Senior Compliance & CQV Engineer

Hovione•East Windsor, NJ

About The Position

You will be responsible to: Performs engineering and associated support activities in operations, production, construction or maintenance environments. Designs and installs processes, instruments and equipment and tests manufacturing facilities to meet quality, safety and productivity standards. Plans, designs and estimates time and cost and oversees construction and maintenance of structures, facilities, systems and components. Analyses and develops solutions to engineering problems related to manufacturing equipment and systems or the causes of component failures. Develops and applies engineering standards and procedures, guidelines and legal requirements and provides advice on issues within the engineering and maintenance field. Apply expertise in a scientific or highly technical area of specialty as an individual contributor or through contributing to/managing project teams in order to achieve results. Entry-level jobs typically require a university degree or equivalent work experience that provides knowledge of and exposure to fundamental theories, principles and practices. Contribute to the development and periodic revision of CQV standards, SOPs, and technical guidelines; take ownership of specific technical areas within the Body of Knowledge. Review new projects for compliance with internal standards and regulatory expectations; provide formal feedback and mentor project engineers on best practices. Act as a senior reference for CQV standards, supporting internal teams and external partners in consistent and effective implementation. Deliver expert guidance and technical support for resolving complex equipment/systems challenges, drawing on standards and past experiences to drive effective solutions. Lead readiness activities for regulatory inspections and internal/client audits , by ensuring standards are followed, deviations justified, and documentation ready. Mentor and coach junior and mid-level engineers in understanding the intent, structure, and practical use of the Body of Knowledge; promote a culture of technical excellence and regulatory compliance. Lead the CQV scope for engineering projects, including design, implementation, commissioning, and qualification phases. Own the development and execution of the CQV plan for projects, defining deliverables, timelines, resource needs, and risk mitigation strategies. Supervise and review work performed by junior engineers and outsourced partners; ensure adherence to company standards and project requirements. Drive effective coordination between engineering, validation, manufacturing, QA, and IT functions during project delivery. Actively contribute to the development of design documentation (e.g., URS, FDS, SDS, HMI philosophy) and participate in key milestone reviews. Lead planning and execution of commissioning and qualification , coordinating all testing and verification activities to ensure GMP compliance. Support or lead the handover process of equipment/systems to operations and maintenance, ensuring all qualification, documentation, and training requirements are fulfilled. We are looking to recruit a Candidate:

Requirements

University degree, or equivalent qualification in Engineering (Chemistry, Mechanical, Electrical, Electronics/Automation) or similar scientific field (mandatory)
5+ years of relevant experience in CQV including system design, implementation, and qualification (mandatory)
Strong understanding of validation, compliance (e.g., GAMP), and engineering project execution
Strong knowledge of legislation applicable to engineering projects and GMP compliance
Ability to respond to audits and represent the CQV scope during regulatory inspections
Fluent in written and spoken English
Must demonstrate ability to independently perform and document technical tasks in line with internal procedures and external regulations

Nice To Haves

Experience in chemical or pharmaceutical industry preferred
Proficient with MS Office and CAD tools; familiarity with version control and digital design tools preferred

Responsibilities

Contribute to the development and periodic revision of CQV standards, SOPs, and technical guidelines; take ownership of specific technical areas within the Body of Knowledge.
Review new projects for compliance with internal standards and regulatory expectations; provide formal feedback and mentor project engineers on best practices.
Act as a senior reference for CQV standards, supporting internal teams and external partners in consistent and effective implementation.
Deliver expert guidance and technical support for resolving complex equipment/systems challenges, drawing on standards and past experiences to drive effective solutions.
Lead readiness activities for regulatory inspections and internal/client audits , by ensuring standards are followed, deviations justified, and documentation ready.
Mentor and coach junior and mid-level engineers in understanding the intent, structure, and practical use of the Body of Knowledge; promote a culture of technical excellence and regulatory compliance.
Lead the CQV scope for engineering projects, including design, implementation, commissioning, and qualification phases.
Own the development and execution of the CQV plan for projects, defining deliverables, timelines, resource needs, and risk mitigation strategies.
Supervise and review work performed by junior engineers and outsourced partners; ensure adherence to company standards and project requirements.
Drive effective coordination between engineering, validation, manufacturing, QA, and IT functions during project delivery.
Actively contribute to the development of design documentation (e.g., URS, FDS, SDS, HMI philosophy) and participate in key milestone reviews.
Lead planning and execution of commissioning and qualification , coordinating all testing and verification activities to ensure GMP compliance.
Support or lead the handover process of equipment/systems to operations and maintenance, ensuring all qualification, documentation, and training requirements are fulfilled.