🔍 Commissioning & Qualification Lead Consultant

📍 Location: East Puerto Rico

🗓️ Availability: Immediate

💼 Work Setting: Onsite

📋 Position Overview

Our client is seeking a Commissioning & Qualification Lead Consultant to support Drug Product operations and lead commissioning, qualification, and validation activities within a regulated manufacturing environment.

The ideal candidate will provide technical leadership across C&Q, validation, engineering, and qualification activities, ensuring alignment with project requirements, quality standards, and applicable regulatory expectations.

🔧 Key Responsibilities

• Lead and support Commissioning & Qualification (C&Q) activities for Drug Product manufacturing areas.
• Develop and execute validation and qualification strategies, plans, protocols, and reports.
• Provide SME support throughout design, engineering, commissioning, and qualification phases.
• Support facility, utility, HVAC, equipment, and environmental qualification activities.
• Review and provide input on URS, design documentation, risk assessments, FAT/SAT, commissioning activities, and qualification deliverables.
• Coordinate qualification activities with Engineering, Quality, Manufacturing, Process Development, vendors, and external service providers.
• Support the integration of commissioning, qualification, validation, and process-related activities.
• Evaluate and coordinate resources, schedules, deliverables, and execution activities throughout the project lifecycle.
• Ensure documentation and execution activities remain aligned with cGMP and applicable validation requirements.
• Support troubleshooting, issue resolution, and execution of qualification activities within Drug Product manufacturing environments.

🛠️ Required Experience & Skills

• Strong experience in Commissioning, Qualification, and Validation (CQV/C&Q) within pharmaceutical or other regulated manufacturing environments.
• Hands-on experience supporting Drug Product manufacturing operations, preferably sterile manufacturing.
• Experience with equipment, facilities, utilities, HVAC, and environmental qualification.
• Knowledge of validation lifecycle and qualification documentation.
• Experience with FAT/SAT, risk assessments, commissioning activities, and qualification protocols.
• Strong understanding of cGMP requirements and validation practices.
• Experience working with validation and engineering systems/documentation platforms.
• Ability to lead cross-functional activities and coordinate with internal teams, vendors, and contractors.
• Strong technical writing, organization, problem-solving, and project leadership skills.

⭐ Ideal Candidate

A hands-on CQV/Validation professional with strong Drug Product experience who can provide technical oversight, coordinate multiple stakeholders, and drive qualification and validation deliverables from engineering through execution.