Cleaning Validation Specialist-Talent Bank

The Cleaning Validation Specialist is responsible for developing, executing, and maintaining cleaning validation protocols and procedures to ensure compliance with regulatory standards (e.g., FDA, EMA) and internal quality systems.

This role supports manufacturing operations by ensuring that equipment cleaning processes effectively remove residues and contaminants to prevent cross-contamination and ensure product quality.

Key Responsibilities : Develop, write, and execute cleaning validation protocols, including IQ, OQ, and PQ documents.

Conduct risk assessments and determine appropriate cleaning strategies based on product type, equipment, and process.

Coordinate cleaning validation and verification activities with manufacturing, quality, and engineering departments.

Collect and analyze cleaning validation data using statistical methods to determine process capability and compliance.

Author technical reports and summaries of validation results.

Support regulatory inspections and internal audits by providing documentation and technical justifications.

Manage lifecycle activities for cleaning validation, including re-validation assessments and periodic reviews.

Ensure all cleaning validation activities comply with cGMPs, FDA / EMA regulations, and company policies.

Maintain and update the cleaning validation master plan.

Investigate deviations and out-of-specification (OOS) results related to cleaning processes.

Provide training and guidance to relevant departments on cleaning procedures and validation requirements.

Qualifications : Bachelor’s Degree in Chemistry, Microbiology, Engineering, or a related scientific field.

2+ years of experience in a GMP-regulated environment, preferably in cleaning validation.

Strong knowledge of cleaning validation regulations, guidance documents (e.g., FDA, ICH, PDA), and industry best practices.

Familiarity with analytical techniques (e.g., TOC, HPLC, visual inspection).

Experience with writing technical documents, validation protocols, and final reports.

Excellent attention to detail, organizational, and communication skills.

Ability to work independently and manage multiple priorities.

Preferred Qualifications : Experience in pharmaceutical or biotechnology manufacturing.

Working knowledge of statistical software and validation lifecycle tools.

Knowledge of Six Sigma, Lean, or continuous improvement practices.

"Drug Free Workplace Policy : In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment." Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.

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