Validation Engineer II

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.

Requirements

• 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

Benefits

• Medical
• Dental
• Vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Vacation time
• Sick time