VALIDATION ENGINEER - Fresenius Kabi US : Job Details

Job Summary

POSITION SUMMARY

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification's. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs and become certified to enter Controlled Areas of the plant (Grade D, C and up to B/ A). 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.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

* Schedules and executes equipment commissioning, qualification, and requalification's 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

* BS/BA degree in science, engineering, manufacturing technology or closely related field or equivalent experience in a manufacturing facility

* Minimum 1-3 years pharmaceutical manufacturing experience

* Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices

* Strong technical knowledge and experience with pharmaceutical process, sterilization, and cleaning validation as related to sterile products

* Must be proactive, have experience with high performance teams, strong interpersonal and project management skills

* Must be able to interact with varying levels within the company

* Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results

* Strong conflict resolution skills

* Must be willing to travel both domestically and internationally

* Must be able to work multiple shifts as needed to meet deadlines

Additional Information

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, citizenship, immigration status, disabilities, or protected veteran status.