Pharma Validation Engineer — GMP & Compliance

301044 Fresenius Kabi USA, LLC; Town of Grand Island (NY); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental and Vision

401K with company contribution

Job summary

Fresenius Kabi USA, LLC seeks a validation professional to verify and revalidate pharmaceutical systems and equipment. You will support operations with initial validation, equipment requalifications, and data-driven Final Reports.

Responsibilities include SOP-based studies, instrument programming, and cross-functional collaboration to ensure regulatory compliance and quality. Strong analytical and communication skills are essential, with 1–3 years in pharma manufacturing.

Qualifications

• BS/BA in science, engineering, manufacturing tech, or equivalent experience.
• 1–3 years pharmaceutical manufacturing experience.
• Excellent attention to detail and proactive work style.
• Able to work independently and in teams; strong communication and self-management.
• Knowledge of cGMPs, aseptic techniques and regulatory expectations.

Responsibilities

• Perform equipment requalifications per SOPs and document results.
• Coordinate testing with affected groups and evaluate results.
• Analyze data; draft Final Reports and obtain approvals.
• Execute validation studies per SOPs; prepare protocols and reports.
• Operate instruments (dataloggers, thermocouples) for chamber qualifications.
• Suggest improvements to validation programs to stay compliant.
• Participate in teams to validate and maintain systems/equipment.
• Contribute to deviation investigations and CAPA actions.
• Conduct HEPA tests and airflow pattern checks where applicable.
• Operate test equipment (smoke generators, photometers, velocity meters).
• Present findings to Regulatory Agencies when required.
• Join equipment-improvement groups to enhance performance and compliance.

Skills

Attention to detail

Teamwork

Self-management

Report writing

Analytical thinking

Interpersonal skills

Cross-level communication

Education

BS/BA in science/engineering/manufacturing

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Microsoft Access

Job description

Fresenius Kabi USA, LLC seeks a validation professional to verify and revalidate pharmaceutical systems and equipment. You will support operations with initial validation, equipment requalifications, and data-driven Final Reports.

Responsibilities include SOP-based studies, instrument programming, and cross-functional collaboration to ensure regulatory compliance and quality. Strong analytical and communication skills are essential, with 1–3 years in pharma manufacturing.