Sr. Validation Engineer

Fresenius Kabi; Wilson (NC); Vor Ort; USD 74.000 - 104.000; Vollzeit

Benefits dieser Stelle

401(k) plan

Paid vacation & holidays

Health benefits

Zusammenfassung

Fresenius Kabi in Wilson, NC seeks a Validation Specialist to provide technical support for equipment/system initial validation and requalification. You will coordinate HEPA testing, critical area airflow studies, and stay current with cGMP requirements while supervising validation staff and contractors.

The role includes project management of validation studies, protocol development, testing coordination, and presenting results to regulatory bodies as needed.

Qualifikationen

• Comprehensive understanding of cGMPs.
• Certified to enter controlled areas of the plant.
• Experience coordinating validation activities and teams.
• Project management or technical reviewer experience preferred.

Aufgaben

• Schedule and participate in equipment requalifications and testing with affected groups.
• Execute validation studies and prepare protocols, schedules, and final reports.
• Present results to Regulatory Agencies when necessary.
• Operate and program monitoring instruments for chamber qualifications and analyses.
• Develop and improve validation programs to stay current with cGMPs.
• Lead testing of HEPA filters and critical areas and document results.
• Collaborate with teams to install, validate, troubleshoot and maintain systems.

Jobbeschreibung

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

• 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, and wellness 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.