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About the Role
Validates and revalidates new or modified products, equipment, or systems, providing technical support to Operations for initial validation and requalifications.
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.
Requirements
- 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.
- Must be able to effectively speak, read, write, and understand English.
Skills
- Data analysis
- Report writing
- Statistical analysis
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Project
- Microsoft Access
- cGMP knowledge
- Industry guidance knowledge
- Aseptic techniques knowledge
- HEPA Filter integrity testing
- Velocity testing
- Airflow pattern testing
- Smoke generator operation
- Photometer operation
- Velocity meter operation
Experience Level
- 1-3 years pharmaceutical manufacturing experience
Education Level
- BS/BA degree in science, engineering, manufacturing technology or closely related field, or equivalent experience
Salary/Compensations
- $60,966-$85,694 annually
Benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- 401K with company contribution
- Wellness program
About the Company
- Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.
Equal Opportunity
- 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.