Life at CapgeminiCapgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer:
Flexible work
Healthcare including dental, vision, mental health, and well-being programs
Financial well-being programs such as 401(k) and Employee Share Ownership Plan
Paid time off and paid holidays
Paid parental leave
Family building benefits like adoption assistance, surrogacy, and cryopreservation
Social well-being benefits like subsidized back-up child/elder care and tutoring
Mentoring, coaching and learning programs
Employee Resource Groups
Disaster Relief
About Capgemini EngineeringWorld leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.Get the Future You Want | www.capgemini.comTitle: MBR Business Specialist/ModelerLocation: Raritan, NJ (hybrid)Duration: Full TimePosition Description:As a Sr MBR Business Specialist, you will play a critical role in ensuring the smooth functioning of pharmaceutical manufacturing operations. Your responsibilities will various tasks related to Master Batch Records (MBRs) throughout the product lifecycle. MBRs are essential documents that guide the production of pharmaceutical products, from raw material procurement to final packaging.As a Senior MES PAS-X MBR Modeler, you will play a substantial role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will lead the team and ensure compliance with industry standards and regulations while optimizing production processes.Key Responsibilities:
DevelopmentModificationUpgradeEnhancement of MBR’s and GMBR’s on PAS-V2V3 and Validation and UAT of MBR’sGMRESP.
Werum PAS-X Implementation: Design, configuration, and implementation of Werum PAS-X systems to ensure seamless integration with existing pharmaceutical manufacturing processes.
Project Leadership: Take charge of MBR Development, from inception to completion, ensuring we provide consistency to project timelines and budget constraints!
Compliance: Ensures all automation processes align with industry regulations, including GMP (Good Manufacturing Practices) and FDA guidelines.
Qualifications:
Proven experience of 5-8 years in the pharmaceutical industry with a focus on MBR Development on Werum PAS-X systems with a Bachelor’s degree in engineering, Computer Science, or a related field. Master’s degree is a plus.
Outstanding knowledge of GMP, FDA regulations, and industry standard methodologies with proficiency in Werum PAS-X and other pharmaceutical automation systems.
CSV with experience in IQ/OQ/PQ
DisclaimerCapgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-lawPlease be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.Job: InfrastructureOrganization: ERD PPL USTitle: MBR Business SpecialistLocation: NJ-RaritanRequisition ID: 075124
