Validation Engineer
Fresenius Kabi USA
Summary
Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalifications. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control.
Job description
Job Summary
Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalifications. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control.
Responsibilities
- Drafts protocols and executes equipment commissioning, qualification, and 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 to include protocol preparation, scheduling, protocol execution, and final report preparation. Participates in presentation of 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.).
- Participates in developments/improvements to validation programs as needed to remain current with cGMPs and industry standards.
- Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Requirements
- Comprehensive understanding of cGMPs
- Ability to write reports clearly, concisely and accurately
- Accurately record data
- Basic understanding of statistical analysis
- Ability to become certified to enter Controlled Areas of the plant (Grade D, C and up to B/A)
- Ability to work weekends and off-shift hours periodically
Benefits
- 401(k) Matching
- Paid Vacation
- Holiday & Personal Days
- Employee Assistance Program
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- Wellness Program
Company overview
Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.