Validation Engineer
Overview
We are seeking a highly skilled Validation Engineer to develop and deliver validation packages for bespoke automated equipment within a fast-paced, high-technology automation company. This role focuses on supporting FDA-regulated manufacturing customers by ensuring compliance with validation standards throughout all project stages, from proposal to final delivery. The Validation Engineer will define validation strategies, plan project documentation, and execute validation activities in alignment with project objectives while optimising cost efficiency.
This position requires in-depth knowledge of GAMP requirements and a strong understanding of the software system development lifecycle for automated equipment. Additionally, it is a customer-facing role responsible for meeting customer requirements and fostering key customer relationships.
Key Responsibilities
- Develop, review, and approve Validation Project Plans (VPP).
- Develop and review User Requirements Specifications (URS), Functional Design Specifications (FDS), Hardware Design Specifications (HDS), and Software Design Specifications (SDS).
- Create, review, and approve commissioning documentation.
- Develop, review, and approve Requirements Traceability Matrix (RTM) documentation.
- Assess and approve Failure Mode and Effects Analysis (FMEA) documentation.
- Develop and review User Manuals.
- Oversee Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documentation.
- Collect qualification test data and provide technical input to resolve discrepancies and deviations.
- Facilitate risk management activities.
- Travel may be required as part of project execution.
Qualifications & Experience
- Bachelor’s degree in Science, Engineering, or a related discipline.
- Minimum of 3 years’ experience in a validation role within a regulated environment.
Key Skills & Abilities
- Proven experience in developing validation documentation for the pharmaceutical and medical device industries.
- Strong organisational skills with a proactive and solutions-focused mindset.
- Ability to multitask and manage multiple projects effectively.
- Excellent communication and stakeholder management skills.
- Strong technical proficiency, including Microsoft Word, Excel, PowerPoint, and MS Project.
- Detail-oriented with strong documentation and analytical skills.
- Ability to work collaboratively across departments.
- Structured and methodical approach to tasks.
- Strong time management and problem-solving abilities.
- Customer-focused approach.
Additional Skills (Preferred)
- Knowledge of 21 CFR Part 11 requirements, Electronic Records/Electronic Signatures (ER/ES), and data integrity guidelines.
- Knowledge in Allen Bradley PLC software, FactoryTalk View software, and coordinate engineers on testing, including database 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.