- Validation Specialist - CIP
Summary:
The Validation Specialist is responsible for planning, coordinating, and executing all Commissioning, Qualification, and Validation (CQV) activities related to Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems within a biotech manufacturing environment. This role ensures that cleaning and sterilization systems are installed, tested, and qualified in compliance with GMP, FDA, EMA, and ASTM E2500 standards, supporting readiness for process validation and commercial manufacturing.
Key Responsibilities:
Commissioning & Qualification Execution:- Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.
- Execute IOQ and PQ protocols for CIP/SIP systems, including cleaning recipe verification, steam sterilization cycle qualification, and temperature mapping.
- Oversee the qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).
- Collaborate closely with Automation, Process, and QA Validation for recipe verification and data integrity.
Documentation & Compliance:- Generate and review URS, FAT/SAT, IOQ, and PQ documentation in compliance with ASTM E2500 and GAMP 5.
- Ensure traceability from design specifications through executed testing.
- Assist in managing deviations, non-conformances, and change controls related to CIP/SIP systems.
- Prepare summary reports for Quality Assurance approval.
Cross-functional Collaboration:- Collaborate with Process Engineers, Automation, QA, and Manufacturing to ensure successful integration of CIP/SIP operations with process equipment.
- Support operations during process validation batches and cleaning validation campaigns.
- Provide training and technical guidance to CQV engineers and contractors executing test protocols.
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.
