Senior Industrial Operations Engineer - MBR Analyst

　　Raritan, New Jersey

　　Key Responsibilities:

　　Development\Modification\Upgrade\Enhancement of MBR’s and GMBR’s on PAS-V2\V3 and Validation and UAT of MBR’s\GMR\ESP.

　　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.

　　System Maintenance: Provides authority over the maintenance, solving, and optimization of Werum PAS-X systems ensuring maximum uptime and operational efficiency.

　　Validation: Lead the validation and qualification processes for developed MBR’s, ensuring we meet user requirements and specification.

　　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 systems.

　　Continuous Improvement: See opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.

　　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.

　　Project management experience, with the ability to lead cross-functional teams and ability to adapt to changing priorities and manage multiple tasks simultaneously.

　　Excellent problem-solving skills as we work effectively in a team-oriented environment with strong communication and documentation skills.

　　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, we help clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist 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 igniting human energy through technology for an inclusive and balanced future. It is a responsible and diverse organization of over 360,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, motivated by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2022 global revenues of €22 billion.

　　Get the Future You Want | www.capgemini.com

　　Disclaimer

　　Capgemini 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 vital 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-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 by Capgemini.

　　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.

　　Job: Developer

　　Organization: ERD PPL US

　　Title: Senior Industrial Operations Engineer - MBR Analyst

　　Location: NJ-Raritan

　　Requisition ID: 074324