Validation Engineer

Fresenius Kabi USA, LLC; Wilson (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Join a forward-thinking company as a Technical Support Specialist, where you will play a vital role in ensuring equipment compliance and performance. This exciting position involves working with cross-functional teams to enhance plant systems while adhering to regulatory requirements. You will leverage your technical expertise in pharmaceutical processes and cGMPs to conduct validation studies and improve operational efficiencies. With a competitive salary and comprehensive benefits, this role offers a unique opportunity to make a significant impact in a dynamic environment. Embrace the challenge and advance your career in a supportive and innovative workplace.

Benefits

401(k) plan with company contributions

Paid vacation

Health coverage (medical, dental, vision)

Employee assistance program

Wellness programs

Qualifications

• 1-3 years of pharmaceutical manufacturing experience required.
• Knowledge of FDA regulations and cGMPs is essential.

Responsibilities

• Schedule and execute equipment commissioning and qualification.
• Perform validation studies and prepare reports for approval.
• Contribute to validation program improvements.

Skills

Report Writing

Data Recording

Basic Statistical Analysis

Technical Experience with Pharmaceutical Processes

Interpersonal Skills

Project Management Skills

Conflict Resolution Skills

Education

BS/BA in Science or Engineering

Tools

Analytical Instruments

Job description

Job Summary

Responsible for providing technical support to operations in terms of equipment/system initial validation and requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, considering regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (Grade D, C, and up to B/A). Strong report writing, data recording, and basic statistical analysis skills are required. Weekends and off-shift hours are periodically required.

Salary Range: $70,000-$90,000. Final pay determinations depend on experience, education, knowledge, skills, and abilities.

Our benefits include a 401(k) plan with company contributions, paid vacation, holidays, personal days, employee assistance program, and health coverage including medical, prescription, dental, and vision.

Responsibilities

1. Principal Activities
2. Schedule and execute equipment commissioning, qualification, and requalification per SOPs. Coordinate testing, evaluate results, analyze data, and prepare reports for approval.
3. Perform equipment validation studies, including protocol preparation, scheduling, execution, and reporting. Present results to Regulatory Agencies when necessary.
4. Program and operate analytical instruments for controlled environment qualifications.
5. Contribute to validation program improvements to stay current with cGMPs and industry standards.
6. Participate in system installation, validation, troubleshooting, and maintenance teams.
7. Conduct validation deviations and participate in investigations to identify root causes and corrective actions.

Requirements

1. BS/BA in science, engineering, manufacturing technology, or related field, or equivalent experience.
2. 1-3 years pharmaceutical manufacturing experience.
3. Knowledge of FDA regulations, guidance, and GMPs.
4. Technical experience with pharmaceutical processes, sterilization, and cleaning validation.
5. Proactive with team experience, strong interpersonal and project management skills.
6. Ability to interact across company levels.
7. Independent and collaborative work skills, initiative, and results-driven.
8. Strong conflict resolution skills.
9. Willingness to travel domestically and internationally.
10. Flexibility to work multiple shifts to meet deadlines.

Additional Information

We offer competitive salary and benefits, including health coverage, life insurance, disability, 401(k) with company contribution, and wellness programs.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or veteran status.