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 – Building Automation Systems (BAS) / Qualified BAS (QBAS)

Overview:

We are seeking a knowledgeable and experienced Commissioning and Qualification (C&Q) Specialist to focus on the Building Automation Systems (BAS) and Qualified BAS (QBAS) for a major capital project in the pharmaceutical, biotechnology, or life sciences industry. The specialist will ensure that the automation systems for critical utilities, facilities, and environmental monitoring meet operational readiness, compliance, and validation requirements per industry regulations (cGMP).

Key Responsibilities:

Building Automation System (BAS) Commissioning:

• Develop and execute commissioning protocols and documentation (FAT, SAT, IOQ) for Building Automation Systems (BAS).
• Validate the performance and functionality of BAS components, including:
• Environmental monitoring (temperature, humidity, pressure)
• HVAC control systems
• Alarms and notifications (including critical alarms)
• Integration with utilities, facilities, and process control systems.
• Verify system programming, calibration, and network communication protocols.

Qualified BAS (QBAS) Qualification:

• Support Qualification of BAS (QBAS) in GMP-regulated environments, ensuring compliance with industry regulations and standards.
• Ensure the system complies with ISPE GAMP5, FDA 21 CFR Part 11, Annex 11, and other applicable guidelines.
• Execute risk-based approaches for validation, ensuring critical parameters and systems are identified and prioritized.
• Work with automation engineers to configure BAS functionalities that meet URS and operational needs.

System Integration and Testing:

• Oversee integration of BAS with qualified systems, such as clean utilities, equipment, and environmental monitoring systems (EMS).
• Perform testing for data accuracy, real-time monitoring, and alarm functionality.
• Ensure proper interface and communication between BAS and other control systems (e.g., SCADA, DCS).

Project Management and Collaboration:

• Collaborate with engineering, quality, and operations teams during system design, start-up, commissioning, and qualification phases.
• Coordinate activities with vendors, contractors, and third-party providers for BAS installation and qualification.
• Manage project schedules and ensure timely execution of BAS commissioning and qualification deliverables.

Documentation and Compliance:

• Author, review, and approve commissioning and qualification documents, including:
• User Requirement Specifications (URS)
• Functional Specifications (FS)
• Design Qualification (DQ)
• Commissioning protocols and validation reports.
• Document and resolve deviations, ensuring all issues are remediated and closed per project timelines.
• Prepare system handover packages and ensure proper training for end-users and operators.

Qualifications:

Education and Experience:

• Bachelor’s degree in Engineering, Automation, Life Sciences, or related technical field.
• Minimum 5 years of experience in commissioning, qualification, and validation of BAS/QBAS in GMP-regulated environments (pharma, biotech, life sciences).
• Experience with BAS platforms (e.g., Siemens, Honeywell, Rockwell Automation, Johnson Controls, or similar).

Technical Skills:

• Deep knowledge of GAMP5, ISPE guidelines, and regulatory requirements for automation systems.
• Strong understanding of control systems, HVAC functionality, environmental monitoring, and alarm management.
• Hands-on experience with validation lifecycle deliverables (URS, DQ, IQ, OQ, PQ).
• Familiarity with PLC/SCADA programming and network communication protocols (BACnet, Modbus, OPC, etc.).

Soft Skills:

• Excellent problem-solving and troubleshooting abilities in automated systems.
• Strong communication skills to work effectively with cross-functional teams.
• Highly organized with the ability to manage multiple tasks and priorities.
• Preferred Qualifications:
• Experience working on large-scale capital projects with complex BAS integrations.
• Certifications in automation or project management (e.g., PMP, Six Sigma).
• Knowledge of cybersecurity requirements for automation systems in GMP environments.