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 play a vital role in ensuring our site adheres to Good Manufacturing Practices (GMP) and regulatory standards.
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 on a variety of equipment. (Occasional weekend work may be required.)
* 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, developing detailed documentation including Validation Plans, User Requirement Specifications, Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
* 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.
* Collaborate with Quality Assurance to respond to ad hoc validation requirements.
* Support validation activities across all UK Compounding sites.
What experience are we looking for?
* Scientific/Engineering Degree or equivalent qualification, or relevant 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 is preferred.
* Experience with equipment/process systems, cleaning validation, HVAC, QA, QC, or cleanroom systems is preferred.
* Logical, practical approach to tasks and proactive problem‑solving skills.
* Analytical thinking and innovative problem‑solving abilities to implement validation strategies.
* Self‑motivated and driven to complete projects/tasks efficiently and effectively.
* Excellent teamwork skills and effective communication within a diverse team.
What are some of the benefits of working at Baxter?
* Competitive total compensation package.
* Professional development opportunities.
* High importance placed on work‑life balance.
Equal Employment Opportunity
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.
Reasonable Accommodations
Baxter is committed to working with and 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 click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
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