Cleaning Validation & Commissioning Specialist

Role: Engineer specializing in commissioning, qualification, and validation (CQV) within biopharma manufacturing, focusing on equipment, facilities, utilities, and processes. Objectives include ensuring high-quality, compliant products through risk-based evaluation, testing, and documentation aligned with regulatory standards. Responsibilities encompass developing and executing validation protocols, supporting project leadership, reviewing documentation, managing risk assessments, and supervising validation activities, including cleaning validation. Qualifications required are a Bachelor's in Engineering or related field, 3+ years of technical experience, with 6+ years in manufacturing, quality, or engineering, including validation expertise in areas like equipment, cleaning, or process validation. Experience in regulated industries such as pharmaceuticals, medical devices, or similar is preferred, alongside knowledge of regulatory and compliance standards (GxP, EHS). Strong interpersonal and project management skills are essential, with supervisory experience advantageous. High-value specifics include experience in validation for pharmaceutical or biologics manufacturing, regulatory scrutiny readiness, and risk management principles. The role may involve supervising contract personnel and coordinating validation activities aligned with regulatory and quality systems.