Senior Validation Specialist

Lonza; Slough; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Validation Specialist to lead and innovate within the Commissioning, Qualification, and Validation (CQV) department. This role involves defining the vision and strategy while collaborating with various teams to ensure compliance and quality throughout the validation lifecycle. You will be a Subject Matter Expert in critical areas, driving improvements and fostering positive relationships across departments. Join a company dedicated to making a meaningful impact on lives globally, where your expertise will contribute to the advancement of life sciences and enhance customer satisfaction.

Qualifications

• BSc/MSc or equivalent experience in relevant engineering or biological sciences.
• Proven knowledge of regulatory guidelines and quality records.

Responsibilities

• Cultivate relationships between departments to ensure alignment.
• Drive updates to policies and procedures in line with regulations.
• Troubleshoot technical issues to maintain smooth operations.

Skills

Regulatory and cGMP guidelines knowledge

Technical Subject Matter Expert

Customer performance analysis

Problem-solving

Education

BSc in Mechanical Engineering

MSc in Chemical Engineering

Equivalent experience in Biological Sciences

Job description

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The role:

The Senior Validation Specialist at Lonza is responsible for working with the Head of Validation in defining the vision and strategy for the Commissioning, Qualification, and Validation (CQV) department. You will be working with colleagues and internal customers sharing knowledge and experience, in all technical areas and aspects of project work throughout the validation lifecycle and determining innovation and identifying compliance requirements in the validation lifecycle.

Be a technical Subject Matter Expert for at least one area of competency (CSE, Sterilisation, Gas Testing, Clean Room, Equipment Qualification)!

Key responsibilities:

• Cultivate positive relationships between QA, Manufacturing, Quality Control, Development Services, Project Management, business services, and maintenance departments.
• Support and successfully implement a risk-based approach to CQV.
• Drive updates to policies & procedures in line with current regulations and industry standards, continuously challenging and improving working practices and performance.
• Provide support and input for site projects and initiatives, ensuring that the CQV team is aligned.
• Manage changes aligned with business objectives and support the CQV Team through change to ensure positive outcomes.
• Troubleshoot technical issues to guarantee smooth operations.
• Contribute towards supporting Deviation, CAPA, Out Of Specification (OOS), and Out Of Trend (OOT) investigations.

Key requirements:

• BSc/MSc or equivalent experience in Mechanical Engineering, Chemical Engineering, Electronic/Electrical Engineering, Automation, Biological Sciences, or Chemistry.
• Be a technical Subject Matter Expert for at least one area of competency (CSE, Sterilisation, Gas Testing, Clean Room, Equipment Qualification).
• Proven knowledge of Regulatory and cGMP guidelines, contributing to quality records (Deviations, Investigations, CAPA, and Change Control).
• Proactively seeks to understand internal/external customer and market needs.
• Develops insights that can be used to improve customer happiness and other important measurements.
• Employs meticulous methods to track and analyse customer performance indicators for continuous improvement.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.