Our Inchinnan site is experiencing further growth across our Operations and Support functions and as we continue to grow and expand the site capabilities, we require an experienced Validation Engineer. In this role you will assist with the definition and implementation of operation validation activities that ensure effective oversight of the verification and validation activities, in compliance with EU/FDA regulatory requirements across all manufacturing and project activities.
What will you do?
Support process validations onsite and act as a subject matter expert in customer and regulatory audits
Support Software, Shipping, Room and Equipment qualifications in line with training and experience
Work with extended validation team to maintain and develop validation master plan and documentation onsite
Provide technical expertise and knowledge on validation to manufacturing group and beyond.
Drive continuous improvement throughout the site with respect to validation activities
Support during internal / external third party audits
Work closely with Production, Technical , Facilities and Manufacturing Engineering to resolve quality related issues arising from customer complaints/concerns and internal incidents
Who we are looking for:
Knowledge of current guidelines and regulatory requirements
Ability to Mentor , Coach and develop other team members within Engineering and across functions to deliver change and process improvements and meet regulatory requirements
Excellent oral and written communication skills
A self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organisation.
Ability to learn and develop current skills and behaviours to progress within the function and lead by example
Excellent knowledge of Validation processes (IQ/OQ/PQ) and current regulatory requirements related to ISO13485/FDA CFR.
Experience working within a medical device manufacturing environment or cGMP manufacturing environment.
Working knowledge of validation within a GMP manufacturing environment
What’s in it for you:
Contributory Pension Scheme
Private medical insurance
Free on site car parking
On site gym – subsidised
Generous Annual Incentive Plan
A variety of flexible benefits
25 days annual leave + public holidays
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientic, it’s not just a career. It’s a chance to realise your best – professionally and personally.