Validation Engineer
$85.88k - $116.19kAmgen Inc
Career Category Operations Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Validation Engineer What you will do Let’s do this. Let’s change the world. In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions (NPI), product re-introductions (PRI) to Amgen Rhode Island’s Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI’s product portfolio. The schedule for this position is Monday – Friday Admin Day Shift. Responsibilities Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities, including validation planning, protocol development and execution, performance qualification, equipment release, and lifecycle documentation. Plan and coordinate and execute equipment and system qualification activities across a range of technologies, including CIP, SIP and autoclave systems, airflow visualization studies, benchtop equipment, and supporting utilities. Apply appropriate risk- and science-based approaches based on the system and intended use. Serve as the validation technical expert during project planning, equipment implementation, design reviews, and change control. Interpret engineering, automation, process, and equipment design documentation to determine validation requirements and appropriate testing approaches in accordance with established procedures and standards. Develop/author Validation plans Generate, review, and approve validation documentation and provide validation impact assessments for changes, projects, and equipment modifications. Investigate technical issues and develop solutions to validation challenges of moderate complexity. Execute and support cleaning validation and continued cleaning verification activities. Maintain site cleaning acceptance criteria, including calculating maximum allowable carryover (MAC) and providing scientific justification for acceptance criteria. Drive continuous improvement of validation programs, procedures, and execution practices, and develop or deliver training to manufacturing staff in support of validation activities. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The adaptable professional we seek is a self-starter with these qualifications. Basic Qualifications High school diploma / GED and 8 years of Manufacturing and Operations experience Associate’s degree and 6 years of Manufacturing and Operations experience Bachelor’s degree and 2 years of Manufacturing and Operations experience Master’s degree Preferred Qualifications Experience working in a GMP pharmaceutical or biotechnology manufacturing environment, with exposure to upstream and/or downstream operations. Hands‑on validation experience with manufacturing equipment, facility systems, and utilities, including equipment qualification, sterilization/steaming, cleaning validation, and performance studies. Strong technical understanding of pharmaceutical/biotechnology unit operations and manufacturing equipment and processes. Ability to interpret engineering and automation documentation and translate equipment and process requirements into appropriate validation testing. Strong understanding of GMP requirements and applicable CFR/regulatory expectations, with the ability to interpret and apply regulatory principles to validation activities. Strong analytical and experimental design skills, with the ability to evaluate validation data and resolve technical issues. Strong technical writing skills, with the ability to prepare clear, accurate, and compliant validation documentation. Strong verbal communication and project coordination skills, with the ability to work effectively across manufacturing, engineering, automation, and quality functions. Ability to work independently under general direction, manage priorities, and recognize when additional technical or management direction is appropriate. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Salary Range 85,878.05USD -116,187.95 USD Sponsorship Sponsorship for this role is not guaranteed. In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit and follow us on #J-18808-Ljbffr
- ...JPMorganChase is seeking a Principal Software Engineer to own LLM inference performance and optimization for scalable AI platforms. You will benchmark, quantify improvements, and drive decisions with leaders to improve speed, cost efficiency, and production readiness...Suggested
- ...We are seeking a Mechanical Product Validation Engineer with hands‑on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. The ideal candidate will support product development by developing and executing validation studies, creating...Suggested
$40 per hour
...Validation Engineer (Contractor)We are seeking a Validation Engineer with 4–7 years of relevant experience to support validation activities in a pharmaceutical/biotech environment. This role will involve qualifying and maintaining equipment and systems in compliance with...SuggestedHourly payFor contractors- ...believe there''s a fit worth exploring. I came across your profile, and something stood out. Responsibilities Lead and execute Process Validations and Test Method Validations for single use medical devices. Develop validation protocols, define critical parameters, execute...Suggested
$82.7k - $137.9k
## Senior Validation Engineer申请locations: United States - Michigan - Rochestertime type: 全职posted on: 今天发布job requisition id: 4961299**Use Your Power for Purpose**Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients...SuggestedPermanent employmentTemporary workH1bLocal areaVisa sponsorshipWork visaRelocation packageFlexible hoursShift workNight shiftAfternoon shift- ...innovative, secure solutions that provide speed to market and business value. The opportunity As an Attack Surface Validation & Exposure Engineer in the Attack Surface Management function, you will serve as a strategic contributor within EY’s Vulnerability...
$104.8k - $192.2k
...wherever you want it to go. Join EY and help to build a better working world. We are seeking an experienced Identity Verification Engineer with hands-on expertise in 1Kosmos or Microsoft Verified ID Identity Platform , identity proofing, passwordless authentication,...For contractorsSummer holidayFlexible hours- ...Microchip Technology Inc in Chandler, AZ is seeking an experienced Verification Engineer for our FPGA/SoC focus. You will work on verification of next‑generation, secure, low‑power FPGA device products, employing constrained random, formal, and C based verification methods...
- ...parts and machining optimization projects are completed by the required deadline, at a reasonable cost, and with a robust process to engineered tolerances. Acts as a liaison with the Engineering department to ensure effective resolution of issues as they relate to...
$105k - $130k
...Manufacturing EngineerThea Energy is leveraging recent breakthroughs in stellarator physics and engineering to create a faster and simpler approach to commercializing fusion energy. The company is reinventing the stellarator using computer-controlled arrays of planar coils...Night shiftWeekend work$21 - $25 per hour
...Fusion Energy EngineerThea Energy is leveraging recent breakthroughs in stellarator physics and engineering to create a faster and simpler approach to commercializing fusion energy. The company is reinventing the stellarator using computer-controlled arrays of planar coils...Internship- ...aligning manufacturing to program milestones and cost targets. The role requires strong Lean expertise, a proactive leadership style, and ability to collaborate across Engineering, Quality, Operations, and Supply Chain to optimize production performance. #J-18808-Ljbffr...
$80k - $100k
Job TitleLocation 131-40 Maple Ave., Flushing, NY, 11355, United StatesBase Pay $80,000.00 - $100,000.00 / YearEmployee Type Full Time- SalariedRequired Degree 4 Year DegreeManage Others NoMinimum Experience 3 YearsMaximum Experience 7 YearsJob DescriptionDescription ...Full time- ...Job Title Transform testing into a continuous and efficient end-to-end quality engineering function by leveraging quality processes, tools, and methodologies to significantly improve control, accuracy, and integrity. Develop more predictive and intelligent testing...
- ...Request-ID: 29564-1 Murex MXTest Test Automation Engineer (JD & Title updated 2.23) Onsite/ Hybrid - Jersey City, NJ Client... ...4. Murex MxTest API Insertions, GUI Insertions and OSP Validations 5. Good knowledge of Pre-Trade Rules, MxML Exchange and various...Full time
$89k - $133k
Position SummaryThe Industrial Engineer position supports the Manager in working with operational teams to improve processes in order to drive higher operational efficiency. The Engineer applies advanced analytical, statistical, modeling, simulation, and process improvement...Temporary workWork experience placementWork at officeImmediate startFlexible hoursNight shift- ..., development, and implementation and use of models. Per the Federal Reserve Supervision and Regulator guidance (SR 11-7), Model Validation is the set of processes and activities intended to verify that models are performing as expected, in line with their design objectives...Remote workFlexible hours
$95k - $105k
...equipment. Mini-Circuits’ sells its products to over 20,000 customers globally through our direct sales force, applications engineering staff, sales representatives, as well as through our extensive website. Position Summary: The Development Test Engineer II...Permanent employmentFull timeWork experience placement- ...Responsibilities Partner with product, engineering, and business teams to understand requirements and support planning and scoping.... ...automated testing frameworks and practices. Create, manage, and validate test data sets and analyze results. Incorporate...Full timeWork at officeShift workNight shiftWeekend workAfternoon shift
$75.75k - $101k
...Manufacturing Process EngineerThe Manufacturing Process Engineer is responsible for leading the measurement and analysis of warehouse inventory processes, developing standard operating procedures, and implementing continuous improvement projects. The Manufacturing Engineer...Permanent employmentFor contractorsWork at officeLocal areaFlexible hours- ...industry (aerospace, nuclear, etc.)Minimum technical background (engineering/science degree or experience), laser welding experience... ...documentation, including control plans, process instructions, validation protocols/reports, and engineering change ordersExecute validation...
- Southern Ohio Cleanup Company LLC seeks a Nuclear Criticality Safety professional to support and oversee safe handling of fissile/fissionable materials. You will review procedures, assess facilities, and assist management in maintaining compliance with safety standards...
$95k - $160k
...is leveraging recent breakthroughs in stellarator physics and engineering to create a faster and simpler approach to commercializing... ...high-impact engineering role with hands-on prototyping, testbed validation, and cross-functional collaboration with embedded systems and...Night shiftWeekend work- ...pluridisciplinary consulting firm focused on sustainable innovation. Our Sustainable Real Estate team applies a strong foundation in engineering and technology to high-performance building design, retrofit, and operations. We are a focused team of engineers and consultants...Full timeWorldwideOverseas
- ...Manufacturing Engineering TechnicianLee Spring manufactures and distributes mechanical springs, wire forms, stampings and fourslide parts worldwide. We offer an extensive product line of more than 25,000 inventoried products in a variety of materials available in stock...Worldwide
$123k - $163k
...Salary: $123,000 - 163,000 per year Requirements: We need at least 5 years of experience in software testing, automation engineering, or software development. We are looking for strong hands-on experience creating automation frameworks and testing solutions....Hourly payFull time- ...teams to ensure testing coverage and quality standards. Required Skills: - 5+ years in software testing, automation engineering, or software development. - Proven experience building automation frameworks and testing solutions. - Proficiency in Java,...Remote work
- OverviewThe Infosys Communications, Media, and Technology (CMT) unit is a dynamic and innovative division dedicated to driving digital transformation and growth for clients in the telecommunications, media, and technology sectors. Our vision is to become the strategic and...Full timeTemporary workRelocation
- ...Strobe's Distributed Power Plant Engineering Role Strobe is building the world's largest power plant: not a single site, but a distributed fleet of buildings, batteries, EVs, and generators that buy and sell power in real time across wholesale energy markets. Own...
$59.15k - $106.93k
...your career is good business. Leidos is seeking Distribution Engineers & Designers in New Jersey who are passionate about electric... ...in developing work packages ~ Candidates should possess valid U.S. driver's license, as some local or regional travel is expected...Work at officeLocal areaImmediate startRemote workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Validation Engineer. Be the first to apply!
- validation engineer Brooklyn, NY
- senior design verification engineer Brooklyn, NY
- validation consultant Brooklyn, NY
- validation specialist Brooklyn, NY
- verification & validation engineer Brooklyn, NY
- computer system validation engineer Brooklyn, NY
- verification engineer Brooklyn, NY
- medical device validation engineer
- entry level validation engineer
- system verification engineer



