JT722 - SR. SPECIALIST TECH ENGINEERING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a Facilities and Engineering Support Specialist to join our team in Puerto Rico & USA. You will work within a world-class manufacturing environment, ensuring the integrity of F&E and AML facilities and supporting Quality Systems activities across deviations, CAPAs, and change controls.

You will investigate deviations, maintain compliant documentation, and collaborate with cross-functional teams to implement CAPA actions, while ensuring records meet

Qualifications

• Bachelor’s degree required; 8+ years direct experience in pharma/biotech environments.
• Experience with Quality Systems, deviations, CAPA management, Change Controls, and controlled documentation.
• Strong knowledge of regulatory requirements and validation/documentation processes.

Responsibilities

• Maintain integrity and compliance of F&E and AML manufacturing facilities.
• Support Quality Systems activities including deviations, CAPAs, Change Controls, and documentation.
• Investigate deviations and document investigations per SOPs; drive timely CAPA closure.
• Ensure records are complete, accurate, and inspection-ready.

Skills

Quality Systems

CAPA management

Change Controls

Documentation

Regulatory compliance

HVAC systems expertise

Problem solving

Education

Bachelor’s degree in related area

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly dynamic, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of F&E and AML manufacturing facilities
• This role involves providing crucial support in Quality Systems, including deviations, Corrective and Preventive Actions (CAPAs), Change Controls, documentation changes, pest control program management support, and OEFM electronic forms
• Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation
• Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs)
• Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready
• Facilitate and manage documentation changes related to facilities and engineering processes
• Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices
• Collaborate with relevant stakeholders to implement documentation changes efficiently
• Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms
• Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines
• Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues
• Support the transformation of the Pest Control program into a state of the art program
• Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues
• Support the documentation and records related to the pest control program
• Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities
• Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation
• Maintain Change Control records and provide support during regulatory inspections
• Evaluate and optimize Preventive & Predictive maintenance Job Plans at the HVAC/Process Chilled Water & Cooling Towers systems
• Support Maintenance technical teams on the corrective and troubleshooting activities on the exposed systems above
• Serves as a peer recognized as technical expert in the area of chilled water, cooling towers and HVAC, with overall responsibility for determining methodologies in that area
• Operate under a culture of problem solving and continuous improvement
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents

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 the following areas: Negotiation, Persuasion, Collaboration, Project cost development, Conflict Resolution, Leadership, Team building & Schedule and Resources loading development
• First shift