Process & Cleaning Validation Specialist Ii

PPD (Thermo Fisher)

UK
Sterile manufacturing process validation
Cleaning validation and contamination control
Aseptic process simulations (aps/media fill)
The role independently manages the full lifecycle of validation and continued process verification for sterile manufacturing processes

Job Summary

  • The role independently manages the full lifecycle of validation and continued process verification for sterile manufacturing processes.
  • Candidates must possess advanced knowledge of Stage 2 Process Qualification and Stage 3 Continued Process Verification within a GMP environment.
  • This position serves as a technical reference point and Subject Matter Expert during audits, inspections, and cross-functional project execution.

Matching Summary

The role independently manages the full lifecycle of validation and continued process verification for sterile manufacturing processes.

Skills & Requirements

Must-have

  • Sterile manufacturing process validation
  • Cleaning validation and contamination control
  • Aseptic process simulations (APS/Media Fill)
  • Stage 2 Process Qualification execution
  • Continued Process Verification (CPV) management
  • Risk assessment methodologies (FMEA)
  • GMP compliance for FDA/EMA sterile products

Nice-to-have

  • Shift and weekend availability for critical phases
  • Own vehicle for commuting to workplace
  • Experience with lyophilized product validation
  • Advanced Excel skills for statistical analysis
  • Cross-functional team leadership capabilities

Key Requirements

  • Bachelor's Degree in Pharmaceutical Chemistry, Chemistry, Biotechnology or related field
  • Minimum 3–5 years experience in Process & Cleaning Validation
  • Proven experience with sterilizing filtration and aseptic liquid filling
  • Valid work authorization for UK employment required

Work Rights

Not specified

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