Validation Engineer

Fresenius Kabi; Grand Island (NE); On-site; USD 63,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company contributions

Wellness program

Job summary

Fresenius Kabi is seeking a Validation Specialist to validate and revalidate new or modified products, equipment or systems in our manufacturing environment. You will support Operations with equipment/system initial validation and requalifications, ensuring compliance with cGMPs and industry standards.

You will lead protocol development, data analysis, Final Report preparation and coordination with cross-functional teams.

Qualifications

• BS/BA in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 1–3 years pharmaceutical manufacturing experience.
• Excellent attention to detail.

Responsibilities

• Performs equipment requalifications per SOPs, coordinates testing with affected functional groups, evaluates results and circulates Final Report for approval.
• Executes equipment validation studies per SOPs, including protocol prep, scheduling, execution, data analysis and Final Report.
• Programs and operates department analytical instruments for chamber qualifications/requalifications (e.g., lyophilizers, sterilizers, depyrogenation ovens/tunnels).
• Participates in improvements to validation programs to stay current with cGMPs and industry standards.
• Participates in teams to validate and maintain systems and equipment.
• Participates in deviation investigations and corrective/preventive actions.

Skills

Attention to detail

Teamwork

Communication

Education

BS/BA in science or engineering

Tools

MS Office

Job description

Job Summary

Validates and revalidates new or modified products, equipment or systems. Provides technical support to Operations in terms of equipment/system initial validation and equipment/system requalifications.

Salary Range: $63,000 - $$85,000 Annually

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

Our benefits 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

• Performs equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Analyzes data, composes a Final Report and circulates for approval.
• Executes equipment validation studies per SOPs or utilizing reference templates, to include protocol preparation, scheduling, protocol execution, data analysis, Final Report preparation and circulation for approval.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers and thermocouples) to perform controlled temperature/humidity chamber qualifications/requalifications (i.e.: lyophilizers, sterilizers, depyrogenation ovens/tunnels, warehouses, coolers/freezers, incubators, etc.).
• Participates in improvements to validation programs/procedures as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to validate and maintain systems and equipment.
• Participates in deviation investigations and corrective and/or preventative actions (CA/PA).
• Performs HEPA Filter integrity/velocity testing and participates in Critical Area (Class 100) airflow pattern testing. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
• Participates in presentation for Regulatory Agency(s) when necessary.
• Participates in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control.
• All employees are responsible for:

• a) Protecting the environment
• b) Preventing pollution
• c) Complying with applicable requirements as identified in the policy statements
• d) Promoting sustainable practices
• e) Working in accordance with the documented environmental procedures and policies, specific responsibilities defined
• f) Reporting problems or deviations associated with environmental issues and the EMS to the EMR

Responsibilities

• BS/BA degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 1 – 3 years pharmaceutical manufacturing experience.
• Excellent attention to detail.
• Must be proactive, ability to work in high performance teams, strong interpersonal and self-management skills.
• Must be able to interact with varying levels within the company.
• Ability to work both independently and in partnership with others; ability to use initiative and drive to achieve results.
• Ability to write reports, deviations or other technical documents clearly, concisely, and accurately; accurately record data and a basic understanding of statistical analysis.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
• Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.

Additional Information

We offer an excellent salary and benefits package including medical, dental andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.