Overview: 

We are seeking a highly skilled and experienced Senior Quality and Validation Engineer to lead and deliver high-quality validation strategies and quality systems for bespoke automated equipment used in FDA-regulated manufacturing environments. Reporting to the QAV manager, this senior role combines technical expertise, leadership, and a customer-centric mindset to ensure best-in-class outcomes across complex, high-tech projects.

You will be responsible for overseeing validation lifecycle activities, maintaining compliance with regulatory standards, developing quality objectives aligned with business goals, and leading a high-performing team of engineers. This is a customer-facing role, requiring strong communication skills and the ability to develop and maintain strategic partnerships. 

Key Responsibilities: 

Validation Strategy & Execution

• Define, develop, and deliver robust validation packages in compliance with GAMP, GMP/GEP, and customer-specific requirements.
• Develop and approve key validation documents: VPP, SRM, FDS, HDS, SDS, RTM, FMEA, FAT, SAT, and validation summary reports.
• Act as lead validation contact for project teams and customers, ensuring clear communication of validation strategy, scope, and deliverables.
• Coordinate risk management activities and support issue resolution related to discrepancies and deviations. 

Quality Assurance & Continuous Improvement

• Contribute to the development and implementation of quality policies, procedures, and standards to ensure operational excellence.
• Ensure quality best practices and quality culture are maintained across the company.
• Drive continuous improvement initiatives to optimize operational efficiency, reduce business risk, and enhance quality.
• Lead internal audits and external as required. 

Customer & Stakeholder Engagement

• Interface directly with customers throughout the validation lifecycle—from requirements gathering through final project delivery.
• Develop and maintain long-term customer relationships to support repeat business and industry reputation.
• Communicate schedule risks, project status, and validation outcomes effectively to both internal and external stakeholders.
• Interface with Customers directly to investigate and close out any customer related quality issues.
• Collaborate across internal stakeholders to lead and investigate root-cause analyses relating to any internal quality issues. 

Qualifications & Experience: 

·        Bachelor’s degree in Science, Engineering, or a related technical discipline.

·        Minimum 5 years’ experience in validation and/or quality roles within regulated environments (pharma, medical device, or similar).

·        Demonstrated experience leading or mentoring engineering teams.

·        Proven track record in delivering complex validation strategies and managing full project documentation lifecycle. 

Key Skills & Abilities: 

·        Strong understanding of GAMP, GMP/GEP, and life sciences regulatory landscape.

·        High attention to detail with excellent documentation skills.

·        Strong analytical and risk management abilities.

·        Excellent interpersonal, communication, and stakeholder engagement skills.

·        Team-oriented with leadership capabilities and a customer-focused mindset.

·        Proactive, structured, and solutions-driven work style.

·        Proficiency in MS Office Suite (Word, Excel, PowerPoint, Project). 

Desirable:

·        Knowledge of 21 CFR Part 11, ER/ES, and data integrity guidelines.

·        Familiarity with automation systems, including Allen Bradley PLCs, FactoryTalk View, databases, and SQL server testing. 

What we offer: 

In AIR, we offer a comprehensive benefits package to support our employees' well-being and professional development, including flexible work arrangements, health insurance contributions, company bonus, maternity and paternity leave, pension plan, training support, and various wellness initiatives. 

About AIR: 

Established in 2023, Automated Industrial Robotics Inc from Los Angeles, USA and funded by ARES Management private equity group, AIR is a trusted automation partner empowering our customers to innovate, produce and scale through technology-enabled manufacturing. Our five-hundred-person world-class team operates across 350,000 sq ft of advanced manufacturing space in four facilities spanning America and Europe. With centralized engineering, technology and support, we deliver transformative automation solutions that increase quality, production and efficiency.

This job description is intended as a summary of the primary responsibilities and qualifications for this position. It is not exhaustive and may be subject to change. AIR is an Equal Opportunities Employer