Sr. Validation Engineer

Fresenius Kabi USA; Wilson (NC); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Medical, dental and vision coverage

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA in Wilson, NC is seeking a Validation Specialist responsible for providing technical support for initial validation and requalification of equipment/systems. The role includes coordinating HEPA/critical area testing, ensuring cGMP compliance, and leading validation projects with a team of professionals.

Salary range is $73,614 to $103,528 with a target bonus of 6%. Benefits include medical, dental, vision, 401(k) contributions, and paid time off; all employment is at-will.

Qualifications

• Comprehensive understanding of cGMPs and regulatory considerations.
• Experience with validation studies and requalification.
• Ability to lead validation projects and teams.

Responsibilities

• Schedule and participate in equipment requalifications per SOPs and communicate results.
• Execute validation studies and prepare/provide final reports.
• Present results to Regulatory Agency when necessary.
• Operate equipment like temperature/humidity dataloggers for chamber qualifications.
• Develop and improve validation programs to stay current with cGMPs.
• Coordinate HEPA filter testing and airflow pattern testing per SOP.
• Represent Validation department in cross-functional teams.
• Investigate deviations and identify corrective and preventive actions.

Skills

cGMP knowledge

Validation techniques

Project management

Regulatory interactions

Tools

Temperature/humidity dataloggers

Photometers

Velocity meters

Job description

Job Summary

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also coordinate HEPA filter integrity/velocity testing and critical area airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant.
Provides direction through direct or indirect supervision to validation team members and contractors as necessary.

Salary Range: $73,614 - $103,528

Position is eligible to participate in a bonus plan with a target of 6% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Schedules and participates in equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups, where applicable, and evaluates test results. Approves final report and/ or assembles and circulates for approval when necessary.
• Executes validation studies, or acts as a Project Manager and/ or Technical Reviewer, for equipment to include protocol preparation, scheduling, protocol execution, and final report preparation.
• Presents results to Regulatory Agency when necessary.
• Programs, leads and/ or operates department instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Schedules and executes, when applicable, HEPA Filter and critical area testing per SOP, and airflow pattern testing. Programs, leads, and/or operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
• Represents Validation department in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.