Biotech and Pharmaceutical, Change Control, Cleaning Equipment, Cross-Functional, Current Good Manufacturing Practice (cGMP), FDA (Food and Drug Administration), Maintain Compliance, Manufacturing, Medical Equipment, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Metrics, Regulatory Compliance, Risk, Risk Analysis, Strategic Analysis, Technical Writing, Validation Documentation
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:
- Senior Cleaning Validation Specialist
Summary:
Senior Cleaning Validation Specialist to support cleaning validation lifecycle activities within a regulated cGMP manufacturing environment. This role is critical in ensuring equipment cleaning processes meet regulatory and quality compliance standards.
Key Responsibilities
- Lead cleaning validation lifecycle activities
- Develop & review protocols and reports
- Define sampling strategies and risk assessments
- Establish acceptance criteria (PDE / MACO / HBEL)
- Support deviations, investigations & change controls
- Collaborate with Manufacturing, QA, Engineering & Labs
- Ensure compliance with FDA / EMA / cGMP requirements
Required Qualifications
- Bachelor’s degree in Science or Engineering.
- 5+ years of Cleaning Validation experience.
- Strong knowledge of PDE / MACO calculations.
- Experience with validation documentation.
- cGMP pharmaceutical or biotech background.
Preferred Experience
- Multi-product facilities
- Biotech / sterile manufacturing
- CIP / automated cleaning systems
- HBEL / toxicological risk assessments
Core Skills
- Technical writing
- Risk-based decision making
- Problem-solving & investigations
- Cross-functional collaboration
- Compliance-driven mindset
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Validation & Engineering Group, Inc