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Validation Associate

Apex Life Sciences is in need of a Validation Associate for an immediate opening north of the Downtown Cincinnati area.

Purpose of the Validation Associate Position:

• The position is responsible for assisting in the creation, development, maintenance and execution of qualification and validation protocols necessary for achieving and maintaining the validated state of computer systems, equipment, facilities and utilities.

Key Responsibilities:

• Write and execute qualification and validation protocols. • Assist in preparation and review of all validation documentation, including vendor validation documentation (FAT/SAT/IQ/OQ/PQ). • Lead validation deviation investigations. • Ensure the revalidation/requalification of equipment and systems is performed according to the current approved procedure with regard to requirements and timing.

Job Knowledge Required:

• B.S degree engineering discipline or other technical field; or 3-5 years in validation. • Strong organization skills and the ability to communicate to a wide variety of audiences. • Proficiency in Microsoft Office, particularly Microsoft Word, and Adobe Acrobat.

Problem Solving:

 • Work closely with manufacturing and engineering associates to troubleshoot qualification issues. • Use creative thinking to help solve qualification and validation issues. Accountability: • The position is accountable for executing qualification and validation projects to completion, including the final written report. • The position requires that the associate work independently. • The position requires that projects be completed on time, according to set deadlines. • Must be able to work collaboratively with other non-validation positions.

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