Validation Engineer

RXinsider LTD.; Grand Island (NE); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401K with company contribution

Wellness program

Job summary

Fresenius Kabi seeks a qualified professional to validate and revalidate equipment, systems, and processes in a high-regulation manufacturing environment. You will support Operations with initial validation and requalifications, generate final reports, and participate in deviation investigations.

The role requires a BS/BA in a science or engineering field, 1–3 years of pharma manufacturing experience, and strong data analysis, reporting, and teamwork skills.

Qualifications

• 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.

Responsibilities

• Performs equipment requalifications per SOPs and coordinates testing with affected functional groups.
• Executes equipment validation studies including protocol prep, scheduling, execution, data analysis, and Final Report.
• Programs and operates department analytical instruments to perform chamber qualifications/requalifications.
• Participates in improvements to validation programs to stay current with cGMPs.
• Participates in teams to validate and maintain systems and equipment.
• Participates in deviation investigations and corrective and/or preventative actions.
• Performs HEPA filter testing and airflow pattern testing; records and evaluates results.
• Participates in presentations for Regulatory Agency when necessary.
• Participates in equipment improvement teams considering change control requirements.

Skills

Attention to detail

Proactive

Team collaboration

Interpersonal skills

Self-management

Report writing

Data recording & statistics

Computer literacy

cGMP knowledge

English proficiency

Education

BS/BA in science or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Microsoft Project

Microsoft Access

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: $60,966-$85,694 annually

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

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.


• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

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.