LL03-241216 Commissioning and Qualification (C&Q) Specialist – Warehouse Automation (ASRS & AGVs) - Validation & Engineering Group

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:

• Commissioning and Qualification (C&Q) Specialist – Warehouse Automation (ASRS & AGVs)

Overview:

We are seeking an experienced Commissioning and Qualification (C&Q) Specialist to support the implementation and qualification of Warehouse Automation Systems, including Automated Storage and Retrieval Systems (ASRS) and Automated Guided Vehicles (AGVs), as part of a major capital project in the pharmaceutical, biotechnology, or life sciences industry. The role focuses on ensuring these systems are commissioned, qualified, and compliant with cGMP standards while meeting operational and project goals.

Key Responsibilities:

Commissioning and Qualification of Warehouse Automation Systems:

• Develop, execute, and manage commissioning and qualification protocols (FAT, SAT, IOQ) for ASRS and AGVs.
• Validate the performance and functionality of warehouse automation components, including:
• ASRS systems (cranes, shuttles, conveyors).
• AGV systems (navigation, control, charging).
• Warehouse Management Systems (WMS) integration.
• Material handling equipment and interfaces with facility systems.
• Test operational workflows for material storage, retrieval, and transport to ensure system efficiency and reliability.

Regulatory Compliance:

• Ensure compliance with cGMP, FDA, EU, and other applicable standards for warehouse automation systems.
• Conduct risk-based qualification assessments, focusing on critical system aspects like traceability, inventory control, and data integrity.
• Validate data recording, audit trails, and system alarm functions to meet regulatory requirements (e.g., 21 CFR Part 11).

System Integration and Testing:

• Oversee the integration of ASRS and AGVs with Warehouse Management Systems (WMS), Enterprise Resource Planning (ERP), and other facility control systems.
• Perform end-to-end testing of automated workflows, including:
• Inventory tracking and material flow.
• Real-time communication between systems.
• System recovery and redundancy testing.
• Validate the performance of AGVs in dynamic warehouse environments, including navigation, load handling, and obstacle detection.

Project Management and Collaboration:

• Coordinate activities between vendors, contractors, and internal teams to ensure timely commissioning and qualification.
• Work closely with engineering, operations, and quality assurance teams to align on project deliverables.
• Monitor project milestones and address any delays or deviations to keep activities on track.

Documentation and Reporting:

• Prepare, review, and approve key project documents, including:
• User Requirement Specifications (URS).
• Functional Specifications (FS) and Design Qualification (DQ).
• FAT, SAT, and IOQ protocols and reports.
• Document and resolve non-conformances and deviations identified during C&Q activities.
• Provide final handover documentation, including system performance reports and training materials for operators.

Qualifications:

Education and Experience:

• Bachelor’s degree in Engineering, Automation, Supply Chain Management, or a related technical field.
• Minimum 5 years of experience in commissioning, qualification, and validation of warehouse automation systems (pharma, biotech, or life sciences preferred).
• Experience with ASRS and AGV technologies in regulated environments.

Technical Skills:

• In-depth knowledge of warehouse automation technologies, including ASRS, AGVs, WMS, and material handling equipment.
• Familiarity with GAMP5, ISPE guidelines, and cGMP validation requirements.
• Understanding of software validation, data integrity, and regulatory requirements for automated systems (21 CFR Part 11, Annex 11).
• Proficient in analyzing system performance, troubleshooting, and resolving automation issues.

Soft Skills:

• Strong problem-solving and analytical skills to optimize warehouse workflows.
• Excellent communication skills to work with cross-functional teams and vendors.
• Detail-oriented with the ability to manage multiple priorities effectively.
• Preferred Qualifications:
• Hands-on experience with warehouse automation platforms (e.g., Dematic, Swisslog, Daifuku, or similar).
• Certifications in automation or project management (e.g., PMP, Lean Six Sigma).
• Experience in large-scale capital projects and knowledge of logistics operations in GMP environments.