Validation Engineer

Fresenius Kabi•Grand Island, NY

About The Position

The Validation Engineer validates and revalidates new or modified products, equipment, and systems, and provides technical support to Operations for initial equipment and system validation and requalification. The role performs qualification testing, evaluates and documents results, and helps maintain validation programs and procedures in line with cGMPs, industry standards, and regulatory requirements. The position also supports HEPA filter integrity and velocity testing, critical-area airflow pattern testing, deviation investigations, corrective and preventive actions, equipment improvement teams, and regulatory agency presentations when necessary. Employees are expected to support environmental protection, pollution prevention, sustainable practices, and compliance with documented environmental procedures and policies.

Requirements

BS/BA degree in science, engineering, manufacturing technology, or a closely related field, or equivalent experience in a manufacturing facility.
1–3 years of pharmaceutical manufacturing experience.
Excellent attention to detail.
Proactive, with the ability to work in high-performance teams and strong interpersonal and self-management skills.
Ability to interact with varying levels within the company.
Ability to work independently and in partnership with others, using initiative and drive to achieve results.
Ability to write clear, concise, and accurate reports, deviations, and other technical documents; accurately record data; and demonstrate a basic understanding of statistical analysis.
PC literacy and competency with standard office applications, including Word, Excel, PowerPoint, Project, and Access.
Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.

Responsibilities

Perform equipment requalifications according to Standard Operating Procedures (SOPs).
Coordinate and communicate testing with affected functional groups and evaluate test results.
Analyze data, prepare final reports, and circulate reports for approval.
Execute equipment validation studies according to SOPs or reference templates, including protocol preparation, scheduling, execution, data analysis, and final-report preparation and approval.
Program and operate analytical instruments, including temperature and humidity dataloggers and thermocouples, for controlled-temperature and humidity chamber qualifications and requalifications.
Participate in improvements to validation programs and procedures to keep them current with cGMPs and industry standards.
Participate in teams that validate and maintain systems and equipment.
Participate in deviation investigations and corrective and/or preventative actions (CA/PA).
Perform HEPA filter integrity and velocity testing and participate in Critical Area (Class 100) airflow pattern testing.
Program and operate test equipment such as smoke generators, photometers, and velocity meters, and accurately record and evaluate results.
Participate in presentations for regulatory agencies when necessary.
Participate in equipment improvement teams focused on plant-system compliance and performance, considering regulatory change-control requirements.
Protect the environment, prevent pollution, comply with applicable requirements, promote sustainable practices, follow documented environmental procedures and policies, and report environmental or EMS problems or deviations to the EMR.