Cleaning Validation Specialist
1 week ago
About the Role
cGMP Consulting, Inc. is seeking a highly skilled Cleaning Validation Engineer to coordinate cleaning validation activities. The ideal candidate will prepare and execute protocols and reports for cleaning development and validation, perform investigation of deviations and discrepancies, and oversee and review validation area processes.
Key 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.
- Establish 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.
About cGMP Consulting
cGMP Consulting, Inc. is a leading provider of cleaning validation services to the pharmaceutical industry. We are committed to delivering high-quality services that meet the needs of our clients.
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