Validation Compliance Engineer

2 weeks ago


Wilson, North Carolina, United States Fresenius Kabi USA, LLC Full time
Job Overview

Position Summary: The Validation Engineer is responsible for delivering technical support to operational teams concerning the initial validation and requalification of equipment and systems.

This role involves active participation in teams focused on enhancing compliance and performance of plant systems, while adhering to regulatory change control requirements.

The candidate must possess a thorough understanding of current Good Manufacturing Practices (cGMPs) and obtain certification to access Controlled Areas of the facility (Grade D, C, and up to B/A).

Key Responsibilities:

  1. Schedule and execute equipment commissioning, qualification, and requalifications in accordance with Standard Operating Procedures (SOPs).
  2. Coordinate and communicate all testing activities with relevant functional groups and assess test outcomes.
  3. Analyze data, prepare comprehensive final reports, and distribute for approval.
  4. Conduct equipment validation studies, including protocol preparation, scheduling, execution, and final report generation.
  5. Engage in presentations of results to Regulatory Agencies when required.
  6. Operate department analytical instruments (e.g., temperature/humidity dataloggers) for controlled temperature/humidity chamber qualifications.
  7. Contribute to the development and enhancement of validation programs to align with cGMPs and industry standards.
  8. Participate in teams tasked with specifying, installing, validating, troubleshooting, and maintaining systems and equipment.
  9. Conduct validation deviations and/or assist in deviation investigations to identify root causes and establish corrective and preventive actions (CA/PA).

Qualifications:

  • Bachelor's degree in science, engineering, manufacturing technology, or a closely related field, or equivalent experience in a manufacturing environment.
  • 1-3 years of experience in pharmaceutical manufacturing.
  • Exceptional attention to detail and a solid understanding of FDA Regulations/Guidance and Good Manufacturing Practices.
  • Strong technical knowledge and experience in pharmaceutical processes, sterilization, and cleaning validation related to sterile products.
  • Proactive mindset with experience in high-performance teams, complemented by strong interpersonal and project management skills.
  • Able to engage with various levels within the organization.
  • Demonstrated ability to work independently and collaboratively; initiative-driven with a focus on achieving results.
  • Strong conflict resolution capabilities.
  • Willingness to travel domestically and internationally as needed.
  • Flexibility to work multiple shifts to meet project deadlines.

Additional Information: Fresenius Kabi is committed to providing an excellent salary and benefits package, including medical, dental, and vision coverage, life insurance, disability, a 401K plan with company match, and a 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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