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Medical Validation Specialist
1 month ago
At Baxter, we are deeply connected by our mission to save and sustain lives. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Key Responsibilities:
- Develop and implement validation documents and protocols for various processes, equipment, facilities, and systems, with a focus on aseptic manufacturing.
- Collaborate with cross-functional teams to implement new processes, products, and equipment at the site, including creating detailed documentation such as Validation Plans, User Requirement Specifications, Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.
- 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.
- Lead project management and execution for Capital Expenditure and Process Improvement Projects within the EMEA Validation project portfolio.
Requirements:
- You will have a Scientific/Engineering Degree or equivalent qualification.
- You will be able to demonstrate working knowledge of validation in a pharmaceutical/FMCG/medical devices environment.
- Experience with Equipment/Process systems, Cleaning Validation, HVAC, QA, QC, or Cleanroom systems would be beneficial.
- 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.
What We Offer:
- Competitive total compensation package
- Professional development opportunities
- High importance placed on work-life balance
- Commitment to growing and developing an inclusive and diverse workforce.
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.
