Quality Validation Specialist

Job Responsibilities:

• Review documentation for compliance and Quality approval, including but not limited to: equipment and software (process equipment, computerized systems, facilities, utilities, laboratory equipment as needed) commissioning
• Reviewing/Approving IQ/OQ/PQ protocols and reports
• Reviewing/Approving Equipment and software validation lifecycle documents (e.g. URS, TM, etc.)
• Reviewing/Approving Cleaning validation protocols and reports
• Reviewing/Approving process validation protocols and reports.
• Provide Quality oversight to the periodic qualification evaluation (PQE) program to ensure timeliness of execution and documentation completion.
• Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
• Ability to manage multiple projects in a fast-paced environment.
• Provide support during normal hours (8 AM – 5 PM Monday-Friday) and after business hours as needed.

Qualifications:

• Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
• Minimum of 2 years of biopharma industry experience with increasing responsibilities in Commissioning, Qualification, and Validation.
• General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).  
• Experience with executing or providing oversight for CQV activities for FDA/EMA regulated facilities.
• Experience with CQV activities for aseptic manufacturing facilities or clean utilities (e.g. Water for Injection, Clean Steam, etc.).
• Experience utilizing electronic validation execution systems (e.g. KNEAT, ValGenesis). 

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