Validation Engineer

Fresenius Kabi•Grand Island, NY

11d

About The Position

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.

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 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.

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.