Senior Validation Engineer

The Senior Validation Engineer leads and delivers validation packages for bespoke automated equipment in a high-tech automation company serving FDA-regulated manufacturers. This is a hybrid role with 80% – 100% remote working available.

Key Responsibilities:
• Develop, communicate, and execute validation strategies per GAMP, GMP/GEP, and customer requirements.
• Support Project Engineering Leads and Project Managers in achieving key milestones and managing documented evidence.
• Act as the lead contact for machine validation/test activities.
• Monitor and communicate project variables (Time, Cost, Scope, Risk, Changes) to the Team Leader and Project Manager.
• Ensure best validation practices are employed across the company.
• Generate and review validation documentation (URS, PQMP, FMEA, VPP, Design Specifications, FAT, SAT, RTM, User manuals, validation reports).
• Mentor junior engineers and co-ops.
• Liaise with customers to obtain necessary project information.
• Potential travel required.

Qualifications & Experience:
• Bachelor’s degree in science or engineering.
• Minimum 5 years of validation experience within a regulated environment.
• Experience in devising and executing validation strategies, master planning, and validation close-out activities.
• Knowledge of the Life Science regulatory landscape and industry trends.
• Extensive experience with validation documentation and execution of FAT & SAT protocols.

Quality and Innovation
• Lead project teams, share knowledge, and support problem-solving.
• Provide feedback on team members to the Team Leader.
• Contribute to training plans and mentor junior team members.
• Drive continuous improvement tasks and departmental goals.

• Present validation strategies clearly and effectively.
• Maintain regular communication within project teams and departments.
• Lead project and customer meetings from a validation perspective.
• Communicate schedule risks, issues, and solutions to Team Lead and Project Manager.
• Collaborate across departments for shared project ownership.

Key Skills & Abilities:
• Strong documentation bias
• Attention to detail
• Analytical thinking
• Team collaboration
• Strong written communication skills
• Structured work approach
• Time management
• Initiative
• Customer focused

What we offer:
At Modular Automation, 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 Modular Automation:
Modular Automation, based in Shannon, Co. Clare, is an engineering company offering automation and integration solutions to the world’s leading medical technology manufacturers. We excel in the integration of the latest engineering technologies such as collaborative and autonomous mobile robots (AMR’s), machine tending and transport solutions, and Industry 4.0 applications. Our company’s excellence is rooted in a fusion of pioneering design, advanced engineering, and an unwavering dedication to precision.

In November 2023, Automated Industrial Robotics Inc from Los Angeles, USA and funded by ARES Management private equity group, acquired Modular Automation, and began forming a new company – AIR – to bring together a specialist Automation organisation consisting of constituent SME automation companies with complimentary skills, capabilities, and track records. Modular sits within this new company global company, whilst retaining its brand, strategy, and leadership team.

Our purpose at Modular is to enable the world’s leading medical technology companies to manufacture sophisticated, ultra-high quality, life-changing products, at scale. Over our 40-year history, we have garnered a significant reputation with our customers for delivering innovative and reliable automation solutions. We are proud at Modular, to work within a talented and diverse community of professionals who bring expertise and innovation into solving the automation challenges of our medical device customers.

For ten consecutive years, Modular has received recognition by Deloitte as a Platinum level “Best Managed Company”. We operate in a customer-centric and collaborative culture and environment, and the way our team works together and with our partners and customers builds long-term trust and deep relationships. We have the expertise, commitment, and determination to make the unknown known, and our team will go the extra mile to make it happen.

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. Modular Automation is an equal opportunities employer.
Modular Automation is an Equal Opportunities Employer

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