Validation Engineer

New opening for a Validation Engineer to and join a globally recognized Biopharmaceutical organization at their 600,000 square feet manufacturing site in Ohio on a 12-month contract.

This is a unique opportunity to work on a potential blockbuster drug alongside some of the elite professionals in the industry, with end-to-end drug product manufacturing capabilities, including aseptic filling, inspection and packaging.

Job Description:

• Perform assigned equipment, cleaning, and processing validation studies. Coordinate and communicates with stakeholders to ensure accurate and timely completion of the studies.
• Perform testing and documents test results throughout the stages of production / unit operations as required by the approved protocols.
• Analyze study results for load development, IOPQ, processing validation, cleaning validation/verification. Statistical tools and scientific method will be utilized in the analysis of the study data to draw conclusions.
• Write studies, protocols, and reports.
• Conduct peer-review of studies, protocols, and reports

Requirements:

• Minimum 3 years related industry experience required.
• At least 3 years of experience in pharmaceutical/biotech operations, with thorough working knowledge of production unit operations and validation principles.

If you or anyone in your network could be of interest, then please email Dan Zena at d.zena@x4lifesciences.com for more information.