Katalyst CRO

Sr Validation Engineer

Columbia, MD, US

8 days ago
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Summary

Responsibilities

Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment.

Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.

Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.

Excellent leadership skills include the ability to simultaneously organize, and successfully execute multiple project responsibilities.

Candidates need to possess good communication and interpersonal skills and the ability to interact with all levels of management, clients, and vendors.

Requirements

Strong computer skills are also required.

Minimum 5 years of demonstrated experience with validation of pharmaceutical or medical device processes and equipment.

FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the Pharmaceutical Industry.

Validation experience in the areas of automation, packaging, cleaning, Computer systems, utilities and/or facilities is desired.

Willing and able to travel as necessary for project requirements to include but not limited to project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

Bachelor's degree in electrical engineering, Mechanical Engineering, Chemical Engineering, or equivalent technical degree.

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