Job description:
Responsible for ensuring that manufacturing systems, processes, and equipment meet regulatory requirements, company standards, and quality specifications. Validation engineers ensure that all equipment, production processes, and facilities are capable of consistently producing high-quality tobacco products while complying with applicable regulations, such as those set by the Food and Drug Administration (FDA) or other relevant authorities.
The role of a Validation Engineer in tobacco manufacturing is multifaceted, combining knowledge of both engineering principles and regulatory compliance. They ensure that all aspects of the manufacturing process, from raw material handling to final product packaging, are validated for efficiency, safety, and regulatory adherence
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KEY RESPONSIBILITIES:
1.Ensure that all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that they function correctly and meet operational specifications.
2.Validate tobacco manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging.
3.Regularly revalidate equipment and processes when changes occur, such as new materials, changes in equipment, or regulatory updates.
4.Assess risks related to equipment, processes, and production areas that could affect product quality, safety, or compliance.
5.When risks are identified (e.g., equipment malfunctions or process deviations), implement corrective and preventive actions (CAPA) to address these issues and ensure the manufacturing process remains in compliance.
6.Write, review, and execute validation protocols for new equipment, systems, or processes, ensuring that all documentation meets regulatory and internal requirements.
7.Ensure that all validation documentation is properly archived and readily accessible for audits or regulatory inspections. This includes validation reports, test results, and any related corrective action reports.
8.Document any changes in manufacturing processes or equipment, ensuring that these changes undergo proper validation before implementation.
9.Provide training to production teams on new validated processes or equipment and on maintaining compliance with regulatory and quality standards.
Required Skills:
• A bachelor's degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
• 3-7 years of Quality / relevant process experience in regulatory environment
• Strong communication skills to interact with cross-functional teams, senior management, and external auditors or regulators.
• Familiarity with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems may be beneficial.
• Strong understanding of validation methodologies, including IQ/OQ/PQ protocols, risk assessments, and data analysis techniques.
• In-depth knowledge of tobacco industry regulations (e.g., Tobacco Control Act), as well as FDA and GMP guidelines
• End to end process understanding
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.