Digital Engineer - MES Automation Validation Engineer at Capgemini Portugal

Raritan, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

0.0

Posted On

19 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

MBR Development, Werum PAS-X, Control Systems, Validation Process, GMP, FDA Regulations, Parameter Master Batch Records, Parameter Value Language, Documentation, Training, Continuous Improvement, Troubleshooting, Process Optimization, Automation Systems, Pharmaceutical Industry, SOPs

Industry

IT Services and IT Consulting

Description

About the job you’re considering As a MBR Designer Modeler PAS-X you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V3 (formerly Korber PAS-X) with knowledge of Control Systems and experience with Validation process. You will ensure compliance with industry standards and regulations while optimizing production processes. Your role Development/Modification/Upgrade/Enhancement of MBRs and GMBRs on PAS-X V3 (V 3.1 or higher) Werum PAS-X Implementation: Design, configuration, and implementation of Werum PAS-X systems to ensure seamless integration with existing pharmaceutical manufacturing processes. System Maintenance: Oversee the maintenance, troubleshooting, and optimization of Werum PAS-X systems to ensure maximum uptime and operational efficiency. Compliance: Ensure all automation processes comply with industry regulations, including GMPs (Good Manufacturing Practices) and FDA guidelines. Documentation: Maintain comprehensive documentation of automation processes, including SOPs (Standard Operating Procedures) and change control documentation. Training: Provide training and support to colleagues and team members to ensure their proficiency in Werum PAS-X systems. Continuous Improvement: Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions. Your skills and experience Must have 7-10 years of experience on MBR Development withing the Pharmaceutical Industry. Must have 7-10 years of experience with Werum PAS-X (formerly Korber PAS-X) and other pharmaceutical automation systems. Must have knowledge of PMBR (Parameter Master Batch Records) and PVL (Parameter Value Language) Must have Strong knowledge of GMP, FDA regulations, and industry best practices. Ability to adapt to changing priorities and manage multiple tasks simultaneously. Must have Bachelor’s degree in engineering, Computer Science, or a related field. Masters degree is a plus. Life at Capgemini Capgemini 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 Engineering World 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 65,000 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 business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. 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, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of €22.1 billion. Get the future you want | www.capgemini.com Disclaimer Capgemini is an Equal Opportunity Employer encouraging inclusion 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. Please 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. Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law 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.

Responsibilities

The role involves the development, modification, and enhancement of MBRs and GMBRs on PAS-X V3, ensuring compliance with industry standards. Additionally, the engineer will oversee system maintenance and provide training to colleagues.