Job Title: Validation Specialist Engineer
About the Role:
The successful candidate will support several aspects of validation, including sterilisation, cleaning, and controlled temperature units. The role involves designing, authoring, reviewing, approving, and executing qualification/validation documentation and cycle development studies. Additionally, the candidate will engage with production, maintenance, and quality representatives during execution of Cycle Development & Performance Qualification activities.
Responsibilities:
* Design and author qualification/validation documentation and cycle development studies
* Execute qualification/validation activities in accordance with company policies and procedures
* Collaborate with production, maintenance, and quality teams to ensure smooth execution of qualification/validation activities
* Analyse and interpret complex data to link to equipment performance and out-of-specification findings
* Support continuous improvement through Lean Six Sigma methodologies
* Represent the validation team at global technical forums
* Drive compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP)
Requirements:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
* Proven track record in delivering excellence in a GMP manufacturing setting
* Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills
* Exception/Deviation Management and Change Control experience
* Demonstrable experience of leading technical-related projects
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment
Preferred Qualifications:
* Knowledge of Equipment Periodic Validation, Equipment Validation Lifecycle, Project Management Skills/Qualification, Filter Validation & Container Closure Validation, Isolator Qualification, Vial and Syringe Processing Technologies, Temperature Mapping, Cleaning Validation
What We Offer:
We offer a permanent contract of employment with opportunities for career growth and development. As a member of our team, you will have the opportunity to work on challenging projects, develop your skills, and contribute to the success of our organization.
Why Work with Us:
We are a dynamic and growing organization that values innovation, collaboration, and customer satisfaction. Our team is passionate about delivering high-quality solutions that meet the needs of our clients. If you are a motivated and talented individual who is looking for a new challenge, we encourage you to apply.
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