Sr. Validation Engineer

Fresenius Kabi USA•Melrose Park, IL

1d•$80,000 - $100,000•Onsite

About The Position

This is an onsite, full-time salaried role. This position is not eligible for visa sponsorship now or in the future. The role is responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. The individual 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 display a solid technical understanding of validation principles and be able to lead validation projects showing proficiency in project and time management skills. 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. The role also involves maintaining and constantly improving the ISO 50001 energy management system, identifying energy savings opportunities, making recommendations for more energy-efficient operations, and monitoring and analyzing energy consumption. All employees are responsible for ensuring compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Requirements

Bachelor degree in Engineering or a Scientific Field required
Minimum of 3 years relevant experience in a cGMP facility; pharmaceutical industry experience preferred
Proficient in generating reports, technical writing/reviewing skills and other technical documents required
Knowledge and understanding of cGMPs, industry guidance and aseptic techniques needed
PC literate with Microsoft Office proficiency
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.

Nice To Haves

Pharmaceutical industry experience preferred

Responsibilities

Independently plan, perform and document validation activities (IQ, OQ, PQ) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing environment.
Create validation schedules, coordinate execution efforts with contractors, production operators, manufacturing engineers and quality assurance personnel.
Track and communicate progress of work against milestones.
Compose validation plans, protocols, traceability matrices, risk assessments and final report summaries.
Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
Represents Validation in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
Conduct and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Responsible for maintaining and constant improvement of the ISO 50001 energy management system.
Identify energy savings opportunities and make recommendations to achieve more energy efficient operation.
Monitor and analyze energy consumption.
Ensure compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems.