Validation Engineer

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 validation experience, documentation experience and experience working within 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:

• Conduct PQs for parts washers and other cleaning equipment
• Define cleaning parameters & take samples
• Assist with CIP procedures and systems
• Communicate with vendors and teams onsite
• Develop and execute cleaning validation protocols and reports for new equipment and facilities.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigate and resolve deviations and discrepancies related to cleaning validation.
• Maintain accurate and detailed documentation of all cleaning validation activities.

Must Haves:

• 3+ years of experience with cleaning validation
• Bachelors Degree in Engineering or related field
• Experience with cGMP documentation and validation life cycle
• 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