Cleaning Validation SME

Join to apply for the Cleaning Validation SME role 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,ergarence of full responsibility for CIP and SIP activities across the project lifecycle.

• 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
  • Bioreactors
• Perform hands‑on execution including: inget a ul>
  • Rinse and swab sampling
  • Visual inspections
  • Riboflavin coverage studies
• Develop and justify load patterns for:
  • Autoclaves
  • Parts washers
  • 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 techniques
  • Visual inspection methods
  • CIP and SIP cycle development
  • Autoclave and washer load pattern development
  • 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

Seniority level: Mid‑Senior level

Employment type: Full-time

Job function: Management and Manufacturing

Industries: Staffing and Recruiting