Validation Engineer

Responsibilities:

The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.

Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports.

Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.

Ability to work independently.

Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns. Requirements:

BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.

4+ years relevant experience commissioning/validating in an FDA regulated industry.

Autoclave / Parts Washer Qualification experience is required.

Experience in 1 or more of the following is desired: facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.

Excellent technical problem-solving and troubleshooting skills.

High attention to detail.

Expertise in Microsoft Word and Excel

Excellent oral and written English are required.

Able to travel domestically and internationally if required.