Validation Specialist
4 weeks 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. Your primary responsibility will be to provide technical support to operations, including equipment commissioning, qualification, and requalification. You will work closely with cross-functional teams to enhance the compliance and performance of plant systems, while considering regulatory requirements for change control.
Key Responsibilities:
- Schedule and execute equipment commissioning, qualification, and requalification activities in accordance with Standard Operating Procedures (SOPs).
- Coordinate and communicate testing with affected functional groups and evaluate test results.
- Analyze data, compose a final report, and circulate for approval.
- Execute equipment validation studies, including protocol preparation, scheduling, protocol execution, and final report preparation.
- Participate in presentations of results to regulatory agencies when necessary.
- 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.
- Participate in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment.
- Conduct validation deviations and/or 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 a closely related field, or equivalent experience in a manufacturing facility.
- Minimum 1-3 years of 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.
- Proactive, high-performance team experience, strong interpersonal and project management skills.
- Ability to interact with varying levels within the company.
- Ability to work both independently and in partnership with others, with a proven ability to use initiative and drive to achieve results.
- Strong conflict resolution skills.
- Willingness to travel domestically and internationally.
- Ability to work multiple shifts as needed to meet deadlines.
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 a wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer, and 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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