Validation Specialist
1 week ago
As a Validation Specialist at Fresenius Kabi USA, LLC, you will play a critical role in ensuring the quality and compliance of our equipment and systems. This position requires a strong understanding of cGMPs and the ability to work independently and as part of a high-performance team.
The ideal candidate will have a BS/BA degree in a science, engineering, or manufacturing technology field and a minimum of 1-3 years of experience in pharmaceutical manufacturing. Strong technical knowledge and experience with pharmaceutical process validation, sterilization, and cleaning validation are essential.
Key Responsibilities:
- Schedule and execute equipment commissioning, qualification, and requalification per SOPs.
- Coordinate and communicate testing with affected functional groups and evaluate test results.
- Program and operate department analytical instruments to perform controlled temperature/humidity chamber qualifications.
- Participate in developments/improvements to validation programs to remain current with cGMPs and industry standards.
- Conduct validation deviations and participate in deviation investigations to identify root causes and define corrective and/or preventative actions.
Requirements:
- BS/BA degree in science, engineering, manufacturing technology, or closely related field.
- Minimum 1-3 years pharmaceutical manufacturing experience.
- Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices.
- Strong technical knowledge and experience with pharmaceutical process, sterilization, and cleaning validation as related to sterile products.
- Must be proactive, have experience with high-performance teams, strong interpersonal and project management skills.
- Must be able to interact with varying levels within the company.
- Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
- Strong conflict resolution skills.
- Must be willing to travel both domestically and internationally.
- Must be able to work multiple shifts as needed to meet deadlines.
What We Offer:
We offer an excellent salary and benefits package, including medical, dental, and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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