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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. You will collaborate closely with a diverse team, allowing you to gain exposure to various areas of our organisation. This unique aspect of the role offers exceptional prospects for career progression within our world-class company.
Duties & Responsibilities
- 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. (Sometimes to support the operational status of the facilities there may be a small amount of weekend work)
- 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.
- Develop detailed documentation, including Validation Plans (VP), User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Actively participate in the assessment, review, and approval of changes that may impact the validation status of our facilities, equipment, processes, and systems, ensuring the correct operation of our change control process.
- 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.
- Support validation activities across all UK Compounding sites.
Qualifications
- 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 (e.g., temperature mapping, airflow and smoke visualization, Biological Indicator application and processing).
- Demonstrated working knowledge of validation in a pharmaceutical/FMCG/medical devices environment preferred.
- Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems preferred.
- Approach tasks with a logical and practical perspective, and 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 and effective communication with individuals involved in the project.
Benefits
- Competitive total compensation package
- Professional development opportunities
- High importance placed on work life balance
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Equal Employment Opportunity Statement
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Baxter is committed to providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.
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