**Scientist - II (Multiple position)** **Duration: 12 Month Contract** **Location: Onsite - 126 E. Lincoln Avenue PO Box 2000, Rahway, NJ 07065** Our Fortune 500 client (One of the world's largest Pharmaceutical companies) in **Rahway, NJ** is looking for hardworking, motivated talent to join their innovative team. Are you a **Scientist - II** with a passion for collaborating with multiple teams and an interest in working onsite? Don't wait... apply today! **Must haves:** + **Analytical engineering** + **Mechanical testing expertise** + **Lab experiments experience** + **Familiar with test methods, Method development and method validation.** **Qualifications:** **Education Requirement (minimum):** + B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required. **Required Experience and Skills:** + **A minimum of M.S., or B.S. plus 1-3 years of design, engineering, and mechanical testing/test method development experience.** + **Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.** + Experience training junior staff on instrumentation operation and data analysis/interpretation best practices. + **Deep technical understanding of test method development and qualification/validation techniques.** + **Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.** + Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing. + **Experience in 3D CAD (e.g. SolidWorks), geometric tolerancing and stack-up analysis.** + Documents (following Good Documentation Practices) and analyze test cases and provide comprehensive feedback and recommendations for product or design changes. **Preferred Experience and Skills:** + Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex . Keyence / Cognex), Bouncer, and drop shape analyzers. + Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensure measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle. + Experience with medical device development with understanding of Design Controls (21 CFR 820.30) + Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use. + Additional familiarity/experience with the following industry related knowledge is a plus: + 21 CFR Part 4 + 21 CFR 211 + FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics + ISO 13485 + ISO 14971 + ISO 11040 + ISO 10993 **Responsibilities:** + Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our client has codified its legacy for over a century. + Our Client's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. + Our client is on a quest for cures and is committed to being the worlds premier, most research-intensive biopharmaceutical company. Today, they are doubling down on this goal. + Our client is a true scientific research facility of tomorrow and will take leading discovery capabilities and world-class small molecule, biologics, and vaccine R&D expertise to create breakthrough science that radically changes the way we approach disease treatment. + As part of their global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. **Scientist, Device and Combination Product Test** + Our Client's Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused Scientist focused on the characterization and testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products). + This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our client's pipeline to identify risks (i.e. when/why/how will the device fail) and opportunities for improvement. + They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the devices material and functional properties and attributes. + Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically though mechanical (i.e. compress/torsion spring, compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches. If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.