Title:  Validation Engineer II

Job Summary

Validation Engineer II is expected to execute validation and qualification activities for pharmaceutical manufacturing systems in compliance with cGMP requirements, industry standards, and standard operating procedures under guidance from Manager.

Area Of Responsibility

• Supports the execution of equipment validation and maintenance as required
• Execute, under supervision, equipment qualification and requalification for manufacturing
• Participates in the operation of process equipment  as well as associated documentation
• Support execution of preventative maintenance of pharmaceutical process equipment and utilities
• Supports equipment readiness to support the production schedule and is in proper condition/calibration
• Provide operational coverage for manufacturing equipment and utilities
• Support production personnel on equipment and utility operation
• Support re-qualification of process equipment, testing & certifications of manufacturing process 
• Support area manufacturing and new product/process transfer activities
• Participates in equipment/utility related CAPAs, Deviations, and Investigations
• Review, under supervision, process utilities and equipment logs
• Support loading / lyophylization cycle and coordination of equipment
• Participates in the troubleshoot and remediate exceptions found during FAT/SAT/IQ/OQ/PQ
• Supports timely closure of equipment/utility related CAPAs and/or Change Controls
• Support Validation of equipment/utilities/process transfers and re-qualifications
• Support URS/FS/DS engineering documents of process related systems
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Manufacturing area/clean room area
• Maintenance Shop
• Exposure to noise, hot and cold, outside elements, some radiation

Physical Requirements:

• Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
• Climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell
• Close vision; ability to adjust focus
• Operate computer/office machines, autoclave, depyrogenation oven, vial filler, freeze dryer, steam generators, power tools
• Wear proper gowning and safety equipment as needed
• Lift up to 50 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• Bachelor’s in Science, Engineering or related field preferred or equivalent experience

Experience

• Minimum 4+ years related experience preferred
• Ability to oversee cGMP validation compliance efforts
• Ability to operate and maintain process equipment and utilizes  (Sterilizers, Depyrogenation Ovens, Lyophilers, Incubators, CTU’s)
• Familiarity with FDA cGMP, SOPs and ISO standards
• Knowledge of pharmaceutical manufacturing equipment and utilities
• Familiarity/Knowledge of aseptic techniques
• Excellent organizational skills