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Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. Baxter Healthcare Ltd North West Compounding is currently seeking an experienced Validation Engineer to join our team on site. Our company is dedicated to upholding a seamless validation process for our manufacturing facility, equipment, processes, and systems. As a Validation Engineer, you will have a vital role in ensuring our site adheres to Good Manufacturing Practices (GMP) and regulatory standards.
Job Responsibility
Ensure Site Validation Master Plan (SVMP) is strictly adhered to and that all validation activities are conducted in accordance with established protocols and procedures by executing validation work and a variety of equipment
Develop and implement validation documents and protocols for a variety of processes, equipment, facilities, and systems, with a particular emphasis on aseptic manufacturing
Work closely with the validation team and teams from various departments to assist with the implementation of new processes, products, and equipment at the site
Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems
Conduct thorough reviews of validation execution and equipment changes carried out by external contractors and internal project team members to ensure compliance with validation requirements
Take ownership of project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio
Work with Quality Assurance to react to adhoc validation requirements
Requirements
Scientific/Engineering Degree or equivalent qualification or the right experience within a validation role
Experience working with Hydrogen peroxide decontamination systems
In depth knowledge of a specific validation/engineering skill set i.e. temperature mapping, airflow and smoke visualization, Biological Indicator application and processing etc
Working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferably
Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be preferred
Approach tasks with a logical and practical perspective, and have a proactive approach to problem-solving
Display analytical thinking and innovative problem-solving abilities to successfully implement validation strategies
Self-motivated and driven to complete projects/tasks efficiently and effectively
Excellent teamwork skills to contribute effectively as a member of a diverse team and effectively communicate with individuals involved in the project
Nice to have
Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems
Support validation activities across all UK Compounding sites