Responsibilities:

·         Write protocols and reports to support critical facility/Equipment additions or changes (water, air, HVAC, Clean Environments, critical production equipment)

·         Execute portions of the protocol as required

·         Ensure new designs or changes to facilities designs meet regulatory and internal requirements

·         Train employees to protocol requirements

·         Works closely with the Microbiology lab and may perform some Microbiology duties

·         May perform other engineering duties as required

Requirements:

·         Bachelor's degree or above in sciences or engineering is required

·         Minimum 3 years of experience required

·         Facility or Equipment Validation and Verification experience is required (DQ, IQ, OQ, PQ)

·         Software validation experience is a plus

·         Excellent organizational skills, independent thinking, and a high level of initiative are required

·         The ability to work well independently and as a member of a team is essential for success

·         Must have strong communication skills, both verbal and written