Pharma Validation Engineer – Equipment & Process QA

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

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.