Validation Engineer

Role : Validation

Location: WI

Duration: 6 months

Key Responsibilities

• Lead and execute comprehensive smoke studies, including airflow visualization and identification of stagnant air or pass-through airflow issues.
• Support and evaluate pressurization challenge studies, assessing system behavior during loss of differential pressure.
• Perform temperature mapping for rooms, processes, and small equipment.
• Review vendor commissioning data, including:
• Temperature
• Humidity
• Air exchanges
• HVAC inputs and performance metrics
• Review URS and vendor IQ/OQ documentation; perform verification testing as required.
• Support electrical verification, P&ID walkdowns, and redline updates.
• Lead qualification of small equipment such as:
• Biosafety cabinets
• Sorbents
• Centrifuges
• QC and process instruments
• Determine whether smoke studies and other tests should be performed internally or through external vendors.
• Document qualification results, compile required data packages, and maintain compliance with quality standards.
• Provide weekly project updates, track basic scope/schedule/cost metrics, and maintain clear communication with clients and vendors.
• Support Environmental Monitoring Performance Qualification (EMPQ) activities.

Required Experience & Qualifications

• 8 years of hands-on validation experience in pharmaceutical, biotech, or related regulated industries.
• Demonstrated ability to independently lead validation activities with minimal oversight.
• Strong expertise in:
• Facility qualification
• Smoke studies
• Temperature mapping
• Small equipment verification
• Ability to think critically and proactively recommend additional or supplemental testing.
• Highly organized with strong communication skills.
• Must be able to manage workload without heavy supervision or guidance.