Validation Engineer
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Job Description
About the job you’re considering
We are seeking an experienced Intermediate – CSV Validation Engineer with strong hands-on expertise in IQ/OQ/PQ protocol development, execution, and reporting to join our dynamic team. In this role, you will be responsible for ensuring that manufacturing systems, processes, and equipment comply with regulatory requirements, internal standards, and quality specifications. The Validation Engineer plays a critical role in confirming that equipment, production processes, and facilities consistently deliver high-quality products while meeting applicable regulatory requirements, including FDA and other relevant authorities
Your role
- 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.
- Validate manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging.
- Regularly revalidate equipment and processes when changes occur, such as new materials, changes in equipment, or regulatory updates.
- Assess risks related to equipment, processes, and production areas that could affect product quality, safety, or compliance.
- 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.
- Write, review, and execute validation protocols for new equipment, systems, or processes, ensuring that all documentation meets regulatory and internal requirements.
- 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.
- Document any changes in manufacturing processes or equipment, ensuring that these changes undergo proper validation before implementation.
- Provide training to production teams on new validated processes or equipment and on maintaining compliance with regulatory and quality standards.
Your skills and experience
- 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 Food/Consumer industry regulations, as well as FDA and GMP guidelines. Ability to lead and manage an onshore and offshore team
The base compensation range for this role in the posted location is: 51,900 - 103,000
Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.
The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.
These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.
It is not typical for candidates to be hired at or near the top of the posted compensation range.
In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini’s discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.
Disclaimers
Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. 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 accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation 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 in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Capgemini is 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.
Nashville, TN, US
Nearest Major Market: Nashville