Validation Specialist (Cleaning-In-Place)
On-site · Carolina, North Carolina, United States
Job Summary
Validation Specialist - CIP/SIP CQV activities in a biotech/pharmaceutical manufacturing environment. Lead planning, coordination, and execution of Commissioning, Qualification, and Validation for CIP/SIP systems; ensure compliance with GMP, FDA, EMA, and ASTM E2500; generate and review URS, FAT/SAT, IOQ, PQ documentation; oversee utilities qualification (clean steam, WFI, Process Air); collaborate with Automation, Process, QA Validation; provide training and guidance to CQV engineers and contractors; support process validation batches and cleaning validation campaigns; bilingual English/Spanish; extended hours may be required.
Required Qualifications
- Bachelor’s degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent)
- Minimum 7-10 years of experience in CQV within biotech or pharmaceutical manufacturing environments
- Experience in generating and executing documentation for CQV activities
- Strong knowledge of cleaning validation, sterilization principles, and automation integration
- Familiarity with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management
- Expertise in ASTM E2500, ISPE Baseline Guides, GAMP 5, and FDA/EMA guidelines
- Proficiency in reviewing P&IDs, piping isometrics, and functional design specifications
- Experience executing or overseeing FAT/SAT, IOQ, PQ activities
- Knowledge of data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis)
- Must be fully bilingual (English / Spanish) with excellent oral skills
- Available to work extended hours, possibility of weekends and holidays
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