Quality Systems Engineer: CAPA, Change Controls & HVAC

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QUALITY CONSULTING GROUP is seeking a Facilities and Engineering Support Specialist to maintain compliance for F&E and AML manufacturing facilities in Puerto Rico and the USA. You will support Quality Systems activities, investigate deviations, and manage CAPAs and change controls.

The role requires 8 years of related experience, a Bachelor's degree, and expertise in HVAC systems, chilled water, and validated documentation within a regulated environment.

Qualifications

• Bachelor's degree in related area
• 8 years of directly related experience
• Working knowledge of pharmaceutical/biotech processes
• Experience with Quality Systems, particularly deviations, CAPA management, Change Controls, and controlled documentation
• Specialized industrial chilled water, cooling towers and HVAC systems expertise
• Familiarity with validation and documentation processes in a highly regulated environment
• Deviations and CAPA management capabilities
• Problem solving skills with the ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting
• Flexibility to work extended shift and/or weekends as per business needs
• Skills in Negotiation, Persuasion, Collaboration, Project cost development, Conflict Resolution, Leadership, Team building & Schedule and Resources loading development
• First shift

Responsibilities

• Maintain the integrity and compliance of Facilities & Engineering (F&E) and AML manufacturing facilities.
• Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
• Investigate and document deviations from established procedures following SOPs.
• Collaborate with Quality team and stakeholders to initiate, implement, monitor, and close CAPAs.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
• Facilitate and manage documentation changes related to facilities and engineering processes.
• Ensure documentation changes adhere to regulatory guidelines and internal quality standards.
• Collaborate with cross-functional teams to resolve form-related questions or issues.
• Support the pest control program transformation and collaborate with pest control vendors.
• Support Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities
• Maintain Change Control records and provide support during regulatory inspections
• Evaluate and optimize Preventive & Predictive maintenance plans on HVAC, cooling towers, and related systems
• Serve as a technical expert in chilled water, cooling towers, and HVAC to determine methodologies
• Coordinate with project managers and stakeholders on design and engineering projects
• Coordinate work of consultants, architects, and engineering firms on standard design documents

Skills

Quality Systems

CAPA management

Change Controls

Troubleshooting

Problem solving

Leadership

Team building

Education

Bachelor's degree

Tools

HVAC systems

Job description

QUALITY CONSULTING GROUP is seeking a Facilities and Engineering Support Specialist to maintain compliance for F&E and AML manufacturing facilities in Puerto Rico and the USA. You will support Quality Systems activities, investigate deviations, and manage CAPAs and change controls.

The role requires 8 years of related experience, a Bachelor's degree, and expertise in HVAC systems, chilled water, and validated documentation within a regulated environment.