC) in Philadelphia, PA. The successful candidates will be responsible for reviewing and implementing Risk Management Framework (RMF) lifecycle documentation, ensuring the confidentiality, integrity, and availability (CIA) of systems, networks, and information. This position involves conducting risk and vulnerability assessments, ensuring proper accreditation procedures are followed, and documenting any non-compliance issues. REQUIRED QUALIFICATIONS Bachelor's degree in computer science, information technology, communications systems management, or an equivalent science, technology, engineering & mathematics (STEM) degree from an accredited college or university. Active Navy Qualified Validator Certification. Must have at least one of the following active certifications: CCNA Security, CySA+, GICPS, GSEC, Security+, CND, SSCP. Years of Experience: Ten (10) years' practical experience in a cybersecurity or A&A related field. Implementing and/or reviewing RMF lifecycle documentation Validating confidentiality, integrity, and availability of systems Conducting risk and vulnerability assessments Ensuring proper accreditation procedures are followed Documenting non-compliance issues Clearance Level: SECRET; US Citizen. Ability to possibly provide onsite support in Philadelphia PA. Some/all remote work may be an option, however the norm will be onsite support. This will be dependent upon customer needs and classification level of work being performed. Some travel may be required. Experience with the Navy RMF Process Guide (RPG), and Navy A&A tools such as ACAS, eMASS and eMASSter. Proficient with Microsoft Office Suite (Word, Excel, Teams, Project). Self Starter; detail oriented; able to brief senior level staff. DESIRED QUALIFICATIONS Validation of 10 or more Navy Packages Experience with the NAVSEA RMF Business Rules Contingent upon award PAY RANGE Final salary is influenced by factors such as location, contract labor categories, experience, skills, education, and certifications. Watershed offers competitive compensation, medical and dental benefits, educational reimbursement, 401K plans with matching, 15 days of PTO to start and 11 paid holidays per year. The proposed salary range for this position is: $100,000 - $130,000 USD. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans Powered by JazzHR h7KJOo4Y9h

Who is Blueprint? We are a technology solutions firm headquartered in Bellevue, Washington, with a strong presence across the United States. Unified by a shared passion for solving complicated problems, our people are our greatest asset. We use technology as a tool to bridge the gap between strategy and execution, powered by the knowledge, skills, and the expertise of our teams, who all have unique perspectives and years of experience across multiple industries. We're bold, smart, agile, and fun. What does Blueprint do? Blueprint helps organizations unlock value from existing assets by leveraging cutting-edge technology to create additional revenue streams and new lines of business. We connect strategy, business solutions, products, and services to transform and grow companies. Why Blueprint? At Blueprint, we believe in the power of possibility and are passionate about bringing it to life. Whether you join our bustling product division, our multifaceted services team or you want to grow your career in human resources, your ability to make an impact is amplified when you join one of our teams. You'll focus on solving unique business problems while gaining hands-on experience with the world's best technology. We believe in unique perspectives and build teams of people with diverse skillsets and backgrounds. At Blueprint, you'll have the opportunity to work with multiple clients and teams, such as data science and product development, all while learning, growing, and developing new solutions. We guarantee you won't find a better place to work and thrive than at Blueprint. In This Role In this role, you will own the health and reliability signals for modern media codecs used at massive scale. You will design and expand telemetry across video and image codec pipelines, analyze real-world data to uncover reliability gaps, and make issues visible through clear, actionable dashboards. You will also strengthen hardware validation by extending encoder test coverage and integrating advanced validation scenarios into certification workflows. Day-to-day, you will collaborate with codec engineers, validation teams, and hardware partners to close coverage gaps, reduce failures, and ensure high-quality media experiences ship reliably across devices. Responsibilities Design, implement, and expand telemetry events, schemas, and probes across video and image codec pipelines. Increase telemetry depth for advanced codec profiles, color formats, and configuration variations. Define and track reliability metrics, performance indicators, and failure signals across encode and decode paths. Analyze large-scale telemetry and validation data to identify trends, regressions, and rare or profile-specific issues. Build and enhance dashboards that surface actionable health insights for engineering and validation teams. Author, extend, and maintain hardware validation tests for video encoders, including support for modern codecs. Expand encoder test coverage beyond basic bitstream validation to include functional correctness, feature enablement, and reliability scenarios. Integrate advanced hardware validation scenarios into certification workflows to reduce partner failures and friction. Collaborate closely with codec engineers, validation teams, and hardware partners to close gaps in coverage and compliance. Drive improvements that measurably increase codec reliability, driver readiness, and ecosystem quality. Required Qualifications 4-6+ years of codec and media pipeline experience, working with modern video/image codecs (e.g., H.264, HEVC, AV1 or equivalent). Strong understanding of codec internals, including encode and decode paths, profile variations, color formats (8-bit / 10-bit, 4:2:0 / 4:2:2 / 4:4:4), and common failure modes. 3-5 years of experience developing video or hardware validation tests on real hardware (GPU, SoC, or accelerator). Hands-on experience validating codec features, hardware enablement, correctness, and performance behavior. 4+ years of telemetry or observability engineering experience, including defining events, metrics, instrumentation, and dashboards. Proven ability to analyze large datasets to identify root causes, reliability gaps, and regression patterns. Strong problem-solving skills with the ability to translate ambiguous signals into concrete engineering actions. Experience collaborating across engineering, validation, and partner teams. Preferred Qualifications Experience with hardware certification or validation workflows for drivers or system components. Prior exposure to integrating advanced validation suites into broader test or certification pipelines. Experience working directly with hardware partners or external vendors to improve compliance and pass rates. Familiarity with large-scale telemetry systems used in production environments. Background in building or operating quality, reliability, or health dashboards used for release decisions. Ability to influence cross-team technical decisions through data, documentation, and clear communication. Salary Range At Blueprint, we strive to offer competitive pay that reflects the value of our team members. Compensation for this role is influenced by a variety of factors, including skills, education, responsibilities, experience, and geographic market. For candidates based in Washington State, the anticipated salary range is $120,000 to $140,000 USD/Year. Please note that we typically do not hire new employees at the top of the posted range. Actual starting pay will be determined based on experience, skills, and internal equity. The final salary and job title may vary depending on the selected candidate's qualifications and could fall outside the stated range. Equal Opportunity Employer Blueprint Technologies, LLC is an equal employment opportunity employer. Qualified applicants are considered without regard to race, color, age, disability, sex, gender identity or expression, orientation, veteran/military status, religion, national origin, ancestry, marital, or familial status, genetic information, citizenship, or any other status protected by law. If you need assistance or a reasonable accommodation to complete the application process, please reach out to: ******************* Blueprint believe in the importance of a healthy and happy team, which is why our comprehensive benefits package includes: Medical, dental, and vision coverage Flexible Spending Account 401k program Competitive PTO offerings Parental Leave Opportunities for professional growth and development Location: Remote

Are You Ready?CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. Our Foundational Principles- At CAI, we are committed to living our values-both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future- We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done. Key Responsibilities1. Technical Responsibilities- Develop documentation for CQV activities- Write and execute protocols (field verification)- Develop summary reports at client sites2. Areas of Focus- Pharmaceutical facilities- Utilities- Equipment3. Project & Team Management- Plan and coordinate work- Direct small teams in document development and/or execution Qualifications and Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 2-4 years' experience in commissioning and qualification in a regulated industry- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus- Preferred experience in:- Facilities and equipment startup- Walk-downs and troubleshooting- Utilities (WFI, RO, HVAC)- Upstream/downstream processing- Purification, recovery- Building automation- Pharmaceutical manufacturing processes Critical CompetenciesInfluence Strategy- Pursues initiatives aligned with organizational strategy- Identifies strategic, innovative solutions- Anticipates emerging customer/market needs Satisfy the Customer- Understands and anticipates customer needs- Delivers high-quality solutions and service- Proactively maintains satisfaction and loyalty Plan for Success- Aligns business strategies with actionable plans- Anticipates risks and builds contingency plans- Secures resources for goal achievement Pursue Execution- Prioritizes time and resources effectively- Holds self and others accountable- Acts to overcome obstacles and improve quality Tailor Communication- Communicates clearly and professionally- Adjusts style to fit the audience- Explains technical concepts effectively Build Partnerships- Builds networks across functions- Encourages collaboration and breaks down silos- Involves stakeholders in decisions Influence Others- Builds support with sound rationale- Gains buy-in from decision makers- Encourages innovative thinking Develop Self and Others- Enhances interpersonal relationships- Models integrity and company values- Seeks out growth and breakthrough opportunities#LI-MV1Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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

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

Ishpi Information Technologies, Inc. (DBA ISHPI) is passionate about providing our customers with technical solutions that satisfy their business needs. Through collaborative interactions with customers, team members, subject matter experts (SMEs), technical leaders, and partners we design practical solutions that solve real problems for major government and business organizations. As a member of our group, you will work with a team focused on delivering innovative business solutions using emerging technologies through proven successful methods. Responsibilities The Fully Qualified Navy Validator III will provide support to the Naval Surface Warfare Command in Philadelphia, PA. Shall assist with the preparation and submission of all RMF A&A and AO packages. All RMF activities shall follow the most current applicabledocuments including DON RMF Process Guide, DoD Instruction 8510.01, and the business rules of cognizant review offices for each package. Shall also produce and maintain RMF artifacts related to the authorization or de-authorization of assigned RMF packages, applications, and systems under the cognizance of NSWCPD. Qualifications Education: Requires a Bachelor's degree in Computer Science from an accredited university. Work Experience: Ten (10) years of professional experience. Experienced in the management of IAT, certification agents and system engineers on the compliance requirements to achieve certification and accreditation IAW the DoD RMF program and the Department of Navy (DON) Chief Information Officer (CIO) IA Policy for PIT Systems. Ten (10) years of support to the DON or DoD, preferably as an IAM, Certification Agent and/or Designated Approval Authority and Certification Authority staff. Certifications: Fully Qualified Navy Validator certificate. IAM Level II certification. Security Clearance: Requires U.S. Citizenship and an active government security clearance. “Ishpi Information Technologies, Inc. is an Equal Opportunity Employer. All qualified candidates will be considered without regard to legally protected characteristics. Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified, you may be contacted for this and future openings.

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

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

Job Description : A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit *********************** POSITION OVERVIEW: We are seeking a Validation Lead with 5-10 years of experience. The ideal candidate will have hands-on startup and commissioning experience with building and utility systems, as well as experience in generating and managing engineering lifecycle documentation. 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.) Lead and execute startup, commissioning and validation of building and utility systems, process equipment, and/or laboratory instrumentation. Generate and manage engineering lifecycle documentation, including impact assessments, URS/FRS, FAT/SAT documentation, ETOPs, P&IDs, and other technical documents. Conduct drawing walkdowns and verify field installation of equipment and utilities. Generate and execute protocols and reports. Collaborate with cross-functional teams to ensure successful project completion. Communicate effectively with stakeholders to provide updates and address issues. Ensure compliance with safety standards and regulations. 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 or a related field. Technical Experience : 7-10 years of hands-on equipment startup and validation experience. Experience with generating and managing engineering lifecycle documentation. Experience with drawing walkdowns and verification of field installation. Experience with BMS, PCS, and CMMS systems. Experience with continuous manufacturing processes is desired Experience with PAT and process controls and instrumentation is desired Knowledge, Skills, and Abilities : Strong understanding of validation lifecycle for equipment and utilities Excellent documentation and organizational skills. Ability to work independently and as part of a team. Strong communication and interpersonal skills. Detail-oriented with strong problem-solving abilities. ESSENTIAL FUNCTIONS: Physical Demands : The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit *********************************** About the Role: We are seeking a detail-oriented and compliance-focused Pharmaceutical Validation Engineer to support validation activities across sterile and non-sterile compounding operations in our 503A and 503B pharmacy facilities. The ideal candidate will be responsible for ensuring that all systems, equipment, processes, and environments perform reliably and consistently according to regulatory and operational standards. This role requires hands-on experience with commissioning and qualification (CQV), process and cleaning validation, and equipment/system lifecycle documentation in accordance with cGMP, USP , , , and FDA 21 CFR Part 210/211 standards. The candidate will collaborate cross-functionally with pharmacy operations, quality, engineering, and IT teams to maintain regulatory compliance and validation readiness. You Will:Validation Development & Execution Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for cleanrooms, HVAC systems, compounding equipment, and critical support systems. Create validation master plans, risk assessments (e.g., FMEA), traceability matrices, and standard protocol documentation. Validation Activities & Data Analysis Perform validation testing including equipment calibration, challenge studies, and environmental monitoring qualification. Analyze validation data to verify compliance and identify trends or deviations; recommend corrective actions and process improvements. Documentation & Regulatory Compliance Prepare and maintain detailed validation reports, change control documentation, and CAPA records in compliance with cGMP and internal SOPs. Support audits and inspections by maintaining audit-ready documentation and presenting technical validation data. Commissioning & Qualification (CQV) Execute CQV for pharmaceutical equipment, utilities (e.g., purified water, steam, compressed air), and facility systems to ensure readiness for commercial use. Review vendor documentation and FAT/SAT results to support qualification efforts by coordinating with various vendors on a day to day basis and attending vendor FATs. Process, Cleaning, and Computer System Validation Conduct process validation for sterile and non-sterile compounding workflows, ensuring consistent performance within defined parameters. Perform cleaning validation to demonstrate removal of active pharmaceutical ingredients and contaminants from compounding equipment. Support computer system validation (CSV) activities to ensure electronic systems meet 21 CFR Part 11 compliance. Cross-functional Collaboration Collaborate with engineering, QA/QC, manufacturing, and IT teams to integrate new systems, troubleshoot issues, and ensure compliant implementations. Train pharmacy and operations staff on validated systems and procedures. Continuous Improvement Participate in continuous improvement initiatives by evaluating validation gaps and identifying opportunities for process and documentation enhancements. Support efforts to maintain and improve environmental controls, pressure differential systems, HEPA filtration, and sterility assurance. You Have: Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical, Industrial, or related field) or a science-based discipline. 5+ years of experience in validation, quality assurance, or regulated pharmaceutical manufacturing, preferably in compounding environments. Working knowledge of USP , , , cGMP, and FDA 21 CFR Part 210/211 regulations. Experience in creating, executing and documenting IQ/OQ/PQ protocols, risk assessments, and change control procedures. Familiarity with validation of utilities, cleanrooms, automation systems, and computer systems used in manufacturing and compounding. Proficiency in Microsoft Office Suite, AutoCAD, and documentation systems such as Veeva, MasterControl, or equivalent. Strong analytical, organizational, and problem-solving skills with attention to technical accuracy and regulatory compliance. Excellent written and verbal communication skills with the ability to interact across cross-functional teams. Demonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems. Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams. Strong written and verbal communication skills, including proficiency with Microsoft Office tools (Excel, Word, PowerPoint); experience with Smartsheet, Jira, or similar platforms is a bonus. Willingness to travel as required to equipment FATs, vendor sites etc. Our Benefits (there are more but here are some highlights): Competitive salary & equity compensation for full-time roles Unlimited PTO, company holidays, and quarterly mental health days Comprehensive health benefits including medical, dental & vision, and parental leave Employee Stock Purchase Program (ESPP) 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

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