Senior Validation Specialist

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

Job summary

An established industry player seeks a Senior Validation Specialist to lead the vision for the Commissioning, Qualification, and Validation (CQV) department. This role involves collaborating with various teams to enhance project outcomes and compliance throughout the validation lifecycle. As a Subject Matter Expert, you will drive improvements and ensure adherence to regulatory standards, contributing to the company's mission of positively impacting lives globally. Join a dynamic environment where your expertise will foster innovation and quality in life sciences, making a meaningful difference every day.

Qualifications

• Strong understanding of regulatory and cGMP guidelines.
• Experience in Mechanical, Chemical, or Biological Engineering.

Responsibilities

• Cultivate relationships across departments to enhance collaboration.
• Drive updates to policies in line with regulations and standards.
• Support CQV team through change management and troubleshooting.

Skills

Regulatory knowledge

cGMP guidelines

Customer insight development

Analytical skills

Education

BSc in Mechanical Engineering

MSc in Chemical Engineering

Equivalent experience in Biological Sciences

Tools

Risk management tools

Quality management systems

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:

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

Key requirements:

1. BSc/MSc or equivalent experience in Mechanical Engineering, Chemical Engineering, Electronic/Electrical Engineering, Automation, Biological Sciences, or Chemistry.
2. Be a technical Subject Matter Expert for at least one area of competency (CSE, Sterilisation, Gas Testing, Clean Room, Equipment Qualification).
3. Proven knowledge of Regulatory and cGMP guidelines, contributing to quality records (Deviations, Investigations, CAPA, and Change Control).
4. Proactively seeks to understand internal/external customer and market needs.
5. Develops insights that can be used to improve customer happiness and other important measurements.
6. 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.