Pharma Validation Engineer - Elevate Compliance & Quality

Fresenius Kabi USA, LLC; Grandyle Village (NY); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a specialist to validate and revalidate pharmaceutical equipment and systems, providing technical support to Operations for initial validation and requalifications. The role includes planning, executing, data analysis, and Final Reports to support compliance.

Salary ranges from $60,966 to $85,694 annually, with final pay determined by experience, education, knowledge, and abilities.

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.
• Proactive, able to work in high performance teams, strong interpersonal and self-management skills.
• Able to interact with varying levels within the company.
• Able to work independently and with others; show initiative and drive.
• Ability to write reports, deviations or other technical documents clearly and concisely; record data accurately; basic statistical analysis understanding.
• PC literate with Word, Excel, PowerPoint, Project, Access.
• Knowledge of cGMPs, industry guidance, and aseptic techniques.
• English fluency for policies, training materials, and workplace communications.

Responsibilities

• Performs equipment requalifications per SOPs; coordinates and communicates testing with affected groups; evaluates results and circulates for approval.
• Executes equipment validation studies per SOPs; prepares, schedules, executes protocols; analyzes data and prepares Final Reports.
• Programs and operates analytical instruments (e.g., dataloggers, thermocouples) for temperature/humidity chamber qualifications and requalifications.
• Participates in improvements to validation programs/procedures to stay current with cGMPs and industry standards.
• Participates in teams to validate and maintain systems and equipment.
• Participates in deviation investigations and CAPA actions.
• Performs HEPA filter integrity/velocity testing and participates in Class 100 airflow pattern testing; operates test equipment and records results.
• Contributes to presentations for regulatory agencies when needed.
• Participates in equipment improvement teams focusing on compliance and change control.

Skills

Attention to detail

Proactive work style

Team collaboration

Interpersonal skills

Self-management

Independent work

Education

BS/BA in science/engineering/manufacturing technology

Tools

MS Office

Job description

Fresenius Kabi USA, LLC is seeking a specialist to validate and revalidate pharmaceutical equipment and systems, providing technical support to Operations for initial validation and requalifications. The role includes planning, executing, data analysis, and Final Reports to support compliance.

Salary ranges from $60,966 to $85,694 annually, with final pay determined by experience, education, knowledge, and abilities.