Sr. Cleaning Validation Engineer

Sr. Cleaning Validation Engineer at Stark Pharma

Location: Raleigh, NC (Onsite)

Experience: 7-10 years

This role supports a New Product Introduction program focused on biologics manufacturing. The work centers on facility modifications tied to tech transfer and long-term throughput improvements. You'll own the Cleaning Validation scope, with full responsibility for CIP and SIP activities across the project lifecycle. You're the go‑to expert ensuring cleaning processes are designed, executed, and validated the right way from day one.

• Lead all CIP and SIP validation activities for the NPI program
• Develop, review, and execute cleaning validation protocols and reports
• Design and optimize CIP and SIP cycles for process piping, transfer panels, and bioreactors
• Perform hands‑on execution including rinse and swab sampling, visual inspections, and riboflavin coverage studies
• Develop and justify load patterns for autoclaves, parts washers, and glass washers
• Support tech transfer activities and integration into manufacturing operations
• Collaborate closely with Engineering, Automation, Manufacturing, and Quality teams
• Ensure all activities meet GMP and regulatory expectations

• 7-10 years of validation experience within pharmaceutical or biologics manufacturing
• Minimum 5 years of direct Cleaning Validation experience
• Proven hands‑on experience with rinse and swab sampling, visual inspection methods, CIP and SIP cycle development, autoclave and washer load pattern development, and riboflavin study execution
• Strong experience working with Delta
  
  V automation for CIP and SIP systems

• Experience using Ellab Val Suite Pro
• Experience with Val Genesis for electronic protocol authoring, execution, and review

Mid‑Senior level

Full‑time

Quality Assurance

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