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Title: Lead Validation Engineer

Location: Richmond VA

Duration: Full Time

Job Description:

Responsible for overseeing both manufacturing operations and the validation processes that ensure all systems, processes, and equipment are compliant with regulatory standards and are functioning optimally.

The role combines elements of operations management with a specific focus on validation, ensuring that all equipment, facilities, processes, and systems meet regulatory requirements and internal quality standards. It requires a deep understanding of manufacturing operations, validation methodologies, and regulatory requirements like GMP (Good Manufacturing Practices), FDA guidelines, ISO standards, and others.

Key Responsibilities:

• Established to ensure that all finished product is manufactured, packaged and labeled as intended, including conformance to applicable legal and regulatory requirements. Product requirements also relate to conformance to raw material, component, intermediate material, in-process requirement, and finished product attributes.

• Oversee the validation of manufacturing equipment, systems, and processes to ensure they meet regulatory requirements and are operating according to specifications.

• Lead the qualification of new equipment, ensuring that it is installed and operates within expected parameters. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Ensure that the manufacturing processes are validated according to regulatory guidelines, such as FDA 21 CFR Part 820, ISO 13485, or other relevant standards. This may involve process validation (PV) and re-validation when changes to processes or equipment are made.

• Oversee the validation of manufacturing software and IT systems, such as Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems, to ensure they function correctly and meet compliance requirements.

• Develop and implement validation plans, protocols, and reports, ensuring they are comprehensive, compliant, and executed correctly.

• Address any deviations or non-conformances identified during manufacturing or validation activities by initiating corrective and preventive actions (CAPA) and ensuring issues are properly investigated and resolved.

• Ensure that all validation documentation, including qualification protocols, validation reports, and SOPs, is properly maintained, reviewed, and stored in accordance with regulatory requirements.

• Collaborate closely with the quality assurance (QA) team to ensure that manufacturing operations and validation activities align with the company’s quality management systems (QMS).

• Work with the training department to ensure that manufacturing and validation teams are properly trained in procedures, equipment handling, and regulatory compliance.

• Lead and manage the manufacturing and validation teams, providing guidance, mentorship, and support to team members. Ensure that the teams are well-trained, motivated, and aligned with company goals.

Required Skills:

• A bachelor’s degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.

• 5-10 years of Quality / relevant process experience in regulatory environment

• Several years of experience in manufacturing operations and validation within regulated industries such as pharmaceuticals, medical devices, or food manufacturing.

• 3-8 years of people leadership

• Ability to lead and manage an onshore and offshore team

• Strong communication skills to interact with cross-functional teams, senior management, and external auditors or regulators.

• 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.

Job: Developer

Organization: ERD PPL US

Title: Lead Validation Engineer

Location: VA-Richmond

Requisition ID: 078230