Validation Engineer (Cleaning) Job at Insight Global in Holly Springs

Overview

A large pharmaceutical client is seeking a team of Cleaning Equipment Validation Engineers to support their site build out in Raleigh–Durham. The ideal candidate will have hands-on cleaning validation experience, documentation experience, and experience working within a regulated pharmaceutical environment. The first 3–4 months will be heavily focused on documentation and protocols. Once engineering runs begin in the fall, the role will move into the field supporting cleaning validation activities on the floor. Samples will be taken, protocols filled, and swaps taking place. Mid next year the site will move into 24/7 operations.

Responsibilities

• During the initial phase, focus on documentation and protocol preparation for cleaning validation.
• Transition to field execution of cleaning validation activities on the floor as engineering runs commence.
• Collect samples, complete validation protocols, and perform necessary swaps.
• Support the site as it progresses toward 24/7 operations late next year.

Must Haves / Qualifications

• 3+ years of experience with cleaning validation
• Bachelor’s Degree in Engineering or related field
• Experience with cGMP documentation and validation lifecycle
• Experience writing cleaning validation reports, risk assessments, protocols, and investigating and resolving deviations
• Experience with Kneat – high preference for this
• Experience with greenfield, brownfield or new facility build outs desirable

Compensation

Base pay range: $60.00/hr - $75.00/hr

Location: Raleigh-Durham, NC