Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.
Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs).
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Assembles and composes the final report and circulates for approval.
Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation.
Presents results to Regulatory Agency when necessary.
Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
Schedules and executes HEPA Filter and Critical Area (Class 100) testing per SOP.
Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Minimum 4-year degree in a Science or Engineering field of study; or equivalent experience.
Analytical datalogger programming, operating, troubleshooting, data-collecting.
Generation of reports, deviations or other technical documents.
Installation, Operational and Performance Qualification protocol generation and execution.
PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
Understanding of statistical analysis tools and methods.
1-3 years of related experience in a cGMP facility.
Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
Knowledge of cGMP Cleaning Validation requirements and techniques.
Knowledge of cGMP Process and Product Validation requirements and techniques.
Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.