LL03-251105 CIP/SIP CQV Lead for Biotech

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CIP/SIP CQV Lead for Biotech

The CIP/SIP CQV Lead is responsible for the planning, coordination, and execution of 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
CQV Planning & Strategy

• Develop and maintain the CIP/SIP CQV Plan, integrating it with the overall project CQV Master Plan.
• Define the CQV scope, strategy, and approach for all CIP and SIP skids, loops, and interfaces.
• Coordinate with process design, automation, and operations teams to ensure system functionality meets User Requirements Specifications (URS).
• Lead risk assessments (RA/IOQ/Performance Qualification) and ensure alignment with site validation policies.

Commissioning & Qualification Execution

• Review and approve vendor FAT/SAT protocols for CIP/SIP equipment.

• Lead and oversee execution of IOQ and PQ protocols for CIP/SIP systems, including:

• Cleaning recipe verification

• Steam sterilization cycle qualification
• Temperature mapping, time/temperature distribution, and drainability studies
• Ensure qualification of utilities supporting CIP/SIP systems (Clean Steam, WFI, Process Air).
• Interface closely with Automation, Process, and QA Validation for recipe verification and data integrity.

Documentation & Compliance

• Develop 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.
• Manage deviations, non-conformances, and change controls related to CIP/SIP systems.
• Prepare summary reports and ensure timely approval from Quality Assurance.

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
Education

• Bachelor's degree in Chemical, Mechanical, or Biochemical Engineering (or equivalent).

Experience

• Minimum 7–10 years of experience in CQV within biotech or pharmaceutical manufacturing environments.
• At least 3 years leading CQV activities for CIP/SIP systems or related sterile process equipment.
• Strong knowledge of cleaning validation, sterilization principles, and automation integration.
• Experience with DeltaV, SCADA, or PLC systems for CIP/SIP recipe management.

Technical Competencies

• 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.
• Familiarity with data integrity, 21 CFR Part 11, and electronic validation systems (e.g., Kneat, ValGenesis).

Soft Skills

• Excellent leadership and coordination abilities in multi-disciplinary project environments.
• Strong communication skills for interaction with QA, Engineering, and Operations.
• Analytical, detail-oriented, and proactive problem-solver.
• Capable of managing timelines, priorities, and multiple concurrent systems.

Preferred

• Experience with bioreactor, media/buffer prep, and downstream CIP/SIP integrations.
• Prior participation in greenfield or expansion projects for biotech facilities.
• Familiarity with LEED / sustainability concepts in clean utility systems.

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