Cleaning Validation Engineer

Summary

cGMP Consulting, Inc. is seeking an individual to coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations and discrepancies. Oversee and review validation area processes.

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, and address high priority requests. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment. Assuring a steady and accurate completion of the workload on time is key to success in this position.

Responsibilities

• Design and develop cleaning procedures for new product and manufacturing equipment.
• Provide technical support to cleaning activities associated with the manufacturing process.
• Lead the cleaning validation program and activities.
• Knowledge of cleaning agents and establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suite areas.
• Design and support implementation of cleaning strategies for product transfer projects and product development projects.
• Investigate and conduct troubleshooting or root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under developed cleaning procedures.
• Lead enhancement of cleaning practices and review and approve work instructions.
• Support the periodic review of cleaning validation studies.
• Perform successful resolution of incidents and deviations related to cleaning activities.
• Issue change controls required for implementation of cleaning procedure changes.

Requirements

• Minimum 4-year degree.
• 3-5 years of relevant experience in a aseptic manufacturing facility.
• Proficient knowledge of cleaning validation, continuous process improvement, and troubleshooting processes.
• Strong project management skills.
• Proficient in cGMP's, OSHA and FDA regulations as applicable to pharmaceutical manufacturing.