Sr. Mfg. & Process Engineer - Capgemini
Raritan, NJ
About the Job
Job description :
Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.
KEY RESPONSIBILITIES :
· DevelopmentModificationUpgradeEnhancement of MBR’s and GMBR’s on PAS-X V3 (V 3.1.8 or higher)
· 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 adherence to project timelines and budget constraints.
· Compliance: Ensure all automation processes comply with industry regulations, including GMP (Good Manufacturing Practices) and FDA guidelines.
· System Maintenance: Oversee the maintenance, troubleshooting, and optimization of Werum PAS-X systems to ensure maximum uptime and operational efficiency.
· Validation: Manage the validation and qualification processes for developed MBR’s, ensuring they meet user requirement 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 PAS-X systems.
· Continuous Improvement: Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.
Required Skills:
· Minimum of 5-7 years of experience in the pharmaceutical industry with a focus on MBR Development on Werum PAS-X systems.
· Bachelor’s degree in engineering, Computer Science, or a related field. Masters degree is a plus.
· Strong knowledge of GMP, FDA regulations, and industry best practices.
· Proficiency in Werum PAS-X and other pharmaceutical automation systems.
· Project management experience, with the ability to lead cross-functional teams.
· Excellent problem-solving skills and the ability to work effectively in a team-oriented environment.
· Strong communication and documentation skills.
· Ability to adapt to changing priorities and manage multiple tasks simultaneously.
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 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.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 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-law
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.
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: _Programmer/Analyst_
Organization: _ERD PPL US_
Title: _Sr. Mfg. & Process Engineer_
Location: _NJ-Raritan_
Requisition ID: _077572_
Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.
KEY RESPONSIBILITIES :
· DevelopmentModificationUpgradeEnhancement of MBR’s and GMBR’s on PAS-X V3 (V 3.1.8 or higher)
· 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 adherence to project timelines and budget constraints.
· Compliance: Ensure all automation processes comply with industry regulations, including GMP (Good Manufacturing Practices) and FDA guidelines.
· System Maintenance: Oversee the maintenance, troubleshooting, and optimization of Werum PAS-X systems to ensure maximum uptime and operational efficiency.
· Validation: Manage the validation and qualification processes for developed MBR’s, ensuring they meet user requirement 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 PAS-X systems.
· Continuous Improvement: Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.
Required Skills:
· Minimum of 5-7 years of experience in the pharmaceutical industry with a focus on MBR Development on Werum PAS-X systems.
· Bachelor’s degree in engineering, Computer Science, or a related field. Masters degree is a plus.
· Strong knowledge of GMP, FDA regulations, and industry best practices.
· Proficiency in Werum PAS-X and other pharmaceutical automation systems.
· Project management experience, with the ability to lead cross-functional teams.
· Excellent problem-solving skills and the ability to work effectively in a team-oriented environment.
· Strong communication and documentation skills.
· Ability to adapt to changing priorities and manage multiple tasks simultaneously.
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 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.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 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-law
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.
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: _Programmer/Analyst_
Organization: _ERD PPL US_
Title: _Sr. Mfg. & Process Engineer_
Location: _NJ-Raritan_
Requisition ID: _077572_
Source : Capgemini